Treatment of warts

Abstract

The present invention provides a composition having a standardized potency for use in the treatment of warts, and a method for treating common warts. [Solution] A method for treating verruca vulgaris in a subject requiring treatment for the verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount effective for the complete disappearance of the verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

Description

Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 714,942, filed on August 6, 2018, and U.S. Provisional Application No. 62 / 880,742, filed on July 31, 2019, the entire contents of each of which are incorporated herein by reference.

Technical Field

[0002] The present disclosure relates to a therapeutic agent having a standardized titer for the complete disappearance of common warts and prevention of recurrence of common warts.

Background Art

[0003] Common warts are a skin infection caused by the human papillomavirus (HPV). This virus initially targets epidermal basal cells and induces hyperplasia and keratinocyte proliferation, which clinically appears as warts. Common warts are not life - threatening but can cause both physical discomfort and confusion to patients.

[0004] The overall prevalence of common warts in the United States is estimated to be 2 - 20%. However, for current treatment options for common warts, their effectiveness varies and often results in recurrence. Treatments including topical salicylic acid, topical imiquimod, bleomycin injection, cryotherapy, excision, electrocautery, and laser vaporization are used, and the associated results and side effects vary.

[0005] Immunotherapy using Candida albicans antigens is also being studied. However, varying levels of response have been reported. See Aldahan AS et al., “Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature,” Dermatologic Therapy 2016;29:197-207, Table 1; and Alikhhan A et al., “Use of Candida antigen injections for the treatment of verruca vulgaris: A two-year mayo clinic experience,” Journal of Dermatological Treatment 2016;27(4):355-58,355, Table 2. The inconsistent results are likely due to the use of different Candida antigen sources in these studies, resulting in significantly different concentrations and titers. For example, two studies utilized Candida antigens obtained from Hollister-Stier (Alikan et al. at 355 and Perman M et al., “The painful purple digit: an alarming complication of Candida albicans antigen treatment of recalcitrant warts,” Dermatitis: Contact, Atopic, Occupational, Drug 2005;16(1):38-40 (cited by Aldahan et al.)), and another study utilized Candida antigens obtained from Bayer (Johnson et al., “Intralesional injection of mumps or candida skin test antigens: a novel immunotherapy for warts,” Arch Dematol. 2001;137:451-55 (cited by Aldahan et al. and Alikan et al.)), and another study utilized Candida antigens obtained from Bayer (Johnson et al., “Intralesional injection of mumps or candida skin test antigens: a novel immunotherapy for warts,” Arch Dematol. 2001;137:451-55 (cited by Aldahan et al. and Alikan et al.)).(Cited in)), another study used Candida antigen obtained from Creative Drug Industries (Majid I and Imran S, “Immunotherapy with Intralesional Candida Albicans Antigen in Resistant or Recurrent Warts: A Study,” Indian Journal of Dermatology 2013:58(5):360-65 (Cited in Aldahan et al. and Alikhhan et al.)), and another study used Candin® manufactured by Allermed Laboratories (Kim KH et al., “Phase 1 clinical trial of intralesional injection of Candida antigen for the treatment of warts,” Arch Dematol 2010,146(12):1431-33; Pfenninger JL and Fowler GC, “Procedures for Primary Care,” Third Edition, Elsevier 2010,639-43; Signor RJ, “Candida Albicans Intralesional Injection Immunotherapy of Warts, Cutis 2002;70:185-92 (cited by Alikhhan et al.); Phillips RC et al., "Treatment of Warts with Candida Antigen Injection," Arch Dematol 2001,136(10):1274-5; Wong A and Crawford RI, "Intralesional Candida antigen for common warts in people with HIV," J Cutan Med Surg. 2013;17(5):313-15 (cited by Aldahan et al.). Some studies do not report on the source of the Candida antigen. Summers P et al.,“Treatment of recalcitrant verruca vulgaris with Candida antigen in patient with human immunodeficiency virus,”J Drugs Dermatol 2009;8(3): 268-69(cited in Aldahan et al.);“Warts Refractory to Conventional Therapy Yield to Candida Antigen,”American Academy of Family Practice 90 Clinical Perspectives 1990;Harada S, “Clinical See Application of Fungus Extracts and its Culture filtrate in the Treatment of Skin Diseases: (3) Candida Vaccine in the Treatment of Warts,” Japanese Journal of Dermatology 1979;89(6), 397-402. .

[0006] Therefore, considering the various sources being studied, the doses reported in volume and weight / volume (v / w) dilutions do not provide physicians with sufficient information to achieve consistent verrucae cure rates. At best, the administration of the antigen based on an early delayed-type hypersensitivity (DTH) response is shown in U.S. Patents 6,350 and 451 for Horn. See the example in Patent 451. For this reason, a Candida antigen composition with a standardized potency for the treatment of verrucae is desired. [Overview of the project]

[0007] This disclosure provides, including, compositions having a standardized potency for use in the treatment of one or more common or non-common warts. This disclosure also provides, including, methods for treating one or more common or non-common warts.

[0008] In one embodiment, the Disclosure provides a method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency in an amount effective for the complete disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0009] In one embodiment, the Disclosure provides, and includes, a method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency in an amount sufficient to cause complete clearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0010] In one embodiment, the Disclosure provides, and includes, a method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial clearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0011] In one embodiment, the Disclosure provides, and includes, a method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount capable of partial disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0012] In one embodiment, the Disclosure provides a method for treating multiple verruca vulgaris in a subject requiring treatment for such multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 unit potency in an amount effective for partial clearance of the multiple verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0013] In one embodiment, the Disclosure provides a method for treating multiple verruca vulgaris in a subject requiring treatment for such multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount capable of partial disappearance of the multiple verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0014] In one embodiment, the Disclosure provides a method for treating a plurality of verruca vulgaris in a subject requiring treatment of said plurality of verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of one unit potency that is effective in reducing the diameter of each of the plurality of verruca vulgaris by at least 50%, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0015] In one embodiment, the Disclosure provides a method for treating a plurality of verruca vulgaris in a subject requiring treatment of said plurality of verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in an amount capable of reducing the diameter of each of the plurality of verruca vulgaris by at least 50% in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0016] In one embodiment, the Disclosure provides, and includes, a method for treating non-verrucae in a subject having one or more verrucae in a subject requiring treatment for non-verrucae in which the subject has one or more verrucae in which the subject is administered one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for the complete disappearance of the non-verrucae in which the subject is, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0017] In one embodiment, the Disclosure provides, and includes, a method for treating non-verruca vulgaris in a subject having one or more verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 unit potency in an amount capable of completely clearing the non-verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0018] In one embodiment, the Disclosure provides a method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for complete clearance of said previously treated verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0019] In one embodiment, the Disclosure provides a method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of completely clearing the said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0020] In one embodiment, the Disclosure provides a method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in an amount effective in delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, in a cumulative dose of 2.5 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0021] In one embodiment, the Disclosure provides a method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount capable of delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0022] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to cause complete elimination of verruca vulgaris at a cumulative dose of 2.5 unit potency.

[0023] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially clear verruca vulgaris at a cumulative dose of 5 units potency.

[0024] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of a common wart by at least 50% in a cumulative dose of one unit potency.

[0025] In one aspect, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and secreted antigens, formulated at a cumulative dose of 5 unit titers to cause partial disappearance of multiple common warts. This is included.

[0026] In one aspect, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and secreted antigens, formulated at a cumulative dose of 1 unit titer to reduce the diameter of multiple common warts by at least 50%. This is included.

[0027] In one aspect, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and secreted antigens, formulated at a cumulative dose of 5 unit titers to cause complete disappearance of an atypical wart. This is included.

[0028] In one aspect, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and secreted antigens, formulated at a cumulative dose of 5 unit titers to cause complete disappearance of previously treated common warts. This is included.

[0029] In one aspect, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and secreted antigens, formulated at a cumulative dose of 2.5 unit titers at the time of disappearance of common warts to delay the recurrence of the common warts. This is included.

[0030] In one embodiment, the Disclosure provides, including, a method for reducing the level of IL-23 in a subject requiring a reduction in the level of IL-23, comprising administering to the subject one or more intrafocal injections of one amount of a pharmaceutical composition in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one common wart. In one embodiment, the Method of the Disclosure reduces the level of IL-23 in the subject by at least about 15% compared to the level of IL-23 measured in the subject prior to the administration step, upon receiving one cumulative dose of the Pharmaceutical Composition of the Disclosure. In one embodiment, the Method of the Disclosure reduces the level of IL-23 in the subject by at least about 35% compared to the level of IL-23 measured in the subject prior to the administration step, upon receiving one cumulative dose of the Pharmaceutical Composition of the Disclosure.

[0031] In one embodiment, the Disclosure provides, including, a method for the complete elimination of common warts in a subject requiring complete elimination of such warts, comprising reducing the level of IL-23 in the subject requiring complete elimination of such warts by at least about 15%. In one embodiment, the Disclosure provides, including, a method for the complete elimination of common warts in a subject requiring complete elimination of such warts, comprising reducing the level of IL-23 in the subject requiring complete elimination of such warts by at least about 35%. In one embodiment, the Method of the Disclosure reduces the level of IL-23 by administering to a subject one or more intralesional injections of one amount of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0032] In one embodiment, the Disclosure provides a method for reducing the level of IL-7 in a subject requiring a reduction in the level of IL-7, comprising administering to the subject one or more intrafocal injections of one volume of a pharmaceutical composition in a cumulative dose of 0.6 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris. In one embodiment, the method of the Disclosure reduces the level of IL-7 in the subject by at least about 10% compared to the level of IL-7 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the Disclosure.

[0033] In one embodiment, the Disclosure provides a method for reducing the level of IL-7 in a subject that needs to have a reduction in the level of IL-7, comprising administering to the subject one or more intrafocal injections of one amount of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris. In one embodiment, the method of the Disclosure reduces the level of IL-7 in the subject by at least about 20% compared to the level of IL-7 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the Disclosure.

[0034] In one embodiment, the Disclosure provides a method for reducing the level of IP-10 in a subject requiring a reduction in the level of IP-10, comprising administering to the subject one or more intralesional injections of one volume of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one common wart. In one embodiment, the Method of the Disclosure reduces the level of IP-10 in the subject by at least about 5% compared to the level of IP-10 measured in the subject prior to the administration step, upon receiving one cumulative dose of the Pharmaceutical Composition of the Disclosure.

[0035] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising filtered extracts of Candida albicans and secretory antigens for use in a subject requiring a reduction in IL-23 levels. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0036] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, used to completely eliminate verruca vulgaris in a subject requiring complete elimination of verruca vulgaris by reducing the level of IL-23 in that subject by at least about 35%. In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, used to completely eliminate verruca vulgaris in a subject requiring complete elimination of verruca vulgaris by reducing the level of IL-23 in that subject by at least about 15%.

[0037] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising filtered extracts of Candida albicans and secretory antigens for use in a subject requiring a reduction in IL-7 levels. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0038] In one embodiment, the Disclosure provides, including, a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, used for reducing IP-10 levels in a subject requiring such reduction. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0039] This disclosure is made with reference to the attached drawings. [Brief explanation of the drawing]

[0040] [Figure 1] Figure 1 shows the characteristic morphology of an isolated colony of the first strain of Candida albicans deposited as ATCC accession number PTA-126019 pursuant to this disclosure. [Figure 2] Figure 2 shows characteristic morphology of an isolated colony of a second strain of Candida albicans deposited as ATCC accession number PTA-126020 in accordance with this disclosure. [Figure 3] Figure 3 shows a typical appearance of a budding yeast cell of Candida albicans according to this disclosure. [Figure 4] Figure 4 shows a typical appearance of pseudohyphae of Candida albicans in accordance with this disclosure. [Figure 5] Figure 5 shows an example of a track grid on the back of a guinea pig in accordance with this disclosure. [Figure 6] Figure 6 shows the preferred location for intra-lesional injection. [Figure 7A]Figures 7A, 7B, and 7C show a comparison of changes in biomarker levels of IL-7, IP-10, and IL-23 within the treatment group and placebo group, respectively, in accordance with this disclosure. [Figure 7B] Figures 7A, 7B, and 7C show a comparison of changes in biomarker levels of IL-7, IP-10, and IL-23 within the treatment group and placebo group, respectively, in accordance with this disclosure. [Figure 7C] Figures 7A, 7B, and 7C show a comparison of changes in biomarker levels of IL-7, IP-10, and IL-23 within the treatment group and placebo group, respectively, in accordance with this disclosure. Detailed description of the invention

[0041] This disclosure provides, including, pharmaceutical compositions having a standardized potency for use in the treatment of one or more common or non-common warts. In one embodiment, the treatment of one or more common or non-common warts means a therapeutic treatment of these warts. In one embodiment, the treatment of one or more common or non-common warts means providing a preventive or protective measure against the occurrence of warts. In one embodiment, the pharmaceutical compositions of this disclosure enable the complete disappearance of one or more common and non-common warts by a cumulative dose delivered at a unit potency according to this disclosure. In one embodiment, the pharmaceutical compositions of this disclosure enable the partial disappearance of one or more common warts by a cumulative dose delivered at a unit potency according to this disclosure. In one embodiment, the pharmaceutical compositions of the present disclosure, by cumulative doses delivered at a unit potency in accordance with the present disclosure, can delay the reappearance of one or more common warts upon the disappearance of one or more common warts.

[0042] The Disclosure also provides, and includes, methods for treating one or more common or non-common warts using the pharmaceutical compositions described herein. In one embodiment, a method is provided for the complete disappearance of one or more common or non-common warts. In one embodiment, a method is provided for the partial disappearance of one or more common warts. In one embodiment, a method is provided for treating previously treated common warts. In one embodiment, a method is provided for delaying the reappearance of common warts.

[0043] Unless otherwise defined herein, terms shall be understood in accordance with the conventional usage of those skilled in the art. Where a term is given in the singular form, the inventors also intend aspects of this disclosure that are described by the plural form of that term. If there is any inconsistency between terms and definitions used in references invoked by reference, the terms used in this application shall have the definitions given herein. Other technical terms used shall have the common meaning in the art in which they are used, as exemplified by various art-specific dictionaries (e.g., “The American Heritage® Science Dictionary” (Editors of the American Heritage Dictionaries, 2011, Houghton Mifflin Harcourt, Boston and New York); the “McGraw-Hill Dictionary of Scientific and Technical Terms” (6th edition, 2002, McGraw-Hill, New York); or the “Oxford Dictionary of Biology” (6th edition, 2008, Oxford University Press, Oxford and New York)).

[0044] All publications, patents, and patent applications referenced in this disclosure are incorporated herein by reference to the same extent as each individual publication or patent application is specifically and individually incorporated herein by reference.

[0045] When the term "and / or" is used in a list of two or more items, it means that any one or more of the listed items may be used alone or in combination with any one or more of the listed items. For example, the expression "A and / or B" is intended to mean both A and B or either one of them, i.e., A only, B only, or a combination of A and B. The expression "A, B, and / or C" is intended to mean A only, B only, C only, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C.

[0046] As used herein, singular words and singular forms, such as "a," "an," and "the," refer to multiple objects unless otherwise explicitly stated in context.

[0047] Where a range of values ​​is given, it should be understood that each value between the upper and lower limits of that range, and any other stated values ​​within or between those limits, are included in this disclosure. The upper and lower limits of these smaller ranges may be independently included within those smaller ranges, and these are also included in this disclosure and subject to any specifically excluded limitations within the stated range. If the stated range includes one or both of the upper and lower limits, the range excluding one or both of these included upper and lower limits is also included in this disclosure. Whenever the expression “comprising” is used, variations such as “essentially consisting of” and “consisting of” are also intended.

[0048] Where used herein, the term “approximately” is intended to relax the numerical value it modifies, indicating such values ​​as variables within an error range. Unless a specific error range (e.g., standard deviation relative to the mean) is given, “approximately” should be understood to mean the range encompassing the given value, or the range included by rounding that number up or down to account for significant figures.

[0049] As used herein, the “pharmaceutical composition” in this disclosure may be an antigen or its solvate as described herein.

[0050] As used herein, “excipient” means a substance formulated together with the active ingredient of a pharmaceutical product. Excipients may be used for the purpose of long-term stabilization or to impart therapeutic enhancement to the active ingredient in the final dosage form, for example, to enhance the absorption of the active ingredient, reduce viscosity, or enhance solubility. Excipients may also be useful in the manufacturing process, for example, by aiding in vitro stability (e.g., preventing denaturation or aggregation over the expected storage period), and by promoting the flowability or non-stickiness of the powder, thereby assisting in the handling of the active substance in question.

[0051] As used herein, “pharmaceutically acceptable carriers” include all solvents, dispersions, antibacterial and antifungal agents, isotonic agents and absorption retarders, etc. The use of such media and agents for pharmaceutically active substances is well known in the art. Any conventional media or agent is intended to be used in a pharmaceutical composition unless it is incompatible with the pharmaceutical composition. As used herein, the expression “pharmaceutically, pharmacologically, or physiologically acceptable” means molecular entities and compositions that do not cause adverse reactions, allergic reactions, or other side effects when administered to animals or humans. pharmaceutically acceptable carriers can be diluents, adjuvants, excipients, or acid-resistant encapsulating components in liquid (e.g., saline), gel, or solid form. Suitable diluents and excipients include pharmaceutical-grade saline, dextrose, glycerol, mannitol, lactose, starch, magnesium stearate, sodium saccharin, cellulose, magnesium carbonate, etc., and combinations thereof.

[0052] As used herein, the term “pharmaceutically acceptable solvate” means a compound of the present disclosure associated with one or more solvent molecules. Examples of solvents that form pharmaceutically acceptable solvates include, but are not limited to, water, isopropanol, ethanol, methanol, DMSO, ethyl acetate, acetic acid, and ethanolamine.

[0053] As used herein, the term “to treat” means (i) to completely or partially inhibit a disease, disorder, or condition, e.g., to prevent its onset; (ii) to completely or partially alleviate a disease, disorder, or condition, e.g., to cause a reduction in the disease, disorder, and / or condition; or (iii) to completely or partially prevent a disease, disorder, or condition from occurring in a patient who may have a predisposition to such disease, disorder, and / or condition but has not yet been diagnosed with it. Similarly, “treatment” means both therapeutic procedures and preventive or protective measures. For example, the methods or compositions provided herein can be used to delay the progression of a condition (e.g., warts). As used herein, “to delay” the progression of a condition means to postpone, interfere with, slow down, delay, stabilize, and / or postpone the onset of the condition. The length of this delay may vary depending on the history of the condition and / or the individual being treated.

[0054] As used herein, the term “verruca” means a growth on the skin caused by the human papillomavirus.

[0055] As used herein, the term “anatomical region” means any one of the following regions of the body in question: the left arm, the right arm, the left hand, the right hand, the left lower limb, the right lower limb, the left foot, the right foot, and the torso. As used herein, the arm region includes the shoulder, upper arm and forearm, wrist, and half of the axilla. As used herein, the hand region begins distal to the wrist and excludes perineal warts. As used herein, the foot begins distal to the ankle and excludes the sole. As used herein, the lower limb region includes the upper leg, lower leg, and ankle. As used herein, the torso region includes the neck, back, chest, abdomen, buttocks, and pelvic region.

[0056] As used herein, the term “refractory warts” means warts that have not been successfully treated by prior therapies other than over-the-counter (OTC) medications. As used herein, the term “OTC medication” means medicines that are sold directly to consumers without a prescription from a healthcare professional.

[0057] As used herein, the term “margin” means the peripheral edge of a wart.

[0058] As used herein, the term “recurrence” means the growth of a wart in the same location where a previously regressed wart had been present.

[0059] As used herein, the term “complete disappearance” means the sustained disappearance of the warts, which is reflected by the absence of recurrence of warts at least 20 weeks after the administration of the first intralesional injection.

[0060] As used herein, the term “partial disappearance” means that the diameter of the wart is arbitrarily reduced compared to the diameter observed before the first intralesional injection.

[0061] As used herein, the terms “administer,” “to administer,” or “administer” with respect to the dosage forms of this disclosure mean the act of introducing the dosage form into a system of a subject requiring treatment. Where the dosage forms of this disclosure are shown in combination with one or more other active agents (in each dosage form), “administration” and its variations should be understood to include the simultaneous and / or time-dependent introduction of the dosage form and other active agents, respectively. Administration of any described dosage form may include simultaneous (parallel) administration, time-dependent (stepwise) administration, co-administration, or separate administration, in which the therapeutic agents are administered separately and approximately simultaneously, for example, from each other within a few seconds to a few hours.

[0062] As used herein, the term “pharmaceutical” means a substance used to treat a disease.

[0063] As used herein, the term "molecular weight" means the average mass of the molecule of interest relative to one-twelfth of the mass of carbon-12. Molecular weight is expressed in units of daltons (Da). Molecular weight is measured by a method using a superposition-12 column calibrated with dextran standards having molecular weights between 1 kilodalton and 512 kilodaltons.

[0064] As used herein, the term "IL-23" means interleukin-23, which is a heterodimer cytokine having p19 and p40 subunits.

[0065] As used herein, the term "IL-7" refers to interleukin-7, which is a cytokine important in the development of B and T cells.

[0066] As used herein, the term "IP-10" refers to interferon-gamma-inducible protein, also known as CXCL10.

[0067] A. Manufacturing process of pharmaceutical compositions In one embodiment, a pharmaceutical composition of the present disclosure comprising Candida albicans and a filtered extract of a secretory antigen can be prepared by a series of steps including growing two or more strains of Candida albicans separately, pooling cultures of the two or more strains of Candida albicans and dialyzing the mixture, heating the mixture, freeze-drying the heated dialyzing material, producing a dry powder, extracting the dry powder, filtering the extract, and producing a master lot filtered solution. In one embodiment, a pharmaceutical composition of the present disclosure can be produced by the protocol outlined in Example 1.

[0068] In one embodiment, the pharmaceutical composition of the Disclosure may be prepared using two or more strains of Candida albicans, for example, two, three, four, five, six, seven, eight, nine, or ten strains. In one embodiment, the pharmaceutical composition of the Disclosure is prepared using two strains of Candida albicans. In one embodiment, the pharmaceutical composition of the Disclosure is prepared using strains of Candida albicans as shown in Hasenclever HF and Mitchell WO, “Antigenic Studies of Candida,” Journal of Bacteriology 1961;82:578-581. In one embodiment, the pharmaceutical composition of the present disclosure is prepared using two strains of Candida albicans, wherein a representative sample of the first strain is deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain is deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain is deposited with ATCC under ATCC accession number ATCC-10231.

[0069] In one embodiment, the master lot filtration solution can be diluted with a diluent at a volume ratio of approximately 2:998 to form a pharmaceutical composition, meaning that 2 ml of the master lot filtration solution is diluted with 988 ml of the diluent. In one embodiment, the master lot filtration solution can be diluted with a diluent in a volume ratio range of approximately 2:998 to approximately 1:1, for example, approximately 2:998 to approximately 10:990, approximately 10:990 to approximately 20:980, approximately 20:980 to approximately 30:970, approximately 30:970 to approximately 40:960, approximately 40:960 to approximately 50:950, and approximately 50:950 to approximately 60:940. It can be diluted in the following ranges: approximately 60:940 to 70:930, approximately 70:930 to 80:920, approximately 80:920 to 90:910, approximately 90:910 to 1:9, approximately 1:9 to 1:8, approximately 1:8 to 1:7, approximately 1:7 to 1:6, approximately 1:6 to 1:5, approximately 1:5 to 1:4, approximately 1:4 to 1:3, approximately 1:3 to 1:2, and approximately 1:2 to 1:1. In one embodiment, the master lot filtration solution is not diluted in the pharmaceutical composition.

[0070] In one embodiment, the Disclosure provides a pharmaceutical composition comprising at least 80% mannose, for example, 80% to 85% mannose, 85% to 90% mannose, or 80% to 90% mannose. In one embodiment, the Disclosure provides a pharmaceutical composition comprising at least 8% glucose, for example, 8% to 10% glucose, 10% to 12% glucose, or 8% to 12% glucose. In one embodiment, the Disclosure provides a pharmaceutical composition comprising at least 1% galactose, for example, 1% to 2.5% galactose, 2.5% to 5% galactose, or 1% to 5% galactose.

[0071] In one embodiment, the present disclosure provides a pharmaceutical composition comprising an antigen having a molecular weight of about 167 kilodaltons, for example, between 157 and 177 kilodaltons. In one embodiment, the molecular weight is measured by a method using a superimposed 12-column calibrated with a dextran standard having a molecular weight between 1 kilodalton and 512 kilodaltons.

[0072] B. Testing of relative potency The unit titer according to this disclosure is defined by the relative titer (RP) compared to a reference standard Candida albicans extract. Compounds quantified to have a relative titer of 1 compared to the standard are assigned to have a unit titer of 1 per 1 mL. The relative titer is quantified in a female IAF hairless guinea pig (Crl:HA-HO) model and compared to a reference Candida albicans extract capable of inducing a 5 mm or greater induration reaction in immunocompetent humans 48 hours after a 0.1 mL injection. In one embodiment, the reference standard is established by skin test titration in humans with delayed-type hypersensitivity to Candida albicans.

[0073] Female IAF hairless guinea pigs are selected to be as uniform in age and weight as possible. In one embodiment, no more than 20 female IAF hairless guinea pigs may be used in the study. The hairless guinea pigs are generally 4–6 months old and weigh approximately 0.6–0.8 kilograms at the start of treatment. All experimental animals are acclimated to the designated housing at least 14 days prior to the first day of use.

[0074] In week 0, all experimental animals are sensitized with a 1:1 mixture of complete Freund's adjuvant (CFA) mixed with the antigen solution. In one embodiment, the antigen solution is a 10-fold dilution of the Candida albicans standard extract using unstorable saline. In another embodiment, the antigen solution may be a 100-fold dilution of the Candida albicans standard extract using unstorable saline. In one embodiment, Adjulite CFA (Pacific Immunology) or any other commercially available CFA may be used in this assay. The animals are injected subcutaneously with a needle in up to four doses of 0.1 ml each (i.e., a total of 0.4 ml) of the prepared mixture. In one embodiment, the needle may be a 21 g, 22 g, or 23 g needle. These injections may be administered to the cervical region (either the nape or the entire shoulder), the buttocks (up to two doses at each location, once on each side), and / or the inguinal region (up to 0.1 mL may be administered to each inguinal region). Any one injection regimen, including CFA, can be applied to each guinea pig in the study.

[0075] At 4±1 weeks, four serial dilutions of each test sample and standard substance are prepared separately in phenolized saline. For example, sets of serial dilutions can be prepared in 1:1, 1:4, 1:16, and 1:64 ratios. To ensure proper placement, animals are sedated for intradermal injection. Injections are administered in a volume of 0.1 mL using a 27 g intradermal bevel needle on the back of the sensitized guinea pig. Injection sites are separated at least 3 cm apart on a grid on the guinea pig's back. For example, four “tracks” can be drawn on the guinea pig's back for injections of the standard substance (track 1) and the three test samples (tracks 2-4). Each “track” can be positioned so that the dilution increases from the last diluted (located near the skull) to the most diluted (located near the tail), and all “tracks” are parallel to the spine. See Figure 5 for an example of a track grid on the guinea pig's back.

[0076] At 24 hours ± 4 hours after injection, the animal is manually restrained, the induration is marked, and measurements are taken using a modified Mantot procedure: using a ruler, the longest possible diameter (mm) of the indurated area and its midpoint perpendicular diameter (mm) are recorded. The response at each test site is quantified by averaging the longest and perpendicular axis measurements. Alternatively, a caliper may be used. Optionally, the above measurements can be repeated at 48 hours ± 4 hours.

[0077] In one embodiment, for each guinea pig, the responses of tracks 2, 3, and 4 to track 1 are plotted against their corresponding dilutions and analyzed using the parallel line method. First, the response data for Track 2 and Track 1 against the logarithm (dilution) are plotted on the same graph to test the linearity of the response in the data for each track, and then the parallelism of the two lines is tested. If the two lines are parallel, RP2 is calculated using the following equation.

number

[0078] In one embodiment, for each guinea pig, the responses of tracks 2, 3, and 4 to track 1 are plotted against their corresponding dilutions and analyzed using the gradient ratio method. First, the response data for track 2 and track 1 to dilution are plotted on the same graph, and the linearity of the response in the data for each track is tested using the regression model E(Y)=α+βD. In the equation, α represents the common Y-intercept shared by the two plots, and β t indicates the gradient of the test track (e.g., track 2), and β r∇ t Estimated value of ) / (β r This is calculated as an estimate of ). The same calculation is repeated for tracks 3 and 4 relative to track 1 to obtain RP3 and RP4, respectively, and in this case, α2 is replaced with α3 or α4 and the same formula as above is used.

[0079] After obtaining RP2, RP3, and RP4, plot them against the RP of track 1. Perform regression analysis and R 2 The coefficient of determination shown is obtained. 2 The target value is 0.85 or higher. RP2, RP3, and RP4 are the relative titers of each sample in that track.

[0080] A relative titer of 1 indicates that the titer of the test sample is equal to that of the reference standard.

[0081] C. Formulations One or more components of the pharmaceutical compositions of this disclosure can be formulated by mixing with conventional excipients, carriers, buffers, etc. In one embodiment, the excipient is a substance formulated together with the active ingredient of the pharmaceutical. Typical carriers include, but are not limited to, water; salt solutions; alcohol; gum arabic; vegetable oil; benzyl alcohol; polyethylene glycol; gelatin; carbohydrates, such as lactose, amylose, or starch; magnesium stearate; talc; silicic acid; paraffin; fragrance oils; fatty acid esters; hydroxymethylcellulose; and polyvinylpyrrolidone. In one embodiment, the carrier may include any solvent, dispersion medium, antibacterial and antifungal agents, isotonic and absorption retarders, etc.

[0082] One or more components of the pharmaceutical compositions of this disclosure may be sterilized and may be mixed with auxiliary agents, if desired, such as lubricants; preservatives; disintegrants; stabilizers, such as cyclodextrins; humectants; emulsifiers; salts; buffers; natural or artificial colorants; natural or artificial flavorings; or aromatic substances.

[0083] One or more components of the pharmaceutical compositions of this disclosure may also include one or more of the following agents: acetylated monoglycerides, aspartame, beta-carotene, calcium stearate, carnauba wax, cellulose phthalate acetate, citric acid, anhydrous citric acid, colloidal silicon dioxide, powdered sugar, crospovidone, sodium doxate, ethyl alcohol, ferric oxide, fructose, gelatin, glycerin, glyceryl monostearate (e.g., glyceryl monostearate 40-50), glyceryl triacetate, HPMC (hydroxypropyl methylcellulose), hydroxypropylcellulose, hypromellose, iron oxide, isopropyl alcohol, lactose monohydrate, low-substituted hydroxypropylcellulose, magnesium carbonate, etc. Magnesium thearate, maltol, mannitol, methacrylic acid, methacrylic acid copolymer (e.g., methacrylic acid copolymer type C), methylcellulose, microcrystalline cellulose, monoammonium glycyrrhizinate, n-butyl alcohol, paraffin, propylene glycol pectin alginate, polyacrylate, polyethylene glycol (e.g., polyethylene glycol 6000), polysorbate 80, polyvinylpyrrolidone, povidone, propylene glycol, shellac, silicon dioxide, sodium carbonate, sodium citrate, sodium hydroxide, sodium lauryl sulfate, sodium stearyl fumarate, sorbitol, starch, sucrose, spheroidal sugars, talc, titanium dioxide, triethyl citrate, and xanthan gum.

[0084] In one embodiment, the pharmaceutical compositions described herein comprise an active compound prepared for administration as an aqueous solution of a free base or a pharmaceutically acceptable salt appropriately mixed with a surfactant such as hydroxypropylcellulose. The pharmaceutically acceptable base addition salt can be formed using a metal or amine, such as alkali metals and alkaline earth metals, or an organic amine. The pharmaceutically acceptable salt of the compound can also be prepared using a pharmaceutically acceptable cation. Suitable pharmaceutically acceptable cations are well known to those skilled in the art and include alkali cations, alkaline earth cations, ammonium cations, and quaternary ammonium cations. Carbonates or bicarbonates are also possible. Examples of metals used as cations include sodium, potassium, magnesium, ammonium, calcium, or ferric iron. Examples of suitable amines include isopropylamine, trimethylamine, histidine, N,N'-dibenzylethylenediamine, chloroprocaine, choline, diethanolamine, dicyclohexylamine, ethylenediamine, N-methylglucamine, and procaine.

[0085] Medicinally acceptable acid addition salts include inorganic or organic acid salts. Examples of suitable acid salts include hydrochloride, acetate, citrate, salicylate, nitrate, and phosphate. Other suitable pharmaceutically acceptable salts are well known to those skilled in the art, and include, for example, acetic acid, citric acid, oxalic acid, tartaric acid, or mandelic acid, hydrochloric acid, hydrobromic acid, sulfuric acid, or phosphoric acid; organic carboxylic acids, sulfonic acids, sulfoacids or phosphoacids, or N-substituted sulfamic acids, such as acetic acid, propionic acid, glycolic acid, succinic acid, maleic acid, hydroxymaleic acid, methylmaleic acid, fumaric acid, malic acid, tartaric acid, lactic acid, oxalic acid, gluconic acid, glucaric acid, glucuronic acid, citric acid, benzoic acid, cinnamic acid, mandelic acid, salicylic acid, 4-aminosalicylic acid, 2-phenoxybenzoic acid, 2-acetoxybenzoic acid, and ethanol. Examples include phenylacetic acid, nicotinic acid, or isonicotinic acid; amino acids, such as the 20 α-amino acids involved in the synthesis of natural proteins, such as glutamic acid or aspartic acid; as well as phenylacetic acid, methanesulfonic acid, ethanesulfonic acid, 2-hydroxyethanesulfonic acid, ethane-1,2-disulfonic acid, benzenesulfonic acid, 4-methylbenzenesulfonic acid, naphthalene-2-sulfonic acid, naphthalene-1,5-disulfonic acid, 2 or 3-phosphoglyceric acid, glucose-6-phosphate, N-cyclohexylsulfamic acid (with cyclamate formation); or other acidic organic compounds, such as salts with ascorbic acid.

[0086] In one embodiment, the pharmaceutical composition of the Disclosure comprises NaCl, NaHCO3, human albumin, polysorbate 80, and phenol. In one embodiment, the pharmaceutical composition of the Disclosure comprises 0.5% NaCl, 0.25% NaHCO3, 0.03% human albumin, 8 ppm polysorbate 80, and 0.4% phenol.

[0087] In one embodiment, the pharmaceutical compositions of the present disclosure described herein can be administered to a subject requiring the pharmaceutical composition via any route, such routes include, but are not limited to, sublingual, sacral, dental, intracervical, enteral, epidural, extracorporeal, intravenous, transplantation, infiltration, intraamniotic, intraarterial, intraarticular, intrabuccal, intracardiac, intrasacral, intracavitary, intradermal, intradiscal, intrafocal, intralymphatic, intraocular, intraperitoneal, intrapleural, intravertebral, synovial, intramedullary, intratracheal, intratumoral, intratympanic, intrauterine, intravascular, intravitreous, iontophoresis, irrigation, transnasal, parenteral, percutaneous, periarticular, peridural, periodontal, photophoresis, retrobulbar, subarachnoid, subconjunctival, submucosal, percutaneous, ureter, and urethral. In one embodiment, the pharmaceutical composition of this disclosure is administered intrafocally to a subject requiring the pharmaceutical composition. In one embodiment, administration is carried out by introducing the dosage form into the system of the subject requiring treatment.

[0088] In one embodiment, the pharmaceutical compositions of the Disclosure described herein may be administered by means of a form selected from the group consisting of oral, buccal, sublingual, topical, injection, infusion, inhalation, transrectal, intravenous, intramuscular, and subcutaneous forms. For example, the pharmaceutical compositions of the Disclosure described herein may be administered by means of a transdermal patch, by microneedle, as a mist, as a suppository, as a gel, as a cream, as a pill, or as a spray using methods known in the art. In one embodiment, the pharmaceutical compositions of the Disclosure described herein may be administered by means of injection.

[0089] The pharmaceutical compositions provided herein can be prepared as pharmaceutical forms suitable for injection. In one embodiment, such compositions include sterile aqueous solutions or dispersions, and sterile powders for the immediate preparation of sterile injection solutions or dispersions. In all cases, the form must be sterile and fluid insofar as it ensures ease of injection. The form must be stable under manufacturing and storage conditions and protected from contamination by microorganisms such as bacteria and fungi. The carrier may be a solvent or a dispersion medium, and may contain, for example, water, ethanol, polyols (e.g., glycerol, propylene glycol, and liquid polyethylene glycol), suitable mixtures thereof, and vegetable oils. In one embodiment, the solvent is a pharmaceutically acceptable solvate. Adequate fluidity can be maintained, for example, by the use of coatings such as lecithin, maintaining the required particle size when dispersed, and by the use of surfactants. Microbial action can be prevented by various antimicrobial and antifungal agents, such as parabens, chlorobutanol, phenol, sorbic acid, and thimerosal. In many cases, it is preferable to include an isotonic agent (e.g., sugar or sodium chloride). The injectable composition can be absorbed continuously by using a composition of substances that slow down absorption, such as aluminum monostearate and gelatin.

[0090] In one embodiment, a sterile injection solution is prepared by incorporating the required amount of the active compound, along with various other components listed above as needed, into a suitable solvent, and then sterilizing by filtration. Generally, dispersions are prepared by incorporating various sterilized active ingredients into a sterile vehicle containing a basic dispersion medium and other components listed above as needed. For sterile powders for preparing sterile injection solutions, preferred preparation methods are vacuum drying and lyophilization techniques, which yield a powder containing the active ingredient and any additional desired components from a pre-sterilized filtered solution.

[0091] In one embodiment, the pharmaceutical composition disclosed herein comprises human serum albumin. In one embodiment, the pharmaceutical composition disclosed herein comprises polysorbate 80.

[0092] In one embodiment, the pharmaceutical composition disclosed herein can be formulated as a sterile stabilized filtration extract of Candida albicans. In one embodiment, the pharmaceutical composition can be formulated in a single-dose vial. In one embodiment, the pharmaceutical composition can be formulated in a single non-storage vial. In one embodiment, the pharmaceutical composition can be formulated in a multi-dose vial. In one embodiment, the pharmaceutical composition can be formulated in a multi-dose storage vial. In one embodiment, the pharmaceutical composition can be formulated as a pre-filled syringe or device, with or without an attached needle. In one embodiment, the pharmaceutical composition can be formulated in a container selected from the group consisting of needles, vials, and ampoules. In one embodiment, the container can be a glass container or a plastic container. In one embodiment, the container has a volume of approximately 0.25 ml, approximately 0.5 ml, approximately 0.75 ml, approximately 1.0 ml, approximately 1.5 ml, approximately 2.0 ml, approximately 2.5 ml, approximately 3.0 ml, approximately 3.5 ml, approximately 4.0 ml, approximately 4.5 ml, approximately 5 ml, approximately 6 ml, approximately 7 ml, approximately 8 ml, approximately 9 ml, or approximately 10 ml.

[0093] In one embodiment, a pharmaceutical product comprising Candida albicans and a filtered extract of the secretory antigen is provided in cumulative doses provided herein for use in the treatment of warts according to this disclosure. In one embodiment, the treatment of warts is selected from the group consisting of complete disappearance of common warts, partial disappearance of common warts, reduction in the diameter of common warts, partial disappearance of multiple common warts, reduction of the diameter of multiple common warts by at least 50%, complete disappearance of non-common warts, complete disappearance of previously treated common warts, and delayed reappearance of common warts at the time of disappearance. In one embodiment, the drug provides treatment for warts at cumulative doses of less than approximately 0.5 unit potency, less than approximately 1 unit potency, less than approximately 2 unit potency, less than approximately 3 unit potency, less than approximately 4 unit potency, less than approximately 5 unit potency, less than approximately 6 unit potency, less than approximately 7 unit potency, less than approximately 8 unit potency, less than approximately 9 unit potency, or less than approximately 10 unit potency. In one embodiment, the drug is formulated for administration to a subject by injection. In one embodiment, the injection is provided as an intra-focal injection.

[0094] In one embodiment, a pharmaceutical product is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely eliminate verruca vulgaris at a cumulative dose of 2.5 unit potency. In one embodiment, the Disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely eliminate verruca vulgaris at a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0095] In one embodiment, a pharmaceutical product is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially clear common warts at a cumulative dose of 5 unit potency. In one embodiment, the Disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially clear common warts at a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0096] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of a common wart by at least 50% in a cumulative dose of 1 unit potency. In one embodiment, the Disclosure provides a pharmaceutical comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of a common wart by at least 50% in a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0097] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially clear multiple verruca vulgaris at a cumulative dose of 5 unit potency. In one embodiment, the Disclosure provides a pharmaceutical comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially clear multiple verruca vulgaris at a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0098] In one embodiment, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of multiple verruca vulgaris by at least 50% in a cumulative dose of 1 unit potency. In one embodiment, the present disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of multiple verruca vulgaris by at least 50% in a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0099] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely eliminate non-common warts at a cumulative dose of 5 unit potency. In one embodiment, the Disclosure provides a pharmaceutical comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely eliminate non-common warts at a cumulative dose of less than about 0.5 unit potency, less than about 1 unit potency, less than about 2 unit potency, less than about 3 unit potency, less than about 4 unit potency, less than about 5 unit potency, less than about 6 unit potency, less than about 7 unit potency, less than about 8 unit potency, less than about 9 unit potency, or less than about 10 unit potency.

[0100] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely clear previously treated verruca vulgaris at a cumulative dose of 5 units potency. In one embodiment, the Disclosure provides a pharmaceutical comprising a filtered extract of Candida albicans and a secretory antigen, formulated to completely clear previously treated verruca vulgaris at a cumulative dose of less than about 0.5 units potency, less than about 1 unit potency, less than about 2 units potency, less than about 3 units potency, less than about 4 units potency, less than about 5 units potency, less than about 6 units potency, less than about 7 units potency, less than about 8 units potency, less than 9 units potency, or less than 10 units potency.

[0101] In one embodiment, a pharmaceutical product is provided comprising a filtered extract of Candida albicans and a secretory antigen, formulated in a cumulative dose of 2.5 units potency to delay the reappearance of verruca vulgaris upon the disappearance of verruca vulgaris. In one embodiment, the Disclosure provides a pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated in a cumulative dose of less than about 0.5 units potency, less than about 1 unit potency, less than about 2 units potency, less than about 3 units potency, less than about 4 units potency, less than about 5 units potency, less than about 6 units potency, less than about 7 units potency, less than about 8 units potency, less than 9 units potency, or less than about 10 units potency to delay the reappearance of verruca vulgaris upon the disappearance of verruca vulgaris.

[0102] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and secretory antigens, used to reduce the levels of cytokine biomarkers in subjects diagnosed with verruca vulgaris. In one embodiment, the cytokine biomarkers are inflammatory cytokines. In one embodiment, the cytokine biomarkers are selected from the group consisting of IL-23, IL-7, and IP-10. In one embodiment, the levels of cytokine biomarkers in subjects are reduced upon administration of the pharmaceutical comprising the filtered extract of Candida albicans and secretory antigens at cumulative doses of less than approximately 0.5 unit titers, less than approximately 1 unit titer, less than approximately 2 unit titers, less than approximately 3 unit titers, less than approximately 4 unit titers, less than approximately 5 unit titers, less than approximately 6 unit titers, less than approximately 7 unit titers, less than approximately 8 unit titers, less than approximately 9 unit titers, or less than approximately 10 unit titers. In one embodiment, the levels of cytokine biomarkers in a subject decrease when a drug containing filtered extracts of Candida albicans and secretory antigens is administered at cumulative doses of at least about 0.5 unit titers, at least about 1 unit titer, at least about 2 unit titers, at least about 3 unit titers, at least about 4 unit titers, at least about 5 unit titers, at least about 6 unit titers, at least about 7 unit titers, at least about 8 unit titers, at least about 9 unit titers, or at least about 10 unit titers. In one embodiment, the levels of cytokine biomarkers in a subject decrease when a drug containing filtered extracts of Candida albicans and secretory antigens is administered at cumulative doses of at least about 0.5 unit titers to 10 unit titers, for example, 0.5 unit titers to 9.5 unit titers, about 1 unit titer to 9.5 unit titers, about 1.5 unit titers to about 9 unit titers, about 2 unit titers to about 9 unit titers, about 2 unit titers to about 8.5 unit titers, about 2.5 unit titers to about 8.5 unit titers, and about 2.5 unit titers to about 8 unit titers. When a pharmaceutical product containing filtered extracts of Candida albicans and secretory antigens is administered at cumulative doses of approximately 3 to 8 units, 3 to 7.5 units, 3.5 to 7.5 units, 3.5 to 7 units, 4 to 7 units, 4 to 6.5 units, 4.5 to 6.5 units, 4.5 to 6 units, or 5 to 6 units, the titer decreases.In one embodiment, the levels of cytokine biomarkers decrease by up to 99.9% in a subject upon administration of one cumulative dose of the drug, for example, up to 99.5%, up to 99%, up to 98%, up to 95%, up to 90%, up to 85%, up to 80%, up to 75%, up to 70%, up to 65%, up to 60%, up to 55%, up to 50%, up to 45%, up to 40%, up to 35%, up to 30%, up to 25%, up to 20%, up to 15%, up to 10%, or up to 5%. In one embodiment, the levels of cytokine biomarkers decrease by approximately 5% to approximately 99.9% in a subject upon administration of one cumulative dose of the drug, for example, from approximately 5% to approximately 99.8%, 5% to approximately 99.5%, 5% to approximately 99%, 5% to approximately 98%, 5% to approximately 95%, 10% to approximately 95%, 10% to approximately 90%, and 15% to approximately 90%. It decreases by approximately 15% to 85%, 20% to 85%, 20% to 80%, 25% to 80%, 25% to 75%, 30% to 75%, 30% to 70%, 35% to 70%, 35% to 65%, 40% to 65%, 40% to 60%, 45% to 60%, 45% to 55%, or 50% to 55%.

[0103] In one embodiment, a pharmaceutical product is provided comprising Candida albicans and a filtered extract of a secretory antigen, used to reduce the level of IL-23 in a subject requiring a reduction in the level of IL-23. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0104] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, used to completely eliminate verruca vulgaris in a subject requiring complete elimination of verruca vulgaris by reducing the level of IL-23 by at least about 35% in such subject. In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, used to completely eliminate verruca vulgaris in a subject requiring complete elimination of verruca vulgaris by reducing the level of IL-23 by at least about 15% in such subject.

[0105] In one embodiment, a pharmaceutical product is provided comprising Candida albicans and a filtered extract of a secretory antigen, used to reduce the level of IL-7 in a subject requiring a reduction in the level of IL-7. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0106] In one embodiment, a pharmaceutical product is provided comprising Candida albicans and a filtered extract of a secretory antigen, used to reduce the level of IP-10 in a subject requiring a reduction in the level of IP-10. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris.

[0107] In one embodiment, a pharmaceutical product is provided for use in the complete elimination of common warts, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and their secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0108] In one embodiment, a pharmaceutical product is provided for use in the partial disappearance of common warts, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0109] In one embodiment, a pharmaceutical product is provided for use in reducing the diameter of common warts by at least 50%, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0110] In one embodiment, a pharmaceutical product is provided for use in the partial disappearance of multiple common warts, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0111] In one embodiment, a pharmaceutical product is provided for use in reducing the diameter of multiple common warts by at least 50%, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0112] In one embodiment, a pharmaceutical product is provided for use in the complete elimination of non-verruca vulgaris, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and their secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0113] In one embodiment, a pharmaceutical product is provided for use in the complete elimination of previously treated common warts, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and their secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0114] In one embodiment, a pharmaceutical product is provided for use in delaying the reappearance of common warts, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and their secretory antigens, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0115] In one embodiment, a pharmaceutical product is provided comprising a filtered extract of Candida albicans and a secretory antigen, to be used to reduce the level of IL-23 in a subject requiring a reduction in the level of IL-23, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and a secretory antigen, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, the subject is diagnosed with having at least one common verruca vulgaris. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0116] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, used to completely eliminate common warts in subjects requiring complete elimination of said common warts, the pharmaceutical achieving complete elimination of said common warts by reducing the level of IL-23 in the subject requiring said elimination by at least about 35%, wherein the pharmaceutical comprises filtered extracts of two strains of Candida albicans and a secretory antigen, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0117] In one embodiment, a pharmaceutical product is provided, comprising a filtered extract of Candida albicans and a secretory antigen, for use in a subject requiring a reduction in IL-7 levels, wherein the pharmaceutical product comprises filtered extracts of two strains of Candida albicans and a secretory antigen, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, the subject is diagnosed with having at least one common verruca. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0118] In one embodiment, a pharmaceutical is provided comprising a filtered extract of Candida albicans and a secretory antigen, used to reduce the level of IP-10 in a subject requiring a reduction in IP-10 levels, wherein the pharmaceutical comprises filtered extracts of two strains of Candida albicans and a secretory antigen, a representative sample of the first strain deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, the subject is diagnosed with having at least one common verruca. In one embodiment, a representative sample of the first strain deposited with ATCC under ATCC accession number ATCC-10231.

[0119] In one embodiment, a pharmaceutical product comprising Candida albicans and a filtered extract of the secretory antigen is formulated to have at least 1 unit potency per ml, for example, at least about 2 unit potencies per ml, at least about 3 unit potencies per ml, at least about 4 unit potencies per ml, at least about 5 unit potencies per ml, at least about 6 unit potencies per ml, at least about 7 unit potencies per ml, at least about 8 unit potencies per ml, at least about 9 unit potencies per ml, at least about 10 unit potencies per ml, at least about 15 unit potencies per ml, and at least The formulation is designed to have a potency of approximately 20 units, at least approximately 25 units per ml, at least approximately 30 units per ml, at least approximately 40 units per ml, at least approximately 50 units per ml, at least approximately 30 units per ml, at least approximately 40 units per ml, at least approximately 50 units per ml, at least approximately 60 units per ml, at least approximately 70 units per ml, at least approximately 80 units per ml, at least approximately 90 units per ml, or at least approximately 100 units per ml.

[0120] D. Treatment method In one embodiment, a method is provided for treating warts in a subject requiring treatment for warts, the method comprising administering one or more doses of the pharmaceutical composition of the Disclosure to the subject requiring treatment. In one embodiment, the proliferation on the skin is caused by human papillomavirus. In one embodiment, the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the method of the Disclosure completely or partially suppresses the development of warts. In one embodiment, the method of the Disclosure completely or partially reduces warts. In one embodiment, the method of the Disclosure causes regression of warts. In one embodiment, the method of the Disclosure completely or partially prevents the development of warts in a patient who is susceptible to developing warts. In one embodiment, treatment of warts is selected from the group consisting of complete disappearance of common warts, partial disappearance of common warts, reduction in the diameter of common warts, partial disappearance of multiple common warts, reduction of the diameter of multiple common warts by at least 50%, complete disappearance of non-common warts, complete disappearance of previously treated common warts, and delay in the reappearance of common warts at the time of disappearance. In one embodiment, the method for treating warts achieves its treatment goal with a cumulative dose of less than approximately 0.5 units of potency, less than approximately 1 unit of potency, less than approximately 2 units of potency, less than approximately 3 units of potency, less than approximately 4 units of potency, less than approximately 5 units of potency, less than approximately 6 units of potency, less than approximately 7 units of potency, less than approximately 8 units of potency, less than approximately 9 units of potency, or less than approximately 10 units of potency. In one embodiment, each dose is administered to the subject by injection. In one embodiment, the injection is provided as an intra-lesional injection.

[0121] In one embodiment, a method is provided for treating common warts in a subject requiring treatment for said warts, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 units potency, in an amount effective for the complete disappearance of said warts, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0122] In one embodiment, complete disappearance of common warts is identified by observation at least 20 weeks after administration of the first intralesional injection, for example, at approximately 20 weeks, 25 weeks, 30 weeks, 35 weeks, 40 weeks, 45 weeks, 50 weeks, 55 weeks, 60 weeks, 70 weeks, 80 weeks, 90 weeks, or 100 weeks after administration of the first intralesional injection, when no common warts recur at the same site. In one embodiment, recurrence of common warts is defined by the growth of warts at the same location where previously regressed warts existed.

[0123] In one embodiment, complete disappearance of a wart is accompanied by the absence of scarring at the location of the common wart. In one embodiment, complete disappearance of warts is accompanied by a low level of depigmentation at the site of the common warts (e.g., less than 3% of all disappeared common warts).

[0124] In one embodiment, a method is provided for treating verruca vulgaris in a subject requiring treatment of said verruca vulgaris, the method comprising administering to the subject one or more intra-focal injections of a pharmaceutical composition effective for partial disappearance of the verruca vulgaris in a cumulative dose of 5 units potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the pharmaceutical composition effective for partial disappearance of verruca vulgaris in a cumulative dose of 5 units potency is also effective for reducing the diameter of the verruca vulgaris by at least 50% in a cumulative dose of 1 unit potency. In one embodiment, partial disappearance of the verruca is identified by an arbitrary reduction in the diameter of the verruca compared to the diameter observed before the first intra-focal injection.

[0125] In one embodiment, a method is provided for treating verruca vulgaris in a subject requiring treatment of said verruca vulgaris, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in an amount capable of partial disappearance of the verruca vulgaris at a cumulative dose of 5 units potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, a pharmaceutical composition effective for partial disappearance of verruca vulgaris at a cumulative dose of 5 units potency may also reduce the diameter of the verruca vulgaris by at least 50% at a cumulative dose of 1 unit potency.

[0126] In one embodiment, a method is provided for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial disappearance of said multiple verruca vulgaris, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

[0127] In one embodiment, a method is provided for treating a plurality of verruca vulgaris in a subject requiring treatment of said plurality of verruca vulgaris, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in an amount effective in reducing the diameter of each of the plurality of verruca vulgaris by at least 50% in a cumulative dose of 1 unit potency, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

[0128] In one embodiment, multiple verrucae include 2 to 20 verrucae, for example, 2 to 20 verrucae, 2 to 19 verrucae, 3 to 19 verrucae, 3 to 18 verrucae, 4 to 18 verrucae, 4 to 17 verrucae, 5 to 17 verrucae, 5 to 16 verrucae, 6 to 1 The present invention includes 6 common warts, 6–15 common warts, 7–15 common warts, 7–14 common warts, 8–14 common warts, 8–13 common warts, 9–13 common warts, 9–12 common warts, 10–12 common warts, 10–11 common warts, or 11–12 common warts. In one embodiment, the multiple common warts are located in the same anatomical location on the subject. In one embodiment, the multiple common warts are located in different anatomical locations on the subject. In one embodiment, the anatomical location is selected from one of the following regions of the subject's body: left arm, right arm, left hand, right hand, left lower limb, right lower limb, left foot, right foot, and torso. In one embodiment, the arm region includes the shoulder, upper arm and forearm, wrist, and half of the axilla. In one embodiment, the hand region begins distal to the wrist, excluding periungual warts. In one embodiment, the foot begins distal to the ankle, excluding the sole. In one embodiment, the lower limb region includes the upper leg, lower leg, and ankle. In one embodiment, the torso region includes the neck, back, chest, abdomen, buttocks, and pelvic region.

[0129] In one embodiment, a method is provided for treating non-common warts in a subject requiring treatment for non-common warts and having one or more common warts, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for the complete disappearance of the non-common warts, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

[0130] In one embodiment, a non-common wart is a plantar wart. In one embodiment, a non-common wart is a genital wart. In one embodiment, a non-common wart is a facial wart. In one embodiment, a non-common wart is a flat wart. In one embodiment, a non-common wart is a perinatal wart. In one embodiment, a non-common wart is located in the same anatomical region as one or more common warts.

[0131] In one embodiment, complete disappearance of non-vulgaris verruca is identified by observation at least 20 weeks after administration of the first intralesional injection, for example, at approximately 20 weeks, 25 weeks, 30 weeks, 35 weeks, 40 weeks, 45 weeks, 50 weeks, 55 weeks, 60 weeks, 70 weeks, 80 weeks, 90 weeks, or 100 weeks after administration of the first intralesional injection, when no non-vulgaris verruca recurrence occurs at the same site. In one embodiment, recurrence of a common verruca is defined by the growth of a verruca at the same location where a previously regressed verruca existed.

[0132] In one embodiment, a method is provided for treating previously treated verruca vulgaris in a subject requiring treatment of said previously treated verruca vulgaris, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for complete clearance of said previously treated verruca vulgaris, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

[0133] In one embodiment, previously treated verruca vulgaris is verruca vulgaris that was previously treated with cryotherapy. In one embodiment, previously treated verruca vulgaris did not respond to cryotherapy. In one embodiment, cryotherapy did not completely eliminate previously treated verruca vulgaris.

[0134] In one embodiment, previously treated verruca vulgaris is verruca vulgaris that was previously treated with salicylic acid or a related acid. In one embodiment, the related acid is trichloroacetic acid or bichloroacetic acid. In one embodiment, previously treated verruca vulgaris did not respond to salicylic acid or a related acid. In one embodiment, salicylic acid or a related acid did not completely eliminate previously treated verruca vulgaris.

[0135] In one embodiment, previously treated verruca vulgaris is verruca vulgaris that has been previously treated with a treatment selected from the group consisting of liquid nitrogen, carbon dioxide, cantharidin, simple occlusion, verruca gel, apple cider vinegar, surgery, laser, tea tree oil, cryotherapy verruca spray, verruca curettage, electrocautery, lavender and oregano essential oils, and imiquimod. In one embodiment, previously treated verruca vulgaris did not respond to prior treatment. In one embodiment, prior treatment did not completely eliminate previously treated verruca vulgaris.

[0136] In one embodiment, complete disappearance of previously treated common warts is identified by observation at least 20 weeks after administration of the first intralesional injection, for example, at approximately 20 weeks, 25 weeks, 30 weeks, 35 weeks, 40 weeks, 45 weeks, 50 weeks, 55 weeks, 60 weeks, 70 weeks, 80 weeks, 90 weeks, or 100 weeks after administration of the first intralesional injection, when no previously treated common warts recur at the same site. In one embodiment, recurrence of common warts is defined by the growth of warts at the same location where previously regressed warts existed.

[0137] In one embodiment, complete disappearance of previously treated common warts is accompanied by the absence of scarring at the site of the warts. In one embodiment, complete disappearance of previously treated common warts is accompanied by a low level of depigmentation at the site of the warts (e.g., less than 3% of all disappeared warts).

[0138] In one embodiment, a method is provided for delaying the recurrence of common warts in a subject requiring delay in the recurrence of said common warts, the method comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 units potency, in an amount effective in delaying the reappearance of said common warts upon disappearance, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, delaying the reappearance of verruca vulgaris means postponing, interfering with, slowing, delaying, stabilizing, and / or postponing the onset of the condition at the same location where previously regressed verrucae were present. In one embodiment, the length of time of the delay may vary depending on the history of the condition and / or the individual being treated. In one embodiment, the subject will not develop any new verruca vulgaris within at least 16 weeks after the last injection of the treatment regimen, for example, at least 18 weeks, at least 20 weeks, at least 25 weeks, at least 30 weeks, at least 35 weeks, at least 40 weeks, at least 45 weeks, at least 50 weeks, at least 55 weeks, at least 60 weeks, at least 65 weeks, at least 70 weeks, at least 80 weeks, at least 90 weeks, or at least 100 weeks after the last injection of the treatment regimen. In one embodiment, the subject does not develop any new verruca vulgaris within the same anatomical region where the verruca vulgaris disappeared. In another embodiment, the subject does not develop any new verruca vulgaris in the same location as the verruca vulgaris that disappeared.

[0139] In one embodiment, a method is provided for reducing the level of a cytokine biomarker in a subject requiring a reduction in the level of said cytokine biomarker, the method comprising administering to the subject one or more intralesional injections of one volume of a pharmaceutical composition in a cumulative dose of about 0.5 to about 10 units of potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the cytokine biomarker is an inflammatory cytokine. In one embodiment, the subject is diagnosed with having at least one common wart. In one embodiment, the cytokine biomarker is selected from the group consisting of IL-23, IL-7, and IP-10. In one embodiment, the level of cytokine biomarkers in a subject decreases when the pharmaceutical composition of the Disclosure is administered at a cumulative dose of less than approximately 0.5 unit potency, less than approximately 1 unit potency, less than approximately 2 unit potency, less than approximately 3 unit potency, less than approximately 4 unit potency, less than approximately 5 unit potency, less than approximately 6 unit potency, less than approximately 7 unit potency, less than approximately 8 unit potency, less than approximately 9 unit potency, or less than approximately 10 unit potency. In one embodiment, the level of cytokine biomarkers in a subject decreases when the pharmaceutical composition of the Disclosure is administered at a cumulative dose of at least approximately 0.5 unit potency, at least approximately 1 unit potency, at least approximately 2 unit potency, at least approximately 3 unit potency, at least approximately 4 unit potency, at least approximately 5 unit potency, at least approximately 6 unit potency, at least approximately 7 unit potency, at least approximately 8 unit potency, at least approximately 9 unit potency, or at least approximately 10 unit potency.In one embodiment, the level of cytokine biomarkers in the subject is approximately 0.5 to 10 units potency at cumulative doses, for example, approximately 0.5 to 9.5 units potency, approximately 1 to 9.5 units potency, approximately 1.5 to 9 units potency, approximately 2 to 9 units potency, approximately 2 to 8.5 units potency, approximately 2.5 to 8.5 units potency, and approximately 2.5 to 8 units potency. When the pharmaceutical composition of this disclosure is administered in cumulative doses of approximately 3 to 8 units potency, approximately 3 to 7.5 units potency, approximately 3.5 to 7.5 units potency, approximately 3.5 to 7.5 units potency, approximately 4 to 7 units potency, approximately 4 to 6.5 units potency, approximately 4.5 to 6.5 units potency, approximately 4.5 to 6 units potency, or approximately 5 to 6 units potency, the titer decreases. In one embodiment, the level of a cytokine biomarker decreases by up to 99.9% in a subject upon administration of one cumulative dose of the pharmaceutical composition of the present disclosure, for example, up to 99.5%, up to 99%, up to 98%, up to 95%, up to 90%, up to 85%, up to 80%, up to 75%, up to 70%, up to 65%, up to 60%, up to 55%, up to 50%, up to 45%, up to 40%, up to 35%, up to 30%, up to 25%, up to 20%, up to 15%, up to 10%, or up to 5%. In one embodiment, the levels of cytokine biomarkers decrease by approximately 5% to approximately 99.9% in a subject upon administration of one cumulative dose of the pharmaceutical composition of the present disclosure, for example, approximately 5% to approximately 99.8%, approximately 5% to approximately 99.5%, approximately 5% to approximately 99%, approximately 5% to approximately 98%, approximately 5% to approximately 95%, approximately 10% to approximately 95%, approximately 10% to approximately 90%, and approximately 15% to approximately It decreases by 90%, approximately 15% to 85%, approximately 20% to 85%, approximately 20% to 80%, approximately 25% to 80%, approximately 25% to 75%, approximately 30% to 75%, approximately 30% to 70%, approximately 35% to 70%, approximately 35% to 65%, approximately 40% to 65%, approximately 40% to 60%, approximately 45% to 60%, approximately 45% to 55%, or approximately 50% to 55%.

[0140] In one embodiment, a method is provided for reducing the level of IL-23 in a subject requiring a reduction in the level of IL-23, the method comprising administering to the subject one or more intrafocal injections of one volume of a pharmaceutical composition in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one common wart. In one embodiment, the method of the disclosure reduces the level of IL-23 in the subject by at least about 15% compared to the level of IL-23 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the disclosure. In one embodiment, the method of the disclosure reduces the level of IL-23 in the subject by at least about 35% compared to the level of IL-23 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the disclosure.

[0141] In one embodiment, a method is provided for the complete elimination of common warts in a subject requiring complete elimination of said common warts, the method comprising reducing the level of IL-23 in the subject requiring complete elimination of said common warts by at least about 35%. In one embodiment, a method is provided for the complete elimination of common warts in a subject requiring complete elimination of said common warts, the method comprising reducing the level of IL-23 in the subject requiring complete elimination of said common warts by at least about 15%. In one embodiment, the method of the present disclosure reduces the level of IL-23 by administering to a subject one or more intralesional injections of one amount of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0142] In one embodiment, a method is provided for reducing the level of IL-7 in a subject requiring a reduction in the level of IL-7, the method comprising administering to the subject one or more intrafocal injections of one volume of a pharmaceutical composition in a cumulative dose of 0.6 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris. In one embodiment, the method of the present disclosure reduces the level of IL-7 in the subject by at least about 10% compared to the level of IL-7 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the present disclosure.

[0143] In one embodiment, a method is provided for reducing the level of IL-7 in a subject requiring a reduction in the level of IL-7, the method comprising administering to the subject one or more intrafocal injections of one volume of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris. In one embodiment, the method of the disclosure reduces the level of IL-7 in the subject by at least about 20% compared to the level of IL-7 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the disclosure.

[0144] In one embodiment, a method is provided for reducing the level of IP-10 in a subject requiring a reduction in the level of IP-10, the method comprising administering to the subject one or more intralesional injections of one volume of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens. In one embodiment, the subject is diagnosed with having at least one verruca vulgaris. In one embodiment, the method of the disclosure reduces the level of IP-10 in the subject by at least about 5% compared to the level of IP-10 measured in the subject prior to the administration step, upon receiving one cumulative dose of the pharmaceutical composition of the disclosure.

[0145] In one embodiment, the method of the disclosure is effective in achieving the treatment objective at cumulative doses of less than approximately 0.5 unit potency, less than approximately 1 unit potency, less than approximately 2 unit potency, less than approximately 3 unit potency, less than approximately 4 unit potency, less than approximately 5 unit potency, less than approximately 6 unit potency, less than approximately 7 unit potency, less than approximately 8 unit potency, less than approximately 9 unit potency, or less than approximately 10 unit potency. In one embodiment, the method of the disclosure can achieve the treatment objective at cumulative doses of less than approximately 0.5 unit potency, less than approximately 1 unit potency, less than approximately 2 unit potency, less than approximately 3 unit potency, less than approximately 4 unit potency, less than approximately 5 unit potency, less than approximately 6 unit potency, less than approximately 7 unit potency, less than approximately 8 unit potency, less than approximately 9 unit potency, or less than approximately 10 unit potency.

[0146] In one embodiment, the method of the present disclosure is effective in achieving a therapeutic objective at a cumulative dose of at least about 0.5 unit potency, at least about 1 unit potency, at least about 2 unit potency, at least about 3 unit potency, at least about 4 unit potency, at least about 5 unit potency, at least about 6 unit potency, at least about 7 unit potency, at least about 8 unit potency, at least about 9 unit potency, or at least about 10 unit potency. In one embodiment, the method of the present disclosure can achieve a therapeutic objective at a cumulative dose of at least about 0.5 unit potency, at least about 1 unit potency, at least about 2 unit potency, at least about 3 unit potency, at least about 4 unit potency, at least about 5 unit potency, at least about 6 unit potency, at least about 7 unit potency, at least about 8 unit potency, at least about 9 unit potency, or at least about 10 unit potency.

[0147] In one embodiment, the method of the present disclosure provides a cumulative dose of about 0.5 unit potency to about 10 unit potency, for example, about 0.5 unit potency to about 9.5 unit potency, about 1 unit potency to about 9.5 unit potency, about 1.5 unit potency to about 9 unit potency, about 2 unit potency to about 9 unit potency, about 2 unit potency to about 8.5 unit potency, about 2.5 unit potency to about 8.5 unit potency, about 2.5 unit potency to about 8 unit potency, and about 3 unit potency. The following cumulative doses are effective in achieving the treatment target: 1 unit potency to approximately 8 unit potency, approximately 3 unit potency to approximately 7.5 unit potency, approximately 3.5 unit potency to approximately 7.5 unit potency, approximately 3.5 unit potency to approximately 7 unit potency, approximately 4 unit potency to approximately 7 unit potency, approximately 4 unit potency to approximately 6.5 unit potency, approximately 4.5 unit potency to approximately 6 unit potency, or approximately 5 unit potency to approximately 6 unit potency. In one embodiment, the method of the present disclosure provides a cumulative dose of about 0.5 unit potency to about 10 unit potency, for example, about 0.5 unit potency to about 9.5 unit potency, about 1 unit potency to about 9.5 unit potency, about 1.5 unit potency to about 9 unit potency, about 2 unit potency to about 9 unit potency, about 2 unit potency to about 8.5 unit potency, about 2.5 unit potency to about 8.5 unit potency, about 2.5 unit potency to about 8 unit potency, and about 3 unit potency. The treatment goal can be achieved with cumulative doses of approximately 8 units potency, 3 to 7.5 units potency, 3.5 to 7.5 units potency, 3.5 to 7 units potency, 4 to 7 units potency, 4 to 6.5 units potency, 4.5 to 6.5 units potency, 4.5 to 6 units potency, or 5 to 6 units potency.

[0148] In one embodiment, each dose administered by the method of the present disclosure may be administered via a form selected from the group consisting of oral, buccal, sublingual, topical, injection, infusion, inhalation, rectal, intravenous, intramuscular, and subcutaneous forms. In one embodiment, two or more intrafocal injections are provided to a subject requiring them over a single time period. In one embodiment, the potency of each dose is at least 0.3 unit potency. In one embodiment, the potency of each dose is at least 0.5 unit potency. In one embodiment, each dose is administered in doses of at least about 0.1 unit potency to about 1 unit potency, for example, about 0.1 unit potency to about 0.9 unit potency, for example, about 0.2 unit potency to about 1 unit potency, for example, about 0.2 unit potency to about 0.8 unit potency, for example, about 0.2 unit potency to about 0.5 unit potency, for example, about 0.2 unit potency to about 0.4 unit potency, for example, about 0.3 unit potency to about 0.7 unit potency, or for example, about 0.4 unit potency to about 0.6 unit potency. In one aspect, each dose is in a volume of approximately 5 μL to approximately 500 μL, for example, approximately 5 μL to 450 μL, approximately 5 μL to 400 μL, approximately 5 μL to 350 μL, approximately 5 μL to 300 μL, approximately 5 μL to 250 μL, approximately 5 μL to 200 μL, approximately 5 μL to 150 μL, approximately 5 μL to 100 μL, approximately 5 μL to 50 μL, approximately 5 μL to 40 μL, approximately 5 μL to 30 μL, approximately 5 μL to 20 μL, and approximately 5 μL to 10 μL. The product is provided in volumes of approximately 50 μL to 500 μL, approximately 50 μL to 450 μL, approximately 50 μL to 400 μL, approximately 50 μL to 350 μL, approximately 50 μL to 300 μL, approximately 50 μL to 250 μL, approximately 50 μL to 200 μL, approximately 50 μL to 150 μL, approximately 50 μL to 100 μL, approximately 100 μL to 500 μL, approximately 150 μL to 450 μL, approximately 200 μL to 400 μL, or approximately 250 μL to 350 μL. In one embodiment, a pair of doses are provided to the subject requiring it at intervals of approximately two weeks, for example, 10, 11, 12, 13, 14, 15, 16, 17, or 18 days apart. In one embodiment, a pair of doses are provided to the subject requiring them at intervals of approximately three weeks, for example, 17, 18, 19, 20, 21, 22, 23, 24, or 25 days apart.In one embodiment, the dose administered by this method is provided to the subject in need over a period of approximately 2 weeks to approximately 27 weeks, for example, approximately 2 weeks to approximately 26 weeks, for example, approximately 2 weeks to approximately 25 weeks, for example, approximately 2 weeks to approximately 24 weeks, for example, approximately 2 weeks to approximately 23 weeks, for example, approximately 2 weeks to approximately 22 weeks, for example, approximately 2 weeks to approximately 21 weeks, for example, approximately 2 weeks to approximately 20 weeks, for example, approximately 2 weeks to approximately 19 weeks, for example, approximately 2 weeks to approximately 18 weeks, for example, approximately 2 weeks to approximately 17 weeks, for example It will be provided over a period of approximately 2 to 16 weeks, for example, approximately 2 to 15 weeks, for example, approximately 2 to 14 weeks, for example, approximately 2 to 13 weeks, for example, approximately 2 to 12 weeks, for example, approximately 2 to 11 weeks, for example, approximately 2 to 10 weeks, for example, approximately 2 to 9 weeks, for example, approximately 2 to 8 weeks, for example, approximately 2 to 7 weeks, for example, approximately 2 to 6 weeks, for example, approximately 2 to 5 weeks, for example, approximately 2 to 4 weeks, or for example, approximately 2 to 3 weeks. In one embodiment, the dose administered by this method is provided to subjects in need over a period of approximately 3 to 27 weeks, for example, approximately 4 to 27 weeks, approximately 5 to 27 weeks, approximately 6 to 27 weeks, approximately 7 to 27 weeks, approximately 8 to 27 weeks, approximately 9 to 27 weeks, approximately 10 to 27 weeks, approximately 11 to 27 weeks, approximately 12 to 27 weeks, and approximately 13 to 27 weeks. It is offered over a period of approximately 14 to 27 weeks, 15 to 27 weeks, 16 to 27 weeks, 17 to 27 weeks, 18 to 27 weeks, 19 to 27 weeks, 20 to 27 weeks, 21 to 27 weeks, 22 to 27 weeks, 23 to 27 weeks, 24 to 27 weeks, 25 to 27 weeks, or 26 to 27 weeks. In one embodiment, the dose administered by this method is provided to subjects in need over a period of approximately 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 17 weeks, 18 weeks, 19 weeks, 20 weeks, 21 weeks, 22 weeks, 23 weeks, 24 weeks, 25 weeks, 26 weeks, or 27 weeks.

[0149] In one embodiment, the intrafocal injection is provided to a subject requiring it. In one embodiment, the intrafocal injection is provided to the periphery of the verruca vulgaris to be treated. In one embodiment, the intrafocal injection is provided near the periphery of the verruca vulgaris to be treated. In one embodiment, the intrafocal injection is provided at a location within approximately 5 mm from the periphery of the verruca vulgaris to be treated, for example, within approximately 4 mm, 3 mm, 2 mm, or 1 mm from the periphery of the verruca vulgaris. In one embodiment, the periphery is defined by the periphery of the verruca. In one embodiment, the intrafocal injection is provided to the verruca vulgaris to be treated. In one embodiment, in the presence of multiple verruca vulgaris within the same anatomical region, the intrafocal injection is provided to the largest verruca vulgaris within the anatomical region. In one embodiment, an intrafocal injection is delivered to the largest common wart within an anatomical region in the presence of multiple common and non-common warts within the same anatomical region. In one embodiment, the largest common wart is determined by selecting the common wart with the largest diameter within the anatomical region.

[0150] In one embodiment, a subject has a common wart measuring between approximately 3 mm and approximately 20 mm prior to the commencement of treatment according to the present disclosure, for example, between approximately 3 mm and approximately 19 mm, between approximately 4 mm and approximately 20 mm, between approximately 4 mm and approximately 19 mm, between approximately 5 mm and approximately 19 mm, between approximately 5 mm and approximately 18 mm, between approximately 6 mm and approximately 18 mm, between approximately 6 mm and approximately 17 mm, between approximately 7 mm and approximately 16 mm, between approximately 7 mm and approximately 15 mm, between approximately 8 mm and approximately 15 mm, between approximately 8 mm and approximately 14 mm, between approximately 9 mm and approximately 14 mm, between approximately 9 mm and approximately 13 mm, between approximately 10 mm and approximately 13 mm, between approximately 10 mm and approximately 12 mm, or between approximately 11 mm and approximately 12 mm. In one embodiment, the subject has common warts with dimensions between approximately 20 mm and approximately 1 cm, for example between approximately 20 mm and approximately 95 mm, for example between 25 mm and approximately 1 cm, for example between approximately 20 mm and approximately 90 mm, for example between approximately 25 mm and approximately 95 mm, for example between approximately 25 mm and approximately 90 mm, for example between approximately 30 mm and approximately 90 mm, for example between approximately 30 cm and approximately 85 mm, for example between approximately 35 mm and approximately 85 mm, for example between approximately 35 mm and approximately 80 mm, for example between approximately 40 mm and approximately 80 mm, for example between approximately 40 mm and approximately 75 mm, for example between approximately 45 mm and approximately 75 mm, for example between approximately 45 mm and approximately 60 mm, for example between approximately 50 mm and approximately 70 mm, for example between approximately 50 mm and approximately 65 mm, for example between approximately 55 mm and approximately 65 mm, or for example between approximately 55 mm and approximately 60 mm.In one embodiment, the subject is a common wart with dimensions between approximately 1 cm and approximately 100 cm, for example, between approximately 1 cm and approximately 95 cm, between approximately 5 cm and approximately 100 cm, between approximately 5 cm and approximately 95 cm, between approximately 10 cm and approximately 95 cm, between approximately 10 cm and approximately 90 cm, between approximately 15 cm and approximately 90 cm, between approximately 15 cm and approximately 85 cm, between approximately 20 cm and approximately 85 cm, between approximately 20 cm and approximately 80 cm, and approximately 25 cm. The patient has common warts measuring between m and approximately 80 cm, between approximately 25 cm and approximately 75 cm, between approximately 30 cm and approximately 75 cm, between approximately 30 cm and approximately 70 cm, between approximately 35 cm and approximately 70 cm, between approximately 35 cm and approximately 65 cm, between approximately 40 cm and approximately 65 cm, between approximately 40 cm and approximately 60 cm, between approximately 45 cm and approximately 60 cm, between approximately 45 cm and approximately 55 cm, or between approximately 50 cm and approximately 55 cm.

[0151] In one embodiment, two or more intrafocal injections are provided to a subject in need over a single time period. In one embodiment, each of the two or more intrafocal injections is provided in a dose of at least 0.5 unit potency. In one embodiment, each of the two or more intrafocal injections is administered in a dose of at least about 0.1 unit potency to about 1 unit potency, for example, about 0.1 unit potency to about 0.9 unit potency, for example, about 0.2 unit potency to about 1 unit potency, for example, about 0.2 unit potency to about 0.8 unit potency, for example, about 0.3 unit potency to about 0.7 unit potency, or for example, about 0.4 unit potency to about 0.6 unit potency. In one aspect, each of two or more intralesional injections is in a volume of approximately 5 μL to approximately 500 μL, for example, approximately 5 μL to approximately 450 μL, approximately 5 μL to approximately 400 μL, approximately 5 μL to approximately 350 μL, approximately 5 μL to approximately 300 μL, approximately 5 μL to approximately 250 μL, approximately 5 μL to approximately 200 μL, approximately 5 μL to approximately 150 μL, approximately 5 μL to approximately 100 μL, approximately 5 μL to approximately 50 μL, approximately 5 μL to approximately 40 μL, approximately 5 μL to approximately 30 μL, approximately 5 μL to approximately 20 μL, approximately 5 μL to It is supplied in volumes of approximately 10 μL, approximately 50 μL to approximately 500 μL, approximately 50 μL to approximately 450 μL, approximately 50 μL to approximately 400 μL, approximately 50 μL to approximately 350 μL, approximately 50 μL to approximately 300 μL, approximately 50 μL to approximately 250 μL, approximately 50 μL to approximately 200 μL, approximately 50 μL to approximately 150 μL, approximately 50 μL to approximately 100 μL, approximately 100 μL to approximately 500 μL, approximately 150 μL to approximately 450 μL, approximately 200 μL to approximately 400 μL, or approximately 250 μL to approximately 350 μL.

[0152] In one embodiment, one of two or more intrafocal injections is provided to a subject requiring it at intervals of approximately two weeks, for example, 10, 11, 12, 13, 14, 15, 16, 17, or 18 days apart. In one embodiment, one of two or more intrafocal injections is provided to a subject requiring it at intervals of approximately three weeks, for example, 17, 18, 19, 20, 21, 22, 23, 24, or 25 days apart.

[0153] In one embodiment, two or more intrafocal injections are provided to subjects in need over a period of approximately 2 weeks to approximately 27 weeks, for example, approximately 2 weeks to approximately 26 weeks, for example, approximately 2 weeks to approximately 25 weeks, for example, approximately 2 weeks to approximately 24 weeks, for example, approximately 2 weeks to approximately 23 weeks, for example, approximately 2 weeks to approximately 22 weeks, for example, approximately 2 weeks to approximately 21 weeks, for example, approximately 2 weeks to approximately 20 weeks, for example, approximately 2 weeks to approximately 19 weeks, for example, approximately 2 weeks to approximately 18 weeks, for example, approximately 2 weeks to approximately 17 weeks, for example, approximately It is provided over a period of 2 weeks to approximately 16 weeks, for example, approximately 2 weeks to approximately 15 weeks, for example, approximately 2 weeks to approximately 14 weeks, for example, approximately 2 weeks to approximately 13 weeks, for example, approximately 2 weeks to approximately 12 weeks, for example, approximately 2 weeks to approximately 11 weeks, for example, approximately 2 weeks to approximately 10 weeks, for example, approximately 2 weeks to approximately 9 weeks, for example, approximately 2 weeks to approximately 8 weeks, for example, approximately 2 weeks to approximately 7 weeks, for example, approximately 2 weeks to approximately 6 weeks, for example, approximately 2 weeks to approximately 5 weeks, for example, approximately 2 weeks to approximately 4 weeks, or for example, approximately 2 weeks to approximately 3 weeks. In one embodiment, two or more intra-focal injections are provided to subjects in need over a period of approximately 3 to 27 weeks, for example, approximately 4 to 27 weeks, approximately 5 to 27 weeks, approximately 6 to 27 weeks, approximately 7 to 27 weeks, approximately 8 to 27 weeks, approximately 9 to 27 weeks, approximately 10 to 27 weeks, approximately 11 to 27 weeks, approximately 12 to 27 weeks, approximately 13 to 27 weeks, It is offered over a period of approximately 14 to 27 weeks, 15 to 27 weeks, 16 to 27 weeks, 17 to 27 weeks, 18 to 27 weeks, 19 to 27 weeks, 20 to 27 weeks, 21 to 27 weeks, 22 to 27 weeks, 23 to 27 weeks, 24 to 27 weeks, 25 to 27 weeks, or 26 to 27 weeks. In one embodiment, two or more intrafocal injections are provided to subjects in need over a period of approximately 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 16 weeks, 17 weeks, 18 weeks, 19 weeks, 20 weeks, 21 weeks, 22 weeks, 23 weeks, 24 weeks, 25 weeks, 26 weeks, or 27 weeks.

[0154] In one embodiment, two or more intrafocal injections are provided to subjects in need, in two or more subgroups of intrafocal injections, over a single time period. In one embodiment, each of the two or more subgroups is provided in a dose of at least 0.5 unit potency. In one embodiment, each of the two or more subgroups is provided in a dose of at least about 0.1 unit potency to about 1 unit potency, for example, about 0.1 unit potency to about 0.9 unit potency, for example, about 0.2 unit potency to about 1 unit potency, for example, about 0.2 unit potency to about 0.8 unit potency, for example, about 0.3 unit potency to about 0.7 unit potency, or about 0.4 unit potency to about 0.6 unit potency. In one embodiment, each of two or more subgroups is supplied in volumes ranging from approximately 5 μL to approximately 500 μL, for example, approximately 5 μL to approximately 450 μL, approximately 5 μL to approximately 400 μL, approximately 5 μL to approximately 350 μL, approximately 5 μL to approximately 300 μL, approximately 5 μL to approximately 250 μL, approximately 5 μL to approximately 200 μL, approximately 5 μL to approximately 150 μL, approximately 5 μL to approximately 100 μL, approximately 5 μL to approximately 50 μL, approximately 5 μL to approximately 40 μL, approximately 5 μL to It is supplied in volumes of approximately 30 μL, approximately 5 μL to approximately 20 μL, approximately 5 μL to approximately 10 μL, approximately 50 μL to approximately 500 μL, approximately 50 μL to approximately 450 μL, approximately 50 μL to approximately 400 μL, approximately 50 μL to approximately 350 μL, approximately 50 μL to approximately 300 μL, approximately 50 μL to approximately 250 μL, approximately 50 μL to approximately 200 μL, approximately 50 μL to approximately 150 μL, approximately 50 μL to approximately 100 μL, approximately 100 μL to approximately 500 μL, approximately 150 μL to approximately 450 μL, approximately 200 μL to approximately 400 μL, or approximately 250 μL to approximately 350 μL.

[0155] In one embodiment, a pair of subgroups within two or more subgroups of intrafocal injections is provided to subjects requiring it at intervals of approximately two weeks, for example, 10, 11, 12, 13, 14, 15, 16, 17, or 18 days apart. In one embodiment, a pair of subgroups within two or more subgroups of intrafocal injections is provided to subjects requiring it at intervals of approximately three weeks, for example, 17, 18, 19, 20, 21, 22, 23, 24, or 25 days apart.

[0156] In one aspect, a subgroup of intrafocal injections includes at least two intrafocal injections, for example, two intrafocal injections, three intrafocal injections, four intrafocal injections, five intrafocal injections, six intrafocal injections, seven intrafocal injections, eight intrafocal injections, nine intrafocal injections, or ten intrafocal injections.

[0157] In one embodiment, intrafocal injections within a subgroup of intrafocal injections are administered almost simultaneously, for example, within approximately 1 minute, 2 minutes, 3 minutes, 4 minutes, or 5 minutes. In one embodiment, intrafocal injections within a subgroup of intrafocal injections are administered within 24 hours, for example, within approximately 18 hours, 12 hours, 6 hours, 5 hours, 4 hours, 3 hours, 2 hours, or 1 hour.

[0158] In one embodiment, intrafocal injections within a subgroup of intrafocal injections are provided around the verruca vulgaris being treated. In one embodiment, intrafocal injections within a subgroup of intrafocal injections are arranged at equal intervals near the periphery of the verruca vulgaris being treated. In one embodiment, each intrafocal injection within a subgroup of intrafocal injections is provided at a position of approximately 5 mm or less from the periphery of the verruca vulgaris being treated, for example, at a position of approximately 4 mm or less, approximately 3 mm or less, approximately 2 mm or less, or approximately 1 mm or less from the periphery of the verruca vulgaris. In one embodiment, intrafocal injections within a subgroup of intrafocal injections are arranged at equal intervals along the periphery of the verruca vulgaris being treated. In one embodiment, the periphery is defined by the periphery of the verruca.

[0159] In one embodiment, the pharmaceutical composition administered by the method of the present disclosure comprises a filtered extract of two strains of Candida albicans and secretory antigens, wherein a representative sample of the first strain is deposited with ATCC under ATCC accession number PTA-126019, and a representative sample of the second strain is deposited with ATCC under ATCC accession number PTA-126020. In one embodiment, a representative sample of the first strain is deposited with ATCC under ATCC accession number ATCC-10231.

[0160] In one embodiment, the subjects treated by the method of this disclosure are between 18 and 65 years of age, for example, between 20 and 60 years of age, between 18 and 30 years of age, between 25 and 50 years of age, between 30 and 40 years of age, between 40 and 50 years of age, or between 50 and 65 years of age. In one embodiment, the subjects treated by the method of this disclosure are pediatric patients. In one embodiment, the pediatric patient is an early neonatal. In one embodiment, the pediatric patient is in the neonatal period. In one embodiment, the pediatric patient is a neonatal. In one embodiment, the pediatric patient is an infant. In one embodiment, the pediatric patient is a toddler. In one embodiment, the pediatric patient is a young child. In one embodiment, the pediatric patient is a child. In one embodiment, the pediatric patient is an adolescent. In one embodiment, the pediatric patient is a child under approximately 18, 15, 12, 10, 8, 6, 4, 3, 2, or 1 year of age. In one embodiment, the subject treated by the method of the present disclosure has been diagnosed with a first common wart at least 12 weeks prior to receiving one or more intrafocal injections, for example, between 12 and 100 weeks, between 15 and 90 weeks, between 20 and 80 weeks, between 25 and 75 weeks, between 30 and 70 weeks, between 35 and 65 weeks, between 40 and 60 weeks, between 45 and 55 weeks, or between 50 and 55 weeks. In one embodiment, the subjects treated by the method of this disclosure were not diagnosed with refractory warts. In one embodiment, refractory warts are warts that have not been successfully treated by prior treatments other than over-the-counter (OTC) drugs. In one embodiment, refractory warts are warts that have not been successfully treated by one or more types of prior treatments, e.g., two or more, three or more, four or more, five or more, six or more, seven or more, eight or more, nine or more, or ten or more types of prior treatments. In one embodiment, OTC drugs are medicines that are sold directly to consumers without a prescription from a healthcare professional.

[0161] In one embodiment, subjects treated by the method of this disclosure have a baseline result between 5 mm and 25 mm for a delayed-type hypersensitivity (DTH) test. In one embodiment, the DTH test is performed by administering a single intradermal injection of CANDIN® (0.1 mL; Allermed / Nielsen Biosciences) at a location at least 2 cm away from any primary injectable wart on the palmar surface of the forearm or the lateral surface of the upper arm. The skin is wiped with 70% alcohol before applying the skin test. The intradermal injection is performed as superficially as possible, thereby resulting in a clear and well-defined bleb. The test is read by visually inspecting the test site and palpating the indurated area 48 ± 4 hours after the DTH exposure injection. Measurements are taken in two diameters. The mean of the longest and midpoint orthogonal diameters of the indurated area is reported as the DTH response.

[0162] In one embodiment, subjects treated by the method of this disclosure have not been diagnosed with a systemic disease that impairs immune function. In one embodiment, subjects treated by the method of this disclosure have not been diagnosed with a focal disease that impairs immune function. In one embodiment, subjects treated by the method of this disclosure have not been diagnosed with a systemic condition that impairs immune function. In one embodiment, subjects treated by the method of this disclosure have not been diagnosed with a focal condition that impairs immune function. In one embodiment, subjects treated by the method of this disclosure have not been diagnosed with psoriasis. In one embodiment, subjects treated by the method of this disclosure have not received treatment that would result in an immunocompromised state.

[0163] In one embodiment, the subjects treated by the method of this disclosure have not been diagnosed with diabetes. In one embodiment, the subject treated by the method of this disclosure has no history of keloid formation. In one embodiment, the subject treated by the method of this disclosure has no pre-existing dermatological conditions in the same anatomical region as the wart being treated. In one embodiment, the subject treated by the method of this disclosure has no underlying inflammatory condition. In one embodiment, the underlying inflammatory condition is arthritis of the joint.

[0164] In one embodiment, subjects treated by the method of the disclosure have not received one or more treatments selected from the group consisting of liquid nitrogen, carbon dioxide, electrolysis, laser, surgery, simple occlusion (e.g., duct tape), salicylic acid or related acids (including trichloroacetic acid and bichloroacetic acid), OTC drugs, and cantharidin within four weeks prior to the administration step. In one embodiment, subjects treated by the method of the disclosure have not received one or more immunotherapies selected from the group consisting of diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), imiquimod, 5-fluorouracil, bleomycin, and podophyllin within twelve weeks prior to the administration step. In one embodiment, subjects treated by the method of this disclosure have not received one or more systematic treatments selected from the group consisting of cimetidine, zinc supplements at doses higher than 20 mg of elemental zinc per day, azathioprine, 6-, mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, and steroids within 12 weeks prior to the administration step. In one embodiment, subjects treated by the method of this disclosure have not received any investigational drug within 30 days prior to the administration step. In one embodiment, subjects treated by the method of this disclosure have not received any of the above investigational drugs with a half-life of 5 or less prior to the administration step. [Examples]

[0165] Example 1: Preparation of a composition containing a sterile filtrate of Candida albicans and secreted antigens. First, preliminary cultures are prepared by aseptically removing one loopful of stock culture each of two strains of Candida albicans (ATCC accession numbers: PTA-126019 and PTA-126020) from the oil-covered stock culture and placing them in animal component-free triptycase soy broth (ATSB; TechNova (Dartmouth, Nova Scotia)). These preliminary cultures are incubated at 20-25°C until growth pellets are observed at the bottom of the tube (usually within 7-14 days). After evidence of fungal growth (e.g., milky white yeast-like growth at the bottom of the tube) is observed, a portion of the growth is transferred to an animal component-free triptycase soy agar (ATSA; TechNova (Dartmouth, Nova Scotia)) plate and incubated at 20-25°C for 3-7 days. The growth portion from the ATSA plate is subcultured onto a fresh ATSA plate, and the plate is streaked to generate isolated colonies. Incubate the ATSA plate at 20-25°C for 3-7 days.

[0166] From the ATSA plate, several isolated colonies with characteristic morphologies (see Figures 1 and 2, which show the characteristic morphologies of isolated colonies from the first and second strains, respectively) are transferred to an Erlenmeyer flask containing Chemically Defined Candida Medium (CDCM; TechNova (Dartmouth, Nova Scotia)). The CDCM consists of 3.6 g / L KH2PO4, 1.2 g / L Na2HPO4, 8.0 g / L (NH4)2SO4, 0.2 g / L MgSO4·7H2O, 0.01 g / L ZnSO4·7H2O, 8.0 g / L sucrose, and 0.01 g / L biotin. The Erlenmeyer flask is incubated on a shaker set to approximately 60 rpm at a temperature of 20-25°C for 3-7 days. Referring to Figure 1, isolated colonies of the first strain deposited under ATCC accession number PTA-126019 appear as a smooth, creamy paste with a smooth entire margin. Referring to Figure 2, isolated colonies of the second strain deposited under ATCC accession number PTA-126020 appear as a somewhat rough, white-cream color with an irregular margin.

[0167] When the inoculum shows budding yeast pseudohyphae (see Figure 3 for a diagram of Candida albicans budding yeast cells, and Figure 4 for Candida albicans pseudohyphae), and does not contain bacteria, transfer each stock to separate production flasks containing CDCM at a dilution of approximately 1:100. For example, transfer approximately 1.0 mL of each stock to a separate production flask containing 100 mL of CDCM, or transfer approximately 10 mL of each stock to a separate production flask containing 1000 mL of CDCM. Incubate the production flasks on a shaker at 20-25°C for 7 days, set to 60 rotations or vibrations per minute.

[0168] Once incubation is complete, add 1.0 mL of 1% phenol to each product flask. Store the flasks at 20-25°C for 7 days to kill the fungi. Then, pool the contents of all product flasks, which contain acceptable growth portions and are free of impurities, into sterile glass bottles. Cultivate the pooled material by adding 1.0 mL of Triptycase Soy Broth (TSB; TechNova (Dartmouth, Nova Scotia)) to each of three 40 mL tubes. Dilute each TSB culture 10-fold with TSB and incubate at 20-25°C for 7 days to ensure that no organisms survive. During the culturing period, store the pooled product material in storage bottles at 20-25°C for 7 days.

[0169] The pooled cultures are dialyzed in USP-grade Water for Injection (WFI; TechNova (Dartmouth, Nova Scotia)) at 1-8°C using Spectrapor 6,000-8,000 MWCO dialysis tubing (size 40 mm). Dialysis is performed with 20 times the volume of WFI, and the procedure is repeated twice at 24-hour intervals. The dialyzed material is then uniformly heated in a water bath at 90-95°C for 60 minutes.

[0170] 200 mL of heat-treated dialysis material is added to a 600 mL freeze-drying flask and freeze-dried in a Labconco freeze-dryer. This procedure is repeated until the entire lot is freeze-dried. The freeze-dried material is then covered with petroleum ether at 20–25°C for 6–8 hours, and the supernatant is discarded by filtration. The resulting material is air-dried in a ventilated hood. This is the dried powder shown as a source material for further processing.

[0171] The source material is diluted with a Coca glycerol solution (0.25% NaCl, 0.125% NaHCO3, 53% glycerin; 47% WFI) having a pH in the range of 6–8.5 at the desired wt / volume extraction ratio. In one embodiment, the volume extraction ratio is 1:20 w / v, and 20 mL of Coca glycerol solution is added per gram of source material. This extract is mixed intermittently on a magnetic stirrer at 1–8°C for approximately 71 hours until the source material appears homogeneous throughout the mixture.

[0172] Next, the extract is centrifuged at approximately 4000 RPM for 20 minutes. The extract is then filtered by vacuum filtration using a Buchner funnel and Whatman No. 3 filter paper. The filtered extract is adjusted to have a final concentration of 0.4% phenol, and then allowed to return to 1-8°C. The product is filtered using sterile Sartorius 0.2 μm filter capsules (#5231307H) and under a Class 100 laminar flow hood in a Class 100,000 chamber.

[0173] In a sterile filtration room, sterile Sartorius "Sartobran" 0.45 / 0.2 μm [5235307H7OOA(0.05 m 2 ) or 5231307H5OOB (0.03m 2 Sterilize the product using (). Collect the filtrate in an appropriately sized sterile depyrogenated container and store the filtrate at 1-8°C. Finally, dilute 1.7 mL of this master lot filtrate with 998.3 mL of a diluent consisting of 5.0 g / L NaCl, 2.5 g / L NaHCO3, 4.5 mL / L phenol, 1.2 mL / L 20% human serum albumin solution, and 0.8 mL / L polysorbate 80.

[0174] Example 2: Intra-focal injection for verrucae Intra-focal injection of the pharmaceutical composition of this disclosure into a wart is provided in the interdigitated base region of the wart, at the base of the wart. Figure 6 shows a preferred location for intra-focal injection. Preferably, whitening of the treated wart is observed at the time of injection. The injection should be performed slowly, but not limited to theory, to allow the pharmaceutical composition to be injected to spread along the epidermal junction. Most injections are performed with the bevel facing downward. However, for particularly thick warts, the injection may be performed with the bevel of the needle facing upward. For particularly thin warts, the injection may be performed with the bevel of the needle facing sideways. After injection, moderate pressure is applied to the injected wart.

[0175] In some cases, the dosage of the pharmaceutical composition may be injected into the alternating interlocking bases of the warts via multiple injections.

[0176] Example 3: Injection treatment for a single wart To treat patients diagnosed with verruca vulgaris, a dose of 0.5 unit potency of the pharmaceutical composition of this disclosure is provided in intrafocal injections once every two weeks (14 ± 2 days) for a maximum of 10 injections to the largest verruca vulgaris. If the primary verruca vulgaris achieves complete response, the same dose of 0.5 unit potency of the same pharmaceutical composition is injected into the second largest injectable verruca vulgaris in all anatomical regions. If the injected verruca recurs after achieving complete response, it is reinjected in place of the non-primary verruca injected at the previous visit. This injection strategy is repeated for a maximum of 10 injections, or until all injectable verruca vulgaris achieve complete response before all 10 injections are used.

[0177] The above treatment is effective in completely eliminating 85% of all primary injected warts in any number of injections, compared to 52% when a placebo is administered. Furthermore, in subjects injected with the pharmaceutical composition of this disclosure, 75% of all warts mapped at baseline completely disappeared, compared to 34% in subjects injected with placebo. The median number of injections required for complete disappearance of the first-injected warts was 5, compared to 10 injections with placebo. Furthermore, 4 months after the last injection, 50% of the first-injected warts remained completely cleared, compared to 31% with placebo.

[0178] Furthermore, the above treatment was effective in eliminating all common warts in 53% of the 52 treated subjects, compared to 21% in the placebo group. Among patients diagnosed with non-common warts, 75% showed elimination of non-common warts, compared to 57% in the placebo group.

[0179] Furthermore, the above treatment can eliminate 47% of primary injected warts previously treated with cryotherapy, compared to 21% with placebo.

[0180] Ten percent of the subjects who received the treatment showed scarring at the site of the disappeared warts, compared to 6% of the subjects who received placebo. Three percent of the subjects who received the treatment showed depigmentation at the site of the disappeared warts, compared to 0% of the subjects who received placebo.

[0181] Example 4: Injection treatment of multiple warts To treat patients diagnosed with common warts in at least two different anatomical regions, the pharmaceutical composition of this disclosure is administered to the largest common wart (primary) in each anatomical region by injection at a minimum of two and a maximum of four times per visit every two weeks (14 ± 2 days), for a maximum of 10 injection visits. No more than two warts per anatomical region are injected at any given visit. If any primary injected wart shows complete response, the same dose of the same pharmaceutical composition at a 0.3 unit potency is injected into the next largest injectable common wart (up to four times per visit), provided that the new injectable wart is not in the same anatomical region as any other wart currently being injected. If a wart recurs after showing complete response, it is reinjected in place of the non-primary wart that was injected at the previous visit. This injection strategy involves repeating injection visits a total of up to 10 times per subject, or until all injectable verruca vulgaris achieve complete remission before the completion of 10 injection visits.

[0182] The above treatment was effective in completely eliminating 82% of the largest primary injected warts in any given number of injections, compared to 52% with placebo. The median number of injections required for complete elimination of the largest primary injected wart was 4, compared to 10 with placebo. Furthermore, 4 months after the last injection, 43% of the largest primary injected warts remained completely eliminated, compared to 31% with placebo.

[0183] Seven percent of the subjects who received treatment showed scarring at the site of the disappeared warts, compared to 6% of the subjects who received placebo. Three percent of the subjects who received treatment showed depigmentation at the site of the disappeared warts, compared to 0% of the subjects who received placebo.

[0184] Example 5: Changes in cytokine biomarkers in patients with verrucae To evaluate changes in biomarkers in patients with warts, intra-lesional injections are provided to a total of 58 subjects. The pharmaceutical composition of this disclosure is provided to each of the 43 subjects in up to 10 injections every two weeks at a dose of 0.3 potency each, into the largest wart (primary) lesion. Meanwhile, placebo is provided to each of the 15 subjects in up to 10 injections every two weeks, into the primary wart lesion.

[0185] If the primary wart shows complete remission, the next largest wart should be treated with the same dose. This strategy is repeated until all warts disappear or until one of the following 10 injections is reached first. If a wart recurs after showing complete remission, that wart is retreated instead of the one injected at the previous visit.

[0186] Blood samples are collected at the time of screening before the start of treatment (V1), after the therapeutic injection and immediately before the third injection (V5), and at the completion of the study, i.e., when all verrucae have disappeared or after 10 injections (V13). Plasma separated from the blood is stored at -80°C until assayed for multiple protein biomarkers (45plex cytokine / chemokine / growth factor panel) from BioAgilytix (Durham, NC).

[0187] Check the results of individual samples to ensure they fall within the valid standard range. Exclude results that fall outside the valid range.

[0188] Table 1 shows summary statistics for the treatment and placebo groups at study monitoring levels for IL-23, IL-7, and IP-10. Only p-values ​​less than 0.05 are included in the table. [Table 1]

[0189] In this study, when comparing the treatment group and the placebo group, biomarker concentrations tended to be higher in the placebo group than in the treatment group at all visits, including visit 1, where a blood sample was taken before any injection. The p-value for comparing mean concentrations at each visit is reported if the difference is considered statistically significant (p<0.05). In each case, the mean concentration in the placebo group was higher than in the treatment group.

[0190] Furthermore, this study compared changes in biomarker levels relative to baseline (V13-V1) between treatment groups. Generally, a relative decrease in biomarker levels was observed in the active treatment group compared to the placebo group. Three biomarkers (IL-7, IP-10, and IL-23) showed a statistically significant decrease after treatment compared to the placebo group. Figures 7A, 7B, and 7C show the comparison of changes in biomarker levels for IL-7, IP-10, and IL-23, respectively, using one-way ANOVA analysis. A represents the treatment group, P represents the placebo group, and changes in biomarker levels are reported in pg / mL.

[0191] The active treatment group was subdivided into those who showed complete clearance of all treated verrucae and those who showed complete clearance of less than 50%. Comparing the mean post-treatment changes between these two subgroups revealed a significant difference in the cytokine IL-23. The change observed in the high-responder subgroup corresponded to a 35% decrease from baseline, while the low-responder subgroup showed a 5% decrease. In contrast, the placebo group showed an average increase of 35% in IL-23 concentration. Example 6: Injection treatment of a single wart

[0192] To treat patients aged 12–65 years with between 3 and 20 common warts, a dose of 0.3 unit potency of the pharmaceutical composition of this disclosure is provided to the largest common wart once every two weeks (14 ± 2 days) for a maximum of six intralesional injections. If the primary common warts achieve complete remission, the same dose of 0.3 unit potency of the same pharmaceutical composition is injected into the second largest injectable common wart in all anatomical regions. If the injected warts recur after achieving complete remission, the warts are reinjected instead of the non-primary warts injected at the previous visit. This injection strategy is repeated for a maximum of six injections, or until all injectable common warts achieve complete remission before all six injections are used. Complete clearance of the primary warts is determined one month after the last injection.

[0193] The above treatment is effective in completely eliminating 66% of all primary injected warts in any number of injections, compared to 37% when a placebo is administered. The median number of injections required for complete disappearance of the first-injected warts was 5, compared to 10 injections with placebo. Furthermore, 4 months after the last injection, 46% of the first-injected warts remained completely cleared, compared to 37% with placebo.

[0194] Furthermore, the above treatment was effective in eliminating all common warts in 32% of the 61 patients treated, compared to 21% in the placebo group.

[0195] From the above, it will be understood that the present invention can be realized in various ways. Such methods include, but are not limited to, the following:

[0196] Embodiment 1. A method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency in an amount effective for the complete disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0197] Embodiment 2. The method according to Embodiment 1, wherein the pharmaceutical composition is further effective in reducing the diameter of the common wart by at least 50% with a cumulative dose of one unit potency.

[0198] Embodiment 3. A method for treating common warts in a subject requiring treatment for said common warts, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 units potency, in an amount sufficient to cause complete disappearance of the common warts, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0199] Embodiment 4. The method according to Embodiment 3, wherein the pharmaceutical composition is further capable of reducing the diameter of the common wart by at least 50% with a cumulative dose of one unit potency.

[0200] Embodiment 5. The method according to Embodiment 1 or 3, wherein complete disappearance is identified by observing that the common wart does not recur at the same site at least 20 weeks after administration of the first intralesional injection.

[0201] Embodiment 6. The method according to Embodiment 1 or 3, wherein the complete disappearance is accompanied by the absence of scarring at the location of the common wart.

[0202] Embodiment 7. The method according to Embodiment 1 or 3, wherein the complete disappearance is accompanied by a low level of depigmentation at the site of the common wart.

[0203] Embodiment 8. The method according to any one of Embodiments 1 to 4, wherein, prior to the administration, the common wart is between approximately 3 mm and approximately 20 mm in size.

[0204] Embodiment 9. The method according to any one of Embodiments 1 to 4, wherein the administration is to provide an intra-lesional injection to the subject.

[0205] Embodiment 10. The method according to Embodiment 9, wherein the administration is an intra-lesional injection near the edge of the common wart.

[0206] Embodiment 11. The method according to Embodiment 9, wherein the administration is to provide an intralesional injection to the periphery of the common wart.

[0207] Embodiment 12. The method according to Embodiment 9, wherein the administration provides intra-focal injection within the common wart.

[0208] Embodiment 13. The method according to any one of Embodiments 1 to 4, wherein the administration provides two or more intralesional injections to the subject.

[0209] Embodiment 14. The method according to Embodiment 13, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0210] Embodiment 15. The method according to any one of Embodiments 1 to 4, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0211] Embodiment 16. The method according to Embodiment 15, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0212] Embodiment 17. The method according to Embodiment 15, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0213] Embodiment 18. The method according to Embodiment 15, wherein the two or more intra-lesional injections are provided to the subject for at least about eight weeks.

[0214] Embodiment 19. The method according to Embodiment 13, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0215] Embodiment 20. The method according to Embodiment 19, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

[0216] Embodiment 21. The method according to Embodiment 19 or 20, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0217] Embodiment 22. The method according to Embodiment 19 or 20, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0218] Embodiment 23. The method according to Embodiment 19 or 20, wherein two or more subgroups of intra-lesional injections are provided to the subject for at least about eight weeks.

[0219] Embodiment 24. The method according to Embodiment 19 or 20, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the common wart.

[0220] Embodiment 25. The method according to Embodiment 19 or 20, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the common wart.

[0221] Embodiment 26. The method according to Embodiment 19 or 20, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the common wart.

[0222] Embodiment 27. The method according to Embodiment 19 or 20, wherein one subgroup within the two or more subgroups comprises five injections around the common wart.

[0223] Embodiment 28. The method according to Embodiment 19 or 20, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the common wart.

[0224] Embodiment 29. The method according to any one of Embodiments 24 to 28, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the common wart.

[0225] Embodiment 30. The method according to any one of Embodiments 24 to 28, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals along the periphery of the common wart.

[0226] Embodiment 31. The method according to any one of Embodiments 24 to 28, wherein the intra-lesion injections within the subgroup are administered almost simultaneously.

[0227] Embodiment 32. A method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0228] Embodiment 33. The method according to Embodiment 32, wherein the pharmaceutical composition is further effective in reducing the diameter of the common wart by at least 50% with a cumulative dose of one unit potency.

[0229] Embodiment 34. A method for treating verruca vulgaris in a subject requiring treatment for said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of partial disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0230] Embodiment 35. The method according to Embodiment 34, wherein the pharmaceutical composition is further capable of reducing the diameter of the common wart by at least 50% with a cumulative dose of one unit potency.

[0231] Embodiment 36. The method according to Embodiment 32 or 34, wherein the partial disappearance is identified by a reduction in the diameter of the wart.

[0232] Embodiment 37. The method according to any one of Embodiments 32 to 35, wherein, prior to the administration, the common wart is between approximately 3 mm and approximately 20 mm in size.

[0233] Embodiment 38. The method according to any one of Embodiments 32 to 35, wherein the administration is to provide an intra-lesional injection to the subject.

[0234] Embodiment 39. The method according to Embodiment 38, wherein the administration is an intra-lesional injection near the edge of the common wart.

[0235] Embodiment 40. The method according to Embodiment 38, wherein the administration is to provide an intralesional injection to the periphery of the common wart.

[0236] Embodiment 41. The method according to Embodiment 38, wherein the administration provides intra-focal injection within the common wart.

[0237] Embodiment 42. The method according to any one of Embodiments 32 to 35, wherein the administration provides two or more intra-lesional injections to the subject.

[0238] Embodiment 43. The method according to Embodiment 42, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0239] Embodiment 44. The method according to any one of Embodiments 32 to 35, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0240] Embodiment 45. The method according to Embodiment 44, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0241] Embodiment 46. The method according to Embodiment 44, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0242] Embodiment 47. The method according to Embodiment 44, wherein the two or more intralesional injections are provided to the subject for at least about 18 weeks.

[0243] Embodiment 48. The method of Embodiment 42, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0244] Embodiment 49. The method according to Embodiment 48, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

[0245] Embodiment 50. The method according to Embodiment 48 or 49, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0246] Embodiment 51. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

[0247] Embodiment 52. The method according to Embodiment 48 or 49, wherein two or more subgroups of intralesional injections are provided to the subject for at least about 18 weeks.

[0248] Embodiment 53. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the common wart.

[0249] Embodiment 54. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the common wart.

[0250] Embodiment 55. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the common wart.

[0251] Embodiment 56. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups comprises five injections around the common wart.

[0252] Embodiment 57. The method according to Embodiment 48 or 49, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the common wart.

[0253] Embodiment 58. The method according to any one of Embodiments 52 to 57, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the common wart.

[0254] Embodiment 59. The method according to any one of Embodiments 52 to 57, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals along the periphery of the common wart.

[0255] Embodiment 60. The method according to any one of Embodiments 52 to 57, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

[0256] Embodiment 61. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial disappearance of said multiple verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0257] Embodiment 62. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of partial disappearance of said multiple verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0258] Embodiment 63. The method according to Embodiment 61 or 62, wherein the partial disappearance is identified by a reduction in the diameter of the wart.

[0259] Embodiment 64. The method according to Embodiment 61 or 62, wherein the plurality of common warts comprises 3 to 20 common warts.

[0260] Embodiment 65. The method according to Embodiment 61 or 62, wherein the multiple verruca vulgaris are located in the same anatomical position on the subject.

[0261] Embodiment 66. The method according to Embodiment 61 or 62, wherein the administration is to provide an intra-lesional injection to the subject.

[0262] Embodiment 67. The method according to Embodiment 61 or 62, wherein the administration provides two or more intralesional injections to the subject.

[0263] Embodiment 68. The method of Embodiment 67, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0264] Embodiment 69. The method according to Embodiment 68, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0265] Embodiment 70. The method according to Embodiment 68, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0266] Embodiment 71. The method according to Embodiment 68, wherein the two or more intralesional injections are provided to the subject for at least about 18 weeks.

[0267] Embodiment 72. The method according to Embodiment 67, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0268] Embodiment 73. The method according to Embodiment 61 or 62, further comprising identifying the largest common wart among the plurality of common warts.

[0269] Embodiment 74. The method according to Embodiment 73, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

[0270] Embodiment 75. The method according to Embodiment 73, wherein the administration is to provide an intrafocal injection to the periphery of the largest common wart.

[0271] Embodiment 76. The method according to Embodiment 73, wherein the administration is to provide an intra-lesional injection near the edge of the largest common wart.

[0272] Embodiment 77. The method according to Embodiment 73, wherein the administration provides an intrafocal injection within the largest common wart.

[0273] Embodiment 78. The method according to Embodiment 73, wherein the administration provides two or more intralesional injections to the largest common wart.

[0274] Embodiment 79. The method according to Embodiment 78, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0275] Embodiment 80. The method according to Embodiment 78 or 79, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0276] Embodiment 81. The method according to embodiment 80, wherein a pair of intralesional injections among the two or more intralesional injections are provided to the subject at an interval of about two weeks.

[0277] Embodiment 82. The method according to embodiment 80, wherein a pair of intralesional injections among the two or more intralesional injections are provided to the subject at an interval of about three weeks.

[0278] Embodiment 83. The method according to embodiment 80, wherein the two or more intralesional injections are provided to the subject over at least about 18 weeks.

[0279] Embodiment 84. The method according to embodiment 78, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over one time period.

[0280] Embodiment 85. The method according to embodiment 84, wherein one subgroup within the subgroup of the two or more intralesional injections provides a total dose of at least 0.5 unit titer.

[0281] Embodiment 86. The method according to embodiment 84 or 85, wherein a pair of subgroups within the subgroup of the two or more intralesional injections are provided to the subject at an interval of about two weeks.

[0282] Embodiment 87. The method according to embodiment 84 or 85, wherein a pair of subgroups within the subgroup of the two or more intralesional injections are provided to the subject at an interval of about three weeks.

[0283] Embodiment 88. The method according to embodiment 84 or 85, wherein the subgroup of the two or more intralesional injections are provided to the subject over at least about 18 weeks.

[0284] Embodiment 89. The method according to embodiment 84 or 85, wherein one subgroup within the two or more subgroups includes two intralesional injections around the largest common wart.

[0285] Embodiment 90. The method according to Embodiment 84 or 85, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the largest common wart.

[0286] Embodiment 91. The method according to Embodiment 84 or 85, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the largest common wart.

[0287] Embodiment 92. The method according to Embodiment 84 or 85, wherein one subgroup within the two or more subgroups comprises five injections around the largest common wart.

[0288] Embodiment 93. The method according to Embodiment 84 or 85, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the largest common wart.

[0289] Embodiment 94. The method according to any one of Embodiments 89 to 93, wherein the intra-lesion injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

[0290] Embodiment 95. The method according to any one of Embodiments 89 to 93, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

[0291] Embodiment 96. The method according to any one of Embodiments 89 to 93, wherein the intra-lesion injections within the subgroup are administered almost simultaneously.

[0292] Embodiment 97. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 1 unit potency that is effective in reducing the diameter of each of the multiple verruca vulgaris by at least 50%, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0293] Embodiment 98. A method for treating a plurality of common warts in a subject requiring treatment of the plurality of common warts, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 1 unit titer in an amount capable of reducing the diameter of each of the plurality of common warts by at least 50%, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secreted antigen.

[0294] Embodiment 99. The method according to Embodiment 97 or 98, wherein the plurality of common warts comprises 3 to 20 common warts.

[0295] Embodiment 100. The method according to Embodiment 97 or 98, wherein the plurality of common warts is within the same anatomical location of the subject.

[0296] Embodiment 101. The method according to Embodiment 97 or 98, wherein the administration is by providing intralesional injection to the subject.

[0297] Embodiment 102. The method according to Embodiment 97 or 98, wherein the administration is by providing two or more intralesional injections to the subject.

[0298] Embodiment 103. The method according to Embodiment 102, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0299] Embodiment 104. The method according to Embodiment 103, wherein a pair of the two or more intralesional injections are provided to the subject at approximately two-week intervals.

[0300] Embodiment 105. The method according to Embodiment 103, wherein a pair of the two or more intralesional injections are provided to the subject at approximately three-week intervals.

[0301] Embodiment 106. The method according to Embodiment 102, wherein each of the two or more intralesional injections is provided at a dose of at least 0.5 unit titer.

[0302] Embodiment 107. The method according to Embodiment 97 or 98, further comprising identifying the largest common wart among the plurality of common warts.

[0303] Embodiment 108. The method according to Embodiment 107, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

[0304] Embodiment 109. The method according to Embodiment 107, wherein the administration is to provide an intrafocal injection to the periphery of the largest common wart.

[0305] Embodiment 110. The method according to Embodiment 107, wherein the administration is an intrafocal injection near the edge of the largest common wart.

[0306] Embodiment 111. The method according to Embodiment 107, wherein the administration provides an intrafocal injection within the largest common wart.

[0307] Embodiment 112. The method according to Embodiment 107, wherein the administration provides two or more intralesional injections to the largest common wart.

[0308] Embodiment 113. The method according to Embodiment 112, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0309] Embodiment 114. The method according to Embodiment 112 or 113, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0310] Embodiment 115. The method according to Embodiment 114, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0311] Embodiment 116. The method according to Embodiment 114, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0312] Embodiment 117. The method according to Embodiment 112, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0313] Embodiment 118. The method according to Embodiment 117, wherein each of the two or more subgroups of intralesional injections is provided in a total dose of at least 0.5 unit potency.

[0314] Embodiment 119. The method according to Embodiment 117 or 118, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0315] Embodiment 120. The method according to Embodiment 117 or 118, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0316] Embodiment 121. The method according to Embodiment 117 or 118, wherein two or more subgroups of intra-lesional injections are provided to the subject over a period of at least about two weeks.

[0317] Embodiment 122. The method according to Embodiment 117 or 118, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the largest common wart.

[0318] Embodiment 123. The method according to Embodiment 117 or 118, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the largest common wart.

[0319] Embodiment 124. The method according to Embodiment 117 or 118, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the largest common wart.

[0320] Embodiment 125. The method according to Embodiment 117 or 118, wherein one subgroup within the two or more subgroups comprises five injections around the largest common wart.

[0321] Embodiment 126. The method according to Embodiment 117 or 118, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the largest common wart.

[0322] Embodiment 127. The method according to any one of Embodiments 122 to 126, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

[0323] Embodiment 128. The method according to any one of Embodiments 122 to 126, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

[0324] Embodiment 129. The method according to any one of Embodiments 122 to 126, wherein the intra-focal injections within the subgroup are administered almost simultaneously.

[0325] Embodiment 130. A method for treating non-verrucae in a subject requiring treatment for non-verrucae, the subject having one or more verrucae, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount effective for the complete disappearance of the non-verrucae, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0326] Embodiment 131. A method for treating non-verrucae in a subject requiring treatment for non-verrucae, the subject having one or more verrucae, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount sufficient to cause complete disappearance of the non-verrucae, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0327] Embodiment 132. The method according to Embodiment 130 or 131, wherein the non-common wart is a plantar wart.

[0328] Embodiment 133. The method according to Embodiment 130 or 131, wherein the non-common wart is a genital wart.

[0329] Embodiment 134. The method according to Embodiment 130 or 131, wherein the non-common wart is a facial wart.

[0330] Embodiment 135. The method according to Embodiment 130 or 131, wherein the non-common wart is a flat wart.

[0331] Embodiment 136. The method according to Embodiment 130 or 131, wherein the non-common wart is a periungual wart.

[0332] Embodiment 137. The method according to Embodiment 130 or 131, wherein the non-common wart is located in the same anatomical region as one or more common warts.

[0333] Embodiment 138. The method according to Embodiment 130 or 131, wherein complete disappearance is identified by observing that the non-common wart does not recur at the same site at least 20 weeks after administration of the first intralesional injection.

[0334] Embodiment 139. The method according to Embodiment 130 or 131, wherein the administration is to provide an intra-focal injection to the subject.

[0335] Embodiment 140. The method according to Embodiment 130 or 131, wherein the administration provides two or more intra-lesional injections to the subject.

[0336] Embodiment 141. The method according to Embodiment 140, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0337] Embodiment 142. The method according to Embodiment 141, wherein one of the two or more intralesional injections is provided to the subject at two-week intervals.

[0338] Embodiment 143. The method according to Embodiment 141, wherein one of the two or more intralesional injections is provided to the subject at a 3-week interval.

[0339] Embodiment 144. The method according to Embodiment 141, wherein two or more intralesional injections are provided to the subject over a period of 27 weeks.

[0340] Embodiment 145. The method according to Embodiment 140, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0341] Embodiment 146. The method according to Embodiment 130 or 131, wherein the one or more common warts comprise 3 to 20 common warts.

[0342] Embodiment 147. The method according to Embodiment 130 or 131, further comprising identifying the largest common wart among the one or more common warts.

[0343] Embodiment 148. The method according to Embodiment 147, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

[0344] Embodiment 149. The method according to Embodiment 147, wherein the administration is to provide an intra-lesional injection to the periphery of the largest common wart.

[0345] Embodiment 150. The method according to Embodiment 147, wherein the administration is an intrafocal injection near the edge of the largest common wart.

[0346] Embodiment 151. The method according to Embodiment 147, wherein the administration provides an intrafocal injection within the largest common wart.

[0347] Embodiment 152. The method according to Embodiment 147, wherein the administration provides two or more intralesional injections to the largest common wart.

[0348] Embodiment 153. The method according to Embodiment 152, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0349] Embodiment 154. The method according to Embodiment 152 or 153, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0350] Embodiment 155. The method according to Embodiment 154, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0351] Embodiment 156. The method according to Embodiment 154, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0352] Embodiment 157. The method according to Embodiment 154, wherein the two or more intralesional injections are provided to the subject for at least about 18 weeks.

[0353] Embodiment 158. The method according to Embodiment 152, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0354] Embodiment 159. The method according to Embodiment 158, wherein one subgroup within the two or more subgroups of intralesional injections is provided in a total dose of at least 0.5 unit potency.

[0355] Embodiment 160. The method according to Embodiment 158 ​​or 159, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0356] Embodiment 161. The method according to Embodiment 158 ​​or 159, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0357] Embodiment 162. The method according to Embodiment 158 ​​or 159, wherein two or more subgroups of intra-lesional injections are provided to the subject for at least about 18 weeks.

[0358] Embodiment 163. The method according to Embodiment 158 ​​or 159, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the largest common wart.

[0359] Embodiment 164. The method according to Embodiment 158 ​​or 159, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the largest common wart.

[0360] Embodiment 165. The method according to Embodiment 158 ​​or 159, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the largest common wart.

[0361] Embodiment 166. The method according to Embodiment 158 ​​or 159, wherein one subgroup within the two or more subgroups comprises five injections around the largest common wart.

[0362] Embodiment 167. The method according to Embodiment 158 ​​or 159, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the largest common wart.

[0363] Embodiment 168. The method according to any one of Embodiments 163 to 167, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

[0364] Embodiment 169. The method according to any one of Embodiments 163 to 167, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

[0365] Embodiment 170. The method according to any one of Embodiments 163 to 167, wherein the intra-focal injections within the subgroup are administered almost simultaneously.

[0366] Embodiment 171. A method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for the complete disappearance of said previously treated verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0367] Embodiment 172. A method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of completely clearing the previously treated verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0368] Embodiment 173. The method according to Embodiment 171 or 172, wherein the previously treated common warts are common warts that were previously treated with cryotherapy.

[0369] Embodiment 174. The method according to Embodiment 173, wherein the previously treated common warts did not respond to the cryotherapy.

[0370] Embodiment 175. The method according to Embodiment 173, wherein the cryotherapy did not completely eliminate the previously treated common warts.

[0371] Embodiment 176. The method according to Embodiment 171 or 172, wherein the previously treated verruca vulgaris is a verruca vulgaris that has been previously treated with salicylic acid or a related acid.

[0372] Embodiment 177. The method according to Embodiment 176, wherein the relevant acid is trichloroacetic acid or bichloroacetic acid.

[0373] Embodiment 178. The method according to Embodiment 176, wherein the previously treated verruca vulgaris did not respond to the salicylic acid or related acid.

[0374] Embodiment 179. The method according to Embodiment 176, wherein the salicylic acid or related acid did not completely eliminate the previously treated verruca vulgaris.

[0375] Embodiment 180. The method according to Embodiment 171 or 172, wherein the previously treated verruca vulgaris is a verruca vulgaris that has been previously treated with a treatment selected from the group consisting of liquid nitrogen, carbon dioxide, cantharidin, simple occlusion, verruca gel, apple cider vinegar, surgery, laser, tea tree oil, cryotherapy verruca spray, verruca curettage, electrocautery, lavender and oregano essential oils, and imiquimod.

[0376] Embodiment 181. The method according to Embodiment 180, wherein the previously treated common warts did not respond to the treatment.

[0377] Embodiment 182. The method according to Embodiment 180, wherein the treatment did not completely eliminate the previously treated common warts.

[0378] Embodiment 183. The method according to any one of Embodiments 171 to 182, wherein, prior to the administration, the previously treated common warts are between approximately 3 mm and approximately 20 mm in size.

[0379] Embodiment 184. The method according to any one of Embodiments 171 to 182, wherein complete disappearance is identified by observing that the previously treated verruca vulgaris does not recur at the same site at least 20 weeks after administration of the first intralesional injection.

[0380] Embodiment 185. The method according to any one of Embodiments 171 to 182, wherein the complete disappearance is accompanied by the absence of scarring at the location of the previously treated verruca vulgaris.

[0381] Embodiment 186. The method according to any one of Embodiments 171 to 182, wherein the complete disappearance is accompanied by a low level of depigmentation at the site of the previously treated verruca vulgaris.

[0382] Embodiment 187. The method according to any one of Embodiments 171 to 182, wherein the administration provides an intra-focal injection to the subject.

[0383] Embodiment 188. The method according to Embodiment 187, wherein the administration provides an intrafocal injection to the periphery of the previously treated common wart.

[0384] Embodiment 189. The method according to Embodiment 187, wherein the administration provides an intrafocal injection near the periphery of the previously treated common wart.

[0385] Embodiment 190. The method according to Embodiment 187, wherein the administration provides an intrafocal injection within the previously treated common wart.

[0386] Embodiment 191. The method according to any one of Embodiments 171 to 182, wherein the administration provides two or more intra-lesional injections to the subject.

[0387] Embodiment 192. The method according to Embodiment 191, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0388] Embodiment 193. The method according to Embodiment 191 or 192, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0389] Embodiment 194. The method according to Embodiment 193, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0390] Embodiment 195. The method according to Embodiment 193, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0391] Embodiment 196. The method according to Embodiment 193, wherein the two or more intralesional injections are provided to the subject for at least about 18 weeks.

[0392] Embodiment 197. The method according to Embodiment 191, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0393] Embodiment 198. The method according to Embodiment 197, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

[0394] Embodiment 199. The method according to Embodiment 197 or 198, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0395] Embodiment 200. The method according to Embodiment 197 or 198, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0396] Embodiment 201. The method according to Embodiment 197 or 198, wherein two or more subgroups of intralesional injections are provided to the subject for at least about 18 weeks.

[0397] Embodiment 202. The method according to Embodiment 197 or 198, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the previously treated common wart.

[0398] Embodiment 203. The method according to Embodiment 197 or 198, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the previously treated common wart.

[0399] Embodiment 204. The method according to Embodiment 197 or 198, wherein one subgroup within the two or more subgroups comprises four intrafocal injections around the previously treated common wart.

[0400] Embodiment 205. The method according to Embodiment 197 or 198, wherein one subgroup within the two or more subgroups comprises five injections around the previously treated common wart.

[0401] Embodiment 206. The method according to Embodiment 197 or 198, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the previously treated common wart.

[0402] Embodiment 207. The method according to any one of Embodiments 202 to 206, wherein the intralesional injections within the subgroup are positioned at approximately equal intervals along the periphery of the previously treated common warts.

[0403] Embodiment 208. The method according to any one of Embodiments 202 to 206, wherein the intralesional injections within the subgroup are positioned at approximately equal intervals near the edges of the previously treated common warts.

[0404] Embodiment 209. The method according to any one of Embodiments 202 to 206, wherein the intra-focal injections within the subgroup are administered almost simultaneously.

[0405] Embodiment 210. A method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount effective in delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0406] Embodiment 211. A method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount capable of delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0407] Embodiment 212. The method according to Embodiment 210 or 211, wherein the subject does not develop any new verruca vulgaris within at least 16 weeks after the last injection of the one or more intralesional injections.

[0408] Embodiment 213. The method according to Embodiment 210 or 211, wherein the subject does not develop any new verruca vulgaris within the same anatomical region as the verruca vulgaris.

[0409] Embodiment 214. The method according to Embodiment 210 or 211, wherein the subject does not develop any new verruca vulgaris in the same area as the verruca vulgaris.

[0410] Embodiment 215. The method according to Embodiment 210 or 211, wherein, prior to the administration, the common wart is between approximately 3 mm and approximately 20 mm in size.

[0411] Embodiment 216. The method according to Embodiment 210 or 211, wherein the administration is to provide an intra-lesional injection to the subject.

[0412] Embodiment 217. The method according to Embodiment 216, wherein the administration is an intra-lesional injection into the periphery of the common wart.

[0413] Embodiment 218. The method according to Embodiment 216, wherein the administration is an intra-lesional injection near the edge of the common wart.

[0414] Embodiment 219. The method according to Embodiment 216, wherein the administration provides an intrafocal injection within the common wart.

[0415] Embodiment 220. The method according to Embodiment 210 or 211, wherein the administration provides two or more intra-lesional injections to the subject.

[0416] Embodiment 221. The method according to Embodiment 220, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0417] Embodiment 222. The method according to Embodiment 220 or 221, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0418] Embodiment 223. The method according to Embodiment 222, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0419] Embodiment 224. The method according to Embodiment 222, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0420] Embodiment 225. The method according to Embodiment 222, wherein the two or more intra-lesional injections are provided to the subject for at least about eight weeks.

[0421] Embodiment 226. The method according to Embodiment 220, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0422] Embodiment 227. The method according to Embodiment 226, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

[0423] Embodiment 228. The method according to Embodiment 226 or 227, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0424] Embodiment 229. The method according to Embodiment 226 or 227, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0425] Embodiment 230. The method according to Embodiment 226 or 227, wherein two or more subgroups of intra-lesional injections are provided to the subject for at least about eight weeks.

[0426] Embodiment 231. The method according to Embodiment 226 or 227, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the common wart.

[0427] Embodiment 232. The method according to Embodiment 226 or 227, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the common wart.

[0428] Embodiment 233. The method according to Embodiment 226 or 227, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the common wart.

[0429] Embodiment 234. The method according to Embodiment 226 or 227, wherein one subgroup within the two or more subgroups comprises five injections around the common wart.

[0430] Embodiment 235. The method according to Embodiment 226 or 227, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the common wart.

[0431] Embodiment 236. The method according to any one of Embodiments 231 to 235, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals along the periphery of the common wart.

[0432] Embodiment 237. The method according to any one of Embodiments 231 to 235, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the common wart.

[0433] Embodiment 238. The method according to any one of Embodiments 231 to 235, wherein the intra-lesion injections within the subgroup are administered almost simultaneously.

[0434] Embodiment 239. The method according to any one of Embodiments 1 to 238, wherein the pharmaceutical composition contains at least 80% mannose.

[0435] Embodiment 240. The method according to any one of Embodiments 1 to 239, wherein the pharmaceutical composition contains at least 8% glucose.

[0436] Embodiment 241. The method according to any one of Embodiments 1 to 240, wherein the pharmaceutical composition comprises at least 1% galactose.

[0437] Embodiment 242. The method according to any one of Embodiments 1 to 240, wherein the antigen has a molecular weight of approximately 167 kilodaltons.

[0438] Embodiment 243. The method according to any one of Embodiments 1 to 241, wherein the subject is between 18 and 65 years of age.

[0439] Embodiment 244. The method according to any one of Embodiments 1 to 243, wherein the subject was diagnosed with a first common wart at least 12 weeks prior to receiving the one or more intra-lesional injections.

[0440] Embodiment 245. The method according to any one of Embodiments 1 to 244, wherein the subject had not been diagnosed with intractable verruca.

[0441] Embodiment 246. The method according to any one of Embodiments 1 to 245, wherein the subject has a baseline result between 5 mm and 25 mm for a delayed-type hypersensitivity test.

[0442] Embodiment 247. The method according to any one of Embodiments 1 to 246, wherein the subject has not been diagnosed with a systemic disease that impairs immune function.

[0443] Embodiment 248. The method according to any one of Embodiments 1 to 246, wherein the subject has not been diagnosed with a localized disease that impairs immune function.

[0444] Embodiment 249. The method according to any one of Embodiments 1 to 246, wherein the subject has not been diagnosed with a systemic condition that impairs immune function.

[0445] Embodiment 250. The method according to any one of Embodiments 1 to 246, wherein the subject has not been diagnosed with a localized condition that impairs immune function.

[0446] Embodiment 251. The method according to any one of Embodiments 1 to 246, wherein the subject has not been diagnosed with psoriasis.

[0447] Embodiment 252. The method according to any one of Embodiments 1 to 251, wherein the subject has not received treatment that causes an immunosuppressed state.

[0448] Embodiment 253. The method according to any one of Embodiments 1 to 252, wherein the subject has not been diagnosed with diabetes.

[0449] Embodiment 254. The method according to any one of Embodiments 1 to 253, wherein the subject does not have a history of keloid formation.

[0450] Embodiment 255. The method according to any one of Embodiments 1 to 254, wherein the subject does not have a pre-existing dermatological condition in the same anatomical region as the wart being treated.

[0451] Embodiment 256. The method according to any one of Embodiments 1 to 255, wherein the subject does not have an underlying inflammatory state.

[0452] Embodiment 257. The method according to Embodiment 256, wherein the underlying inflammatory state is an arthritis-affected joint.

[0453] Embodiment 258. The method according to any one of Embodiments 1 to 257, wherein the subject has not received one or more treatments selected from the group consisting of liquid nitrogen, carbon dioxide, electrolysis, laser, surgery, simple occlusion, salicylic acid, trichloroacetic acid, bichloroacetic acid, OTC drugs, and cantharidin within four weeks prior to the administration.

[0454] Embodiment 259. The method according to any one of Embodiments 1 to 258, wherein the subject has not received one or more immunotherapies selected from the group consisting of diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), imiquimod, 5-fluorouracil, bleomycin, and podophyllin within 12 weeks prior to the administration.

[0455] Embodiment 260. The method according to any one of Embodiments 1 to 259, wherein the subject has not received one or more systematic treatments selected from the group consisting of cimetidine, zinc supplements in doses higher than 20 mg of elemental zinc per day, azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, and steroids within 12 weeks prior to the administration.

[0456] Embodiment 261. The method according to any one of Embodiments 1 to 260, wherein the subject has not received any investigational drug within 30 days prior to the administration.

[0457] Embodiment 262. The method according to any one of Embodiments 1 to 260, wherein the subject has not received any investigational drug within five half-lives of the investigational drug prior to the administration.

[0458] Embodiment 263. A pharmaceutical product comprising a filtered extract of Candida albicans and secretory antigens, formulated to completely eliminate verruca vulgaris at a cumulative dose of 2.5 units potency.

[0459] Embodiment 264. A pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially eliminate verruca vulgaris at a cumulative dose of 5 units potency.

[0460] Embodiment 265. A pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of a common wart by at least 50% in a cumulative dose of one unit potency.

[0461] Embodiment 266. A pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to partially eliminate multiple verruca vulgaris at a cumulative dose of 5 units potency.

[0462] Embodiment 267. A pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated to reduce the diameter of multiple verruca vulgaris by at least 50% in a cumulative dose of one unit potency.

[0463] Embodiment 268. A pharmaceutical product comprising a filtered extract of Candida albicans and secretory antigens, formulated to completely eliminate non-common warts at a cumulative dose of 5 unit potency.

[0464] Embodiment 269. A pharmaceutical product comprising a filtered extract of Candida albicans and secretory antigens, formulated to completely eliminate previously treated verruca vulgaris at a cumulative dose of 5 units potency.

[0465] Embodiment 270. A pharmaceutical product comprising a filtered extract of Candida albicans and a secretory antigen, formulated in a cumulative dose of 2.5 units of potency to delay the reappearance of common warts upon their disappearance.

[0466] Embodiment 271. The pharmaceutical product according to any one of Embodiments 263 to 270, wherein the pharmaceutical product contains at least 80% mannose.

[0467] Embodiment 272. The pharmaceutical product according to any one of Embodiments 263 to 270, wherein the pharmaceutical product contains at least 8% glucose.

[0468] Embodiment 273. The pharmaceutical product according to any one of Embodiments 263 to 270, wherein the pharmaceutical product contains at least 1% galactose.

[0469] Embodiment 274. A pharmaceutical product according to any one of Embodiments 263 to 270, wherein the antigen has a molecular weight of approximately 167 kilodaltons.

[0470] Embodiment 275. The pharmaceutical product according to any one of Embodiments 263 to 274, wherein the pharmaceutical product is formulated in a vial.

[0471] Embodiment 276. The pharmaceutical product according to Embodiment 275, wherein the vial is a multi-dose storage vial.

[0472] Embodiment 277. The pharmaceutical product according to Embodiment 275, wherein the vial is a single-dose, non-storage vial.

[0473] Embodiment 278. The pharmaceutical product according to Embodiment 275, wherein the vial is a glass vial.

[0474] Embodiment 279. The pharmaceutical product according to Embodiment 278, wherein the glass vial is a 2 mL vial.

[0475] Embodiment 280. The pharmaceutical product according to any one of Embodiments 263 to 273, wherein the pharmaceutical product is formulated in a pre-filled syringe.

[0476] Embodiment 281. The pharmaceutical product according to Embodiment 280, wherein the pre-filled syringe has a volume of 0.5 mL.

[0477] Embodiment 282. A method for reducing IL-23 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of one volume of a pharmaceutical composition in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0478] Embodiment 283. The method according to Embodiment 282, wherein, upon receiving the cumulative dose, the level of IL-23 in the subject is reduced by at least about 15% compared to the level of IL-23 measured in the subject before the administration.

[0479] Embodiment 284. A method for the complete elimination of common warts in a subject requiring complete elimination of said common warts, comprising reducing the level of IL-23 in the subject requiring complete elimination of said common warts by at least about 35%.

[0480] Embodiment 285. The method according to Embodiment 284, wherein the reduction is achieved by administering to the subject one or more intrafocal injections of a single amount of a pharmaceutical composition in a cumulative dose of 3 units potency, the pharmaceutical composition comprising a filtered extract of Candida albicans and a secretory antigen.

[0481] Embodiment 286. The method according to Embodiment 284, wherein the complete disappearance is identified by observing that the common wart does not recur at the same site at least 20 weeks after the reduction.

[0482] Embodiment 287. A method for reducing IL-7 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of a single volume of a pharmaceutical composition in a cumulative dose of 0.6 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0483] Embodiment 288. The method according to Embodiment 287, wherein, upon receiving the cumulative dose, the level of IL-7 in the subject is reduced by at least about 10% compared to the level of IL-7 measured in the subject prior to the administration.

[0484] Embodiment 289. A method for reducing IL-7 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of a single volume of a pharmaceutical composition in a cumulative dose of 3 units potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0485] Embodiment 290. The method according to Embodiment 289, wherein, upon receiving the cumulative dose, the level of IL-7 in the subject is reduced by at least about 20% compared to the level of IL-7 measured in the subject prior to the administration.

[0486] Embodiment 291. A method for reducing IP-10 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a single volume of a pharmaceutical composition in a cumulative dose of 3 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

[0487] Embodiment 292. The method according to Embodiment 291, wherein, upon receiving the cumulative dose, the level of IP-10 in the subject is reduced by at least about 5% compared to the level of IP-10 measured in the subject before the administration.

[0488] Embodiment 293. The method according to any one of Embodiments 282, 283, and 285-292, wherein the administration provides an intra-focal injection to the subject.

[0489] Embodiment 294. The method according to Embodiment 293, wherein the administration is an intra-lesional injection near the edge of the common wart.

[0490] Embodiment 295. The method according to Embodiment 293, wherein the administration is an intra-lesional injection into the periphery of the common wart.

[0491] Embodiment 296. The method according to Embodiment 293, wherein the administration provides intra-focal injection within the common wart.

[0492] Embodiment 297. The method according to any one of Embodiments 282, 283, and 285-292, wherein the administration provides two or more intra-lesional injections to the subject.

[0493] Embodiment 298. The method according to Embodiment 297, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

[0494] Embodiment 299. The method according to any one of Embodiments 282, 283, and 285-292, wherein the two or more intralesional injections are provided to the subject over a single time period.

[0495] Embodiment 300. The method according to Embodiment 299, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

[0496] Embodiment 301. The method according to Embodiment 299, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

[0497] Embodiment 302. The method according to Embodiment 299, wherein the two or more intralesional injections are provided to the subject for at least about eight weeks.

[0498] Embodiment 303. The method according to Embodiment 297, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

[0499] Embodiment 304. The method according to Embodiment 303, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

[0500] Embodiment 305. The method according to Embodiment 303 or 304, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately two weeks.

[0501] Embodiment 306. The method according to Embodiment 303 or 304, wherein a pair of subgroups within the two or more subgroups of intralesional injections are provided to the subject at intervals of approximately three weeks.

[0502] Embodiment 307. The method according to Embodiment 303 or 304, wherein two or more subgroups of intralesional injections are provided to the subject for at least about eight weeks.

[0503] Embodiment 308. The method according to Embodiment 303 or 304, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the common wart.

[0504] Embodiment 309. The method according to Embodiment 303 or 304, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the common wart.

[0505] Embodiment 310. The method according to Embodiment 303 or 304, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the common wart.

[0506] Embodiment 311. The method according to Embodiment 303 or 304, wherein one subgroup within the two or more subgroups comprises five injections around the common wart.

[0507] Embodiment 312. The method according to Embodiment 303 or 304, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the common wart.

[0508] Embodiment 313. The method according to any one of Embodiments 308 to 312, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edge of the common wart.

[0509] Embodiment 314. The method according to any one of Embodiments 308 to 312, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals along the periphery of the common wart.

[0510] Embodiment 315. The method according to any one of Embodiments 308 to 312, wherein the intra-lesion injections within the subgroup are administered almost simultaneously.

[0511] Embodiment 316. The method according to any one of Embodiments 1 to 262 and 282 to 315, wherein the pharmaceutical composition comprises a filtered extract of two strains of Candida albicans and secretory antigens.

[0512] Embodiment 317. The method according to Embodiment 316, wherein a representative sample of the first strain of the two Candida albicans strains is deposited with the ATCC under ATCC accession number PTA-126019.

[0513] Embodiment 318. The method according to Embodiment 316, wherein a representative sample of the first strain of the two Candida albicans strains is deposited with the ATCC under ATCC accession number ATCC-10231.

[0514] Embodiment 319. The method according to any one of Embodiments 316 to 318, wherein a representative sample of the second strain of the two Candida albicans strains is deposited with the ATCC under ATCC accession number PTA-126020.

[0515] Embodiment 320. The pharmaceutical product according to any one of Embodiments 263 to 281, wherein the aforementioned filtered extract of Candida albicans contains two strains of Candida albicans.

[0516] Embodiment 321. The pharmaceutical product according to Embodiment 320, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number PTA-126019.

[0517] Embodiment 322. The pharmaceutical product according to Embodiment 320, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number ATCC-10231.

[0518] Embodiment 323. The pharmaceutical product according to any one of Embodiments 320 to 322, wherein a representative sample of the second strain of the two Candida albicans strains is deposited with the ATCC under ATCC accession number PTA-126020.

[0519] While this disclosure has been described with reference to specific embodiments, those skilled in the art will understand that various modifications can be made without departing the scope of this disclosure, and that equivalents can be used in place of elements of this disclosure to address specific circumstances. Therefore, this disclosure is not intended to be limited to specific embodiments disclosed as the best mode contemplated for the implementation of this disclosure, but rather to include all embodiments that fall within the spirit and scope of the accompanying claims.

Claims

1. A method for treating verruca vulgaris in a subject requiring treatment for the verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency in an amount effective for the complete disappearance of the verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

2. The method according to claim 1, wherein the pharmaceutical composition is further effective in reducing the diameter of the common warts by at least 50% with a cumulative dose of one unit potency.

3. A method for treating verruca vulgaris in a subject requiring treatment for the verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 units potency, in an amount sufficient to cause complete disappearance of the verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and a secretory antigen.

4. The method according to claim 3, wherein the pharmaceutical composition is further capable of reducing the diameter of the common warts by at least 50% with a cumulative dose of one unit potency.

5. The method according to claim 1 or 3, wherein the complete disappearance is identified by observing that the common wart does not recur at the same site at least 20 weeks after administration of the first intralesional injection.

6. The method according to claim 1 or 3, wherein the complete disappearance is accompanied by the absence of scarring at the location of the common wart.

7. The method according to claim 1 or 3, wherein the complete disappearance is accompanied by a low level of depigmentation at the site of the common wart.

8. The method according to any one of claims 1 to 4, wherein, prior to the administration, the verruca vulgaris is between approximately 3 mm and approximately 20 mm in size.

9. The method according to any one of claims 1 to 4, wherein the administration is to provide an intra-focal injection to the subject.

10. The method according to claim 9, wherein the administration involves providing an intra-lesional injection near the edge of the common wart.

11. The method according to claim 9, wherein the administration is to provide an intra-lesional injection to the periphery of the common wart.

12. The method according to claim 9, wherein the administration is to provide an intrafocal injection within the verruca vulgaris.

13. The method according to any one of claims 1 to 4, wherein the administration provides two or more intralesional injections to the subject.

14. The method according to claim 13, wherein each of the two or more intralesional injections is delivered in a dose of at least 0.5 unit potency.

15. The method according to any one of claims 1 to 4, wherein the two or more intralesional injections are delivered to the subject over a single time period.

16. The method according to claim 15, wherein one of the two or more intralesional injections is delivered to the subject at intervals of approximately two weeks.

17. The method according to claim 15, wherein one of the two or more intralesional injections is delivered to the subject at intervals of approximately three weeks.

18. The method according to claim 15, wherein the two or more intralesional injections are delivered to the subject over a period of at least about eight weeks.

19. The method according to claim 13, wherein the two or more intralesional injections are delivered in two or more subgroups of intralesional injections over a single time period.

20. The method according to claim 19, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

21. The method according to claim 19 or 20, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

22. The method according to claim 19 or 20, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

23. The method according to claim 19 or 20, wherein the two or more subgroups of intralesional injections are delivered to the subject over a period of at least about eight weeks.

24. The method according to claim 19 or 20, wherein one of the two or more subgroups comprises two intralesional injections around the common wart.

25. The method according to claim 19 or 20, wherein one of the two or more subgroups comprises three intralesional injections around the common wart.

26. The method according to claim 19 or 20, wherein one of the two or more subgroups comprises four intralesional injections around the common wart.

27. The method according to claim 19 or 20, wherein one of the two or more subgroups comprises five injections around the common wart.

28. The method according to claim 19 or 20, wherein one of the two or more subgroups comprises six intralesional injections around the common wart.

29. The method according to any one of claims 24 to 28, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edges of the common warts.

30. The method according to any one of claims 24 to 28, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals along the edges of the common warts.

31. The method according to any one of claims 24 to 28, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

32. A method for treating verruca vulgaris in a subject requiring treatment for the verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial disappearance of the verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

33. The method according to claim 32, wherein the pharmaceutical composition is further effective in reducing the diameter of the common warts by at least 50% in a cumulative dose of one unit potency.

34. A method for treating verruca vulgaris in a subject requiring treatment for the verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of partially clearing the verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and a secretory antigen.

35. The method according to claim 34, wherein the pharmaceutical composition is further capable of reducing the diameter of the common warts by at least 50% with a cumulative dose of one unit potency.

36. The method according to claim 32 or 34, wherein the partial disappearance is identified by a reduction in the diameter of the wart.

37. The method according to any one of claims 32 to 35, wherein, prior to the administration, the verruca vulgaris is between approximately 3 mm and approximately 20 mm in size.

38. The method according to any one of claims 32 to 35, wherein the administration is to provide an intra-lesional injection to the subject.

39. The method according to claim 38, wherein the administration is to provide an intra-lesional injection near the edge of the common wart.

40. The method according to claim 38, wherein the administration is to provide an intralesional injection to the periphery of the common wart.

41. The method according to claim 38, wherein the administration is to provide an intrafocal injection within the verruca vulgaris.

42. The method according to any one of claims 32 to 35, wherein the administration provides two or more intralesional injections to the subject.

43. The method according to claim 42, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

44. The method according to any one of claims 32 to 35, wherein the two or more intralesional injections are delivered to the subject over a single time period.

45. The method according to claim 44, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

46. The method according to claim 44, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

47. The method according to claim 44, wherein the two or more intra-lesional injections are provided to the subject for at least about 18 weeks.

48. The method according to claim 42, wherein the two or more intralesional injections are delivered in two or more subgroups of intralesional injections over a single time period.

49. The method according to claim 48, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

50. The method according to claim 48 or 49, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

51. The method according to claim 48 or 49, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

52. The method according to claim 48 or 49, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about 18 weeks.

53. The method according to claim 48 or 49, wherein one of the two or more subgroups comprises two intralesional injections around the common wart.

54. The method according to claim 48 or 49, wherein one of the two or more subgroups comprises three intralesional injections around the common wart.

55. The method according to claim 48 or 49, wherein one of the two or more subgroups comprises four intralesional injections around the common wart.

56. The method according to claim 48 or 49, wherein one of the two or more subgroups comprises five injections around the common wart.

57. The method according to claim 48 or 49, wherein one of the two or more subgroups comprises six intralesional injections around the common wart.

58. The method according to any one of claims 52 to 57, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edges of the common warts.

59. The method according to any one of claims 52 to 57, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals along the edges of the common warts.

60. The method according to any one of claims 52 to 57, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

61. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for partial disappearance of said multiple verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

62. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount capable of partial disappearance of said multiple verruca vulgaris, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

63. The method according to claim 61 or 62, wherein the partial disappearance is identified by a reduction in the diameter of the wart.

64. The method according to claim 61 or 62, wherein the plurality of common warts comprises 3 to 20 common warts.

65. The method according to claim 61 or 62, wherein the plurality of common warts are located in the same anatomical position on the subject.

66. The method according to claim 61 or 62, wherein the administration is to provide an intra-lesional injection to the subject.

67. The method according to claim 61 or 62, wherein the administration provides two or more intralesional injections to the subject.

68. The method according to claim 67, wherein the two or more intralesional injections are delivered to the subject over a single time period.

69. The method according to claim 68, wherein one of the two or more intralesional injections is delivered to the subject at intervals of approximately two weeks.

70. The method according to claim 68, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

71. The method according to claim 68, wherein the two or more intralesional injections are provided to the subject for at least about 18 weeks.

72. The method according to claim 67, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

73. The method according to claim 61 or 62, further comprising identifying the largest common wart among the plurality of common warts.

74. The method according to claim 73, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

75. The method according to claim 73, wherein the administration is to provide an intra-lesional injection to the periphery of the largest common wart.

76. The method according to claim 73, wherein the administration is to provide an intra-lesional injection near the edge of the largest common wart.

77. The method according to claim 73, wherein the administration is to provide an intrafocal injection within the largest common wart.

78. The method according to claim 73, wherein the administration provides two or more intralesional injections to the largest common wart.

79. The method according to claim 78, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

80. The method according to claim 78 or 79, wherein the two or more intralesional injections are delivered to the subject over a single time period.

81. The method according to claim 80, wherein one of the two or more intralesional injections is delivered to the subject at intervals of approximately two weeks.

82. The method according to claim 80, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

83. The method according to claim 80, wherein the two or more intra-lesional injections are provided to the subject for at least about 18 weeks.

84. The method according to claim 78, wherein the two or more intralesional injections are delivered in two or more subgroups of intralesional injections over a single time period.

85. The method according to claim 84, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

86. The method according to claim 84 or 85, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

87. The method according to claim 84 or 85, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

88. The method according to claim 84 or 85, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about 18 weeks.

89. The method according to claim 84 or 85, wherein one of the two or more subgroups comprises two intralesional injections around the largest common wart.

90. The method according to claim 84 or 85, wherein one of the two or more subgroups comprises three intralesional injections around the largest common wart.

91. The method according to claim 84 or 85, wherein one of the two or more subgroups comprises four intralesional injections around the largest common wart.

92. The method according to claim 84 or 85, wherein one of the two or more subgroups comprises five injections around the largest common wart.

93. The method according to claim 84 or 85, wherein one of the two or more subgroups comprises six intralesional injections around the largest common wart.

94. The method according to any one of claims 89 to 93, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

95. The method according to any one of claims 89 to 93, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

96. The method according to any one of claims 89 to 93, wherein the intra-lesion injections within the subgroup are administered almost simultaneously.

97. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of one unit potency that is effective in reducing the diameter of each of the multiple verruca vulgaris by at least 50%, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

98. A method for treating multiple verruca vulgaris in a subject requiring treatment of said multiple verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in an amount capable of reducing the diameter of each of the multiple verruca vulgaris by at least 50% in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

99. The method according to claim 97 or 98, wherein the plurality of common warts comprises 3 to 20 common warts.

100. The method according to claim 97 or 98, wherein the plurality of common warts are located in the same anatomical location on the subject.

101. The method according to claim 97 or 98, wherein the administration is to provide an intra-lesional injection to the subject.

102. The method according to claim 97 or 98, wherein the administration involves providing two or more intralesional injections to the subject.

103. The method according to claim 102, wherein the two or more intralesional injections are provided to the subject over a single time period.

104. The method according to claim 103, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

105. The method according to claim 103, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

106. The method according to claim 102, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

107. The method according to claim 97 or 98, further comprising identifying the largest common wart among the plurality of common warts.

108. The method according to claim 107, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

109. The method according to claim 107, wherein the administration is to provide an intra-lesional injection to the periphery of the largest common wart.

110. The method according to claim 107, wherein the administration is to provide an intra-lesional injection near the edge of the largest common wart.

111. The method according to claim 107, wherein the administration is to provide an intrafocal injection within the largest common wart.

112. The method according to claim 107, wherein the administration provides two or more intralesional injections to the largest common wart.

113. The method according to claim 112, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

114. The method according to claim 112 or 113, wherein the two or more intralesional injections are provided to the subject over a single time period.

115. The method according to claim 114, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

116. The method according to claim 114, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

117. The method according to claim 112, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

118. The method according to claim 117, wherein each of the two or more subgroups of intralesional injections is delivered in a total dose of at least 0.5 unit potency.

119. The method according to claim 117 or 118, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

120. The method according to claim 117 or 118, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

121. The method according to claim 117 or 118, wherein the two or more subgroups of intra-lesional injections are delivered to the subject over a period of at least about two weeks.

122. The method according to claim 117 or 118, wherein one of the two or more subgroups comprises two intralesional injections around the largest common wart.

123. The method according to claim 117 or 118, wherein one of the two or more subgroups comprises three intralesional injections around the largest common wart.

124. The method according to claim 117 or 118, wherein one of the two or more subgroups comprises four intralesional injections around the largest common wart.

125. The method according to claim 117 or 118, wherein one of the two or more subgroups comprises five injections around the largest common wart.

126. The method according to claim 117 or 118, wherein one of the two or more subgroups comprises six intralesional injections around the largest common wart.

127. The method according to any one of claims 122 to 126, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

128. The method according to any one of claims 122 to 126, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

129. The method according to any one of claims 122 to 126, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

130. A method for treating non-verruca vulgaris in a subject requiring treatment for non-verruca vulgaris, the subject having one or more verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 unit potency in an amount effective for the complete disappearance of the non-verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

131. A method for treating non-verruca vulgaris in a subject requiring treatment for non-verruca vulgaris, the subject having one or more verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount sufficient to cause complete disappearance of the non-verruca vulgaris, wherein the pharmaceutical composition comprises Candida albicans and a filtered extract of a secretory antigen.

132. The method according to claim 130 or 131, wherein the non-ordinary wart is a plantar wart.

133. The method according to claim 130 or 131, wherein the non-ordinary wart is a genital wart.

134. The method according to claim 130 or 131, wherein the non-ordinary wart is a facial wart.

135. The method according to claim 130 or 131, wherein the non-ordinary wart is a flat wart.

136. The method according to claim 130 or 131, wherein the non-orious wart is a periungual wart.

137. The method according to claim 130 or 131, wherein the non-verrucae is located in the same anatomical region as one or more verrucae.

138. The method according to claim 130 or 131, wherein the complete disappearance is identified by observing that the non-plaque warts do not recur at the same site at least 20 weeks after administration of the first intralesional injection.

139. The method according to claim 130 or 131, wherein the administration is to provide an intra-lesional injection to the subject.

140. The method according to claim 130 or 131, wherein the administration involves providing two or more intralesional injections to the subject.

141. The method according to claim 140, wherein the two or more intralesional injections are provided to the subject over a single time period.

142. The method according to claim 141, wherein one of the two or more intralesional injections is administered to the subject at two-week intervals.

143. The method according to claim 141, wherein one of the two or more intralesional injections is administered to the subject at intervals of three weeks.

144. The method according to claim 141, wherein the two or more intra-lesional injections are delivered to the subject over a period of 27 weeks.

145. The method according to claim 140, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

146. The method according to claim 130 or 131, wherein the one or more common warts comprise 3 to 20 common warts.

147. The method according to claim 130 or 131, further comprising identifying the largest common wart among the one or more common warts.

148. The method according to claim 147, wherein, prior to the administration, the largest common wart is between approximately 3 mm and approximately 20 mm in size.

149. The method according to claim 147, wherein the administration is to provide an intrafocal injection to the periphery of the largest common wart.

150. The method according to claim 147, wherein the administration is to provide an intra-lesional injection near the edge of the largest common wart.

151. The method according to claim 147, wherein the administration is to provide an intrafocal injection within the largest common wart.

152. The method according to claim 147, wherein the administration provides two or more intralesional injections to the largest common wart.

153. The method according to claim 152, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

154. The method according to claim 152 or 153, wherein the two or more intralesional injections are provided to the subject over a single time period.

155. The method according to claim 154, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

156. The method according to claim 154, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

157. The method according to claim 154, wherein the two or more intra-lesional injections are provided to the subject for at least about 18 weeks.

158. The method according to claim 152, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

159. The method according to claim 158, wherein one subgroup within the two or more subgroups of intralesional injections is delivered in a total dose of at least 0.5 unit potency.

160. The method according to claim 158 or 159, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

161. The method according to claim 158 or 159, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

162. The method according to claim 158 or 159, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about 18 weeks.

163. The method according to claim 158 or 159, wherein one of the two or more subgroups comprises two intralesional injections around the largest common wart.

164. The method according to claim 158 or 159, wherein one of the two or more subgroups comprises three intralesional injections around the largest common wart.

165. The method according to claim 158 or 159, wherein one of the two or more subgroups comprises four intralesional injections around the largest common wart.

166. The method according to claim 158 or 159, wherein one of the two or more subgroups comprises five injections around the largest common wart.

167. The method according to claim 158 or 159, wherein one of the two or more subgroups comprises six intralesional injections around the largest common wart.

168. The method according to any one of claims 163 to 167, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals around the edge of the largest common wart.

169. The method according to any one of claims 163 to 167, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edge of the largest common wart.

170. The method according to any one of claims 163 to 167, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

171. A method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency in an amount effective for the complete disappearance of said previously treated verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

172. A method for treating previously treated verruca vulgaris in a subject requiring treatment of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 5 units potency, in an amount capable of completely clearing the previously treated verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

173. The method according to claim 171 or 172, wherein the previously treated verruca vulgaris is a verruca vulgaris that was previously treated with cryotherapy.

174. The method according to claim 173, wherein the previously treated verruca vulgaris did not respond to the cryotherapy.

175. The method according to claim 173, wherein the cryotherapy did not completely eliminate the previously treated verruca vulgaris.

176. The method according to claim 171 or 172, wherein the previously treated verruca vulgaris is a verruca vulgaris that was previously treated with salicylic acid or a related acid.

177. The method according to claim 176, wherein the related acid is trichloroacetic acid or bichloroacetic acid.

178. The method according to claim 176, wherein the previously treated verruca vulgaris did not respond to the salicylic acid or related acid.

179. The method according to claim 176, wherein the salicylic acid or related acid did not completely eliminate the previously treated verruca vulgaris.

180. The method according to claim 171 or 172, wherein the previously treated verruca vulgaris is a verruca vulgaris that has been previously treated with a treatment selected from the group consisting of liquid nitrogen, carbon dioxide, cantharidin, simple occlusion, verruca gel, apple cider vinegar, surgery, laser, tea tree oil, cryotherapy verruca spray, verruca curettage, electrocautery, lavender and oregano essential oils, and imiquimod.

181. The method according to claim 180, wherein the previously treated verruca vulgaris did not respond to the treatment.

182. The method according to claim 180, wherein the treatment did not completely eliminate the previously treated verruca vulgaris.

183. The method according to any one of claims 171 to 182, wherein, prior to the administration, the previously treated common warts are between approximately 3 mm and approximately 20 mm in size.

184. The method according to any one of claims 171 to 182, wherein the complete disappearance is identified by observing that the previously treated verruca vulgaris does not recur at the same site at least 20 weeks after administration of the first intralesional injection.

185. The method according to any one of claims 171 to 182, wherein the complete disappearance is accompanied by the absence of scarring at the location of the previously treated verruca vulgaris.

186. The method according to any one of claims 171 to 182, wherein the complete disappearance is accompanied by a low level of depigmentation at the site of the previously treated verruca vulgaris.

187. The method according to any one of claims 171 to 182, wherein the administration is to provide an intra-focal injection to the subject.

188. The method according to claim 187, wherein the administration is to provide an intrafocal injection at the periphery of the previously treated common wart.

189. The method according to claim 187, wherein the administration is provided as an intrafocal injection near the periphery of the previously treated common wart.

190. The method according to claim 187, wherein the administration is to provide an intrafocal injection within the previously treated common wart.

191. The method according to any one of claims 171 to 182, wherein the administration provides two or more intralesional injections to the subject.

192. The method according to claim 191, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

193. The method according to claim 191 or 192, wherein the two or more intralesional injections are provided to the subject over a single time period.

194. The method according to claim 193, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

195. The method according to claim 193, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

196. The method according to claim 193, wherein the two or more intra-lesional injections are provided to the subject for at least about 18 weeks.

197. The method according to claim 191, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

198. The method according to claim 197, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

199. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

200. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

201. The method according to claim 197 or 198, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about 18 weeks.

202. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups comprises two intralesional injections around the previously treated verruca vulgaris.

203. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups comprises three intralesional injections around the previously treated verruca vulgaris.

204. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups comprises four intralesional injections around the previously treated verruca vulgaris.

205. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups comprises five injections around the previously treated verruca vulgaris.

206. The method according to claim 197 or 198, wherein one subgroup within the two or more subgroups comprises six intralesional injections around the previously treated verruca vulgaris.

207. The method according to any one of claims 202 to 206, wherein the intralesional injections within the subgroup are arranged at substantially equal intervals along the margins of the previously treated common warts.

208. The method according to any one of claims 202 to 206, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edges of the previously treated common warts.

209. The method according to any one of claims 202 to 206, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

210. A method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intralesional injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount effective in delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

211. A method for delaying the recurrence of verruca vulgaris in a subject requiring delay in the recurrence of said verruca vulgaris, comprising administering to the subject one or more intrafocal injections of a pharmaceutical composition in a cumulative dose of 2.5 unit potency, in an amount capable of delaying the reappearance of said verruca vulgaris at the time of disappearance of said verruca vulgaris, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

212. The method according to claim 210 or 211, wherein the subject does not develop any new verruca vulgaris within at least 16 weeks after the last injection of the one or more intralesional injections.

213. The method according to claim 210 or 211, wherein the subject does not develop any new verruca vulgaris within the same anatomical region as the verruca vulgaris.

214. The method according to claim 210 or 211, wherein the subject does not develop any new verruca vulgaris in the same area as the verruca vulgaris.

215. The method according to claim 210 or 211, wherein, prior to the administration, the verruca vulgaris is between approximately 3 mm and approximately 20 mm in size.

216. The method according to claim 210 or 211, wherein the administration is to provide an intra-lesional injection to the subject.

217. The method according to claim 216, wherein the administration is to provide an intra-lesional injection to the periphery of the common wart.

218. The method according to claim 216, wherein the administration is to provide an intra-focal injection near the edge of the common wart.

219. The method according to claim 216, wherein the administration is to provide an intrafocal injection within the verruca vulgaris.

220. The method according to claim 210 or 211, wherein the administration provides two or more intralesional injections to the subject.

221. The method according to claim 220, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

222. The method according to claim 220 or 221, wherein the two or more intralesional injections are provided to the subject over a single time period.

223. The method according to claim 222, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

224. The method according to claim 222, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

225. The method according to claim 222, wherein the two or more intra-lesional injections are provided to the subject for at least about eight weeks.

226. The method according to claim 220, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

227. The method according to claim 226, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

228. The method according to claim 226 or 227, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

229. The method according to claim 226 or 227, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

230. The method according to claim 226 or 227, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about eight weeks.

231. The method according to claim 226 or 227, wherein one of the two or more subgroups comprises two intralesional injections around the common wart.

232. The method according to claim 226 or 227, wherein one of the two or more subgroups comprises three intralesional injections around the common wart.

233. The method according to claim 226 or 227, wherein one of the two or more subgroups comprises four intralesional injections around the common wart.

234. The method according to claim 226 or 227, wherein one of the two or more subgroups comprises five injections around the common wart.

235. The method according to claim 226 or 227, wherein one of the two or more subgroups comprises six intralesional injections around the common wart.

236. The method according to any one of claims 231 to 235, wherein the intra-lesional injections within the subgroup are arranged at substantially equal intervals along the periphery of the common wart.

237. The method according to any one of claims 231 to 235, wherein the intralesional injections within the subgroup are arranged at approximately equal intervals near the edges of the common warts.

238. The method according to any one of claims 231 to 235, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

239. The method according to any one of claims 1 to 238, wherein the pharmaceutical composition comprises at least 80% mannose.

240. The method according to any one of claims 1 to 239, wherein the pharmaceutical composition comprises at least 8% glucose.

241. The method according to any one of claims 1 to 240, wherein the pharmaceutical composition comprises at least 1% galactose.

242. The method according to any one of claims 1 to 240, wherein the antigen has a molecular weight of about 167 kilodaltons.

243. The method according to any one of claims 1 to 241, wherein the subject is between 18 and 65 years of age.

244. The method according to any one of claims 1 to 243, wherein the subject was diagnosed with a first common verruca at least 12 weeks prior to receiving the one or more intralesional injections.

245. The method according to any one of claims 1 to 244, wherein the subject was not diagnosed with intractable verruca.

246. The method according to any one of claims 1 to 245, wherein the subject has a baseline result between 5 mm and 25 mm for a delayed-type hypersensitivity test.

247. The method according to any one of claims 1 to 246, wherein the subject has not been diagnosed with a systemic disease that impairs immune function.

248. The method according to any one of claims 1 to 246, wherein the subject has not been diagnosed with a localized disease that impairs immune function.

249. The method according to any one of claims 1 to 246, wherein the subject has not been diagnosed with a systemic condition that impairs immune function.

250. The method according to any one of claims 1 to 246, wherein the subject has not been diagnosed with a localized condition that impairs immune function.

251. The method according to any one of claims 1 to 246, wherein the subject has not been diagnosed with psoriasis.

252. The method according to any one of claims 1 to 251, wherein the subject has not received treatment that causes an immunosuppressed state.

253. The method according to any one of claims 1 to 252, wherein the subject has not been diagnosed with diabetes.

254. The method according to any one of claims 1 to 253, wherein the subject does not have a history of keloid formation.

255. The method according to any one of claims 1 to 254, wherein the subject does not have a pre-existing dermatological condition in the same anatomical region as the wart being treated.

256. The method according to any one of claims 1 to 255, wherein the subject does not have an underlying inflammatory state.

257. The method according to claim 256, wherein the underlying inflammatory state is an arthritis-affected joint.

258. The method according to any one of claims 1 to 257, wherein the subject has not received one or more treatments selected from the group consisting of liquid nitrogen, carbon dioxide, electrolysis, laser, surgery, simple occlusion, salicylic acid, trichloroacetic acid, bichloroacetic acid, OTC drugs, and cantharidin within four weeks prior to the administration.

259. The method according to any one of claims 1 to 258, wherein the subject has not received one or more immunotherapies selected from the group consisting of diphenylcyclopropenone (DPCP), dinitrochlorobenzene (DNCB), imiquimod, 5-fluorouracil, bleomycin, and podophyllin within 12 weeks prior to the administration.

260. The method according to any one of claims 1 to 259, wherein the subject has not received one or more systematic treatments selected from the group consisting of cimetidine, zinc supplements in doses higher than 20 mg of elemental zinc per day, azathioprine, 6-mercaptopurine, methotrexate, infliximab, adalimumab, etanercept, and steroids within 12 weeks prior to the administration.

261. The method according to any one of claims 1 to 260, wherein the subject has not received any investigational drug within 30 days prior to the administration.

262. The method according to any one of claims 1 to 260, wherein the subject has not received any of the investigational drugs within five half-lives of the investigational drug prior to the administration.

263. A pharmaceutical product comprising Candida albicans and a filtered extract of secretory antigens, formulated to completely eliminate common warts at a cumulative dose of 2.5 units potency.

264. A pharmaceutical product comprising Candida albicans and a filtered extract of secretory antigens, formulated to partially eliminate verruca vulgaris at a cumulative dose of 5 units of potency.

265. A pharmaceutical product comprising Candida albicans and a filtered extract of a secretory antigen, formulated to reduce the diameter of a common wart by at least 50% with a cumulative dose of one unit potency.

266. A pharmaceutical product comprising Candida albicans and a filtered extract of secretory antigens, formulated to partially eliminate multiple verruca vulgaris at a cumulative dose of 5 units potency.

267. A pharmaceutical product comprising Candida albicans and a filtered extract of a secretory antigen, formulated to reduce the diameter of multiple common warts by at least 50% with a cumulative dose of one unit potency.

268. A pharmaceutical product comprising a filtered extract of Candida albicans and secretory antigens, formulated to completely eliminate non-common warts at a cumulative dose of 5 units potency.

269. A pharmaceutical product comprising a filtered extract of Candida albicans and secretory antigens, formulated to completely eliminate previously treated verruca vulgaris at a cumulative dose of 5 units potency.

270. A pharmaceutical product comprising Candida albicans and a filtered extract of a secretory antigen, formulated to delay the reappearance of common warts at a cumulative dose of 2.5 units of potency upon the disappearance of the common warts.

271. The pharmaceutical product according to any one of claims 263 to 270, wherein the pharmaceutical product comprises at least 80% mannose.

272. The pharmaceutical product according to any one of claims 263 to 270, wherein the pharmaceutical product comprises at least 8% glucose.

273. The pharmaceutical product according to any one of claims 263 to 270, wherein the pharmaceutical product comprises at least 1% galactose.

274. The pharmaceutical product according to any one of claims 263 to 270, wherein the antigen has a molecular weight of about 167 kilodaltons.

275. The pharmaceutical product according to any one of claims 263 to 274, wherein the pharmaceutical product is formulated in a vial.

276. The pharmaceutical product according to claim 275, wherein the vial is a multi-dose storage vial.

277. The pharmaceutical product according to claim 275, wherein the vial is a single-dose, non-storage vial.

278. The pharmaceutical product according to claim 275, wherein the vial is a glass vial.

279. The pharmaceutical product according to claim 278, wherein the glass vial is a 2 mL vial.

280. The pharmaceutical product according to any one of claims 263 to 273, wherein the pharmaceutical product is formulated in a pre-filled syringe.

281. The pharmaceutical product according to claim 280, wherein the pre-filled syringe has a volume of 0.5 mL.

282. A method for reducing IL-23 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of one volume of a pharmaceutical composition in a cumulative dose of one unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

283. The method according to claim 282, wherein, upon receiving the cumulative dose, the level of IL-23 in the subject is reduced by at least about 15% compared to the level of IL-23 measured in the subject before the administration.

284. A method for the complete elimination of verruca vulgaris in a subject requiring the complete elimination of said verruca vulgaris, comprising reducing the level of IL-23 in the subject requiring the complete elimination of said verruca vulgaris by at least about 35%.

285. The method according to claim 284, wherein the reduction is achieved by administering to the subject one or more intrafocal injections of one amount of a pharmaceutical composition in a cumulative dose of 3 units potency, the pharmaceutical composition comprising a filtered extract of Candida albicans and a secretory antigen.

286. The method according to claim 284, wherein the complete disappearance is identified by observing that the common wart does not recur at the same site at least 20 weeks after the reduction.

287. A method for reducing IL-7 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of a single volume of a pharmaceutical composition in a cumulative dose of 0.6 unit potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

288. The method according to claim 287, wherein, upon receiving the cumulative dose, the level of IL-7 in the subject is reduced by at least about 10% compared to the level of IL-7 measured in the subject before administration.

289. A method for reducing IL-7 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of a single volume of a pharmaceutical composition in a cumulative dose of 3 units potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

290. The method according to claim 289, wherein, upon receiving the cumulative dose, the level of IL-7 in the subject is reduced by at least about 20% compared to the level of IL-7 measured in the subject before administration.

291. A method for reducing IP-10 levels in a subject diagnosed with verruca vulgaris, comprising administering to the subject one or more intra-lesional injections of a single volume of a pharmaceutical composition in a cumulative dose of 3 units potency, wherein the pharmaceutical composition comprises a filtered extract of Candida albicans and secretory antigens.

292. The method according to claim 291, wherein, upon receiving the cumulative dose, the level of IP-10 in the subject is reduced by at least about 5% compared to the level of IP-10 measured in the subject before administration.

293. The method according to any one of claims 282, 283, and 285-292, wherein the administration is to provide an intra-focal injection to the subject.

294. The method according to claim 293, wherein the administration is to provide an intra-lesional injection near the edge of the common wart.

295. The method according to claim 293, wherein the administration is to provide an intralesional injection to the periphery of the common wart.

296. The method according to claim 293, wherein the administration is to provide an intrafocal injection within the verruca vulgaris.

297. The method according to any one of claims 282, 283, and 285-292, wherein the administration provides two or more intralesional injections to the subject.

298. The method according to claim 297, wherein each of the two or more intralesional injections is provided in a dose of at least 0.5 unit potency.

299. The method according to any one of claims 282, 283, 285-292, wherein the two or more intralesional injections are delivered to the subject over a single time period.

300. The method according to claim 299, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately two weeks.

301. The method according to claim 299, wherein one of the two or more intralesional injections is provided to the subject at intervals of approximately three weeks.

302. The method according to claim 299, wherein the two or more intra-lesional injections are provided to the subject for at least about eight weeks.

303. The method according to claim 297, wherein the two or more intralesional injections are provided in subgroups of two or more intralesional injections over a single time period.

304. The method according to claim 303, wherein one subgroup within the two or more subgroups of intralesional injections provides a total dose of at least 0.5 unit potency.

305. The method according to claim 303 or 304, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately two weeks.

306. The method according to claim 303 or 304, wherein one subgroup within the two or more subgroups of intralesional injections is provided to the subject at intervals of approximately three weeks.

307. The method according to claim 303 or 304, wherein two or more subgroups of intra-focal injections are provided to the subject for at least about eight weeks.

308. The method according to claim 303 or 304, wherein one of the two or more subgroups comprises two intralesional injections around the common wart.

309. The method according to claim 303 or 304, wherein one of the two or more subgroups comprises three intralesional injections around the common wart.

310. The method according to claim 303 or 304, wherein one of the two or more subgroups comprises four intralesional injections around the common wart.

311. The method according to claim 303 or 304, wherein one of the two or more subgroups comprises five injections around the verruca vulgaris.

312. The method according to claim 303 or 304, wherein one of the two or more subgroups comprises six intralesional injections around the common wart.

313. The method according to any one of claims 308 to 312, wherein the intra-lesional injections within the subgroup are arranged at approximately equal intervals near the edges of the common warts.

314. The method according to any one of claims 308 to 312, wherein the intra-lesional injections within the subgroup are arranged at substantially equal intervals along the periphery of the common wart.

315. The method according to any one of claims 308 to 312, wherein the intra-lesional injections within the subgroup are administered almost simultaneously.

316. The method according to any one of claims 1 to 262 and 282 to 315, wherein the pharmaceutical composition comprises a filtered extract of two strains of Candida albicans and a secretory antigen.

317. The method according to claim 316, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number PTA-126019.

318. The method according to claim 316, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number ATCC-10231.

319. The method according to any one of claims 316 to 318, wherein a representative sample of the second of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number PTA-126020.

320. The pharmaceutical product according to any one of claims 263 to 281, wherein the filtered extract of Candida albicans comprises two strains of Candida albicans.

321. The pharmaceutical product according to claim 320, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number PTA-126019.

322. The pharmaceutical product according to claim 320, wherein a representative sample of the first of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number ATCC-10231.

323. A pharmaceutical product according to any one of claims 320 to 322, wherein a representative sample of the second of the two strains of Candida albicans is deposited with the ATCC under ATCC accession number PTA-126020.

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