Disulfide bond donation and exchange as opportunity for viral degradation

Abstract

Compositions and methods for treating a viral condition. The composition is administered to the subject in a therapeutic amount. The composition includes a first medicament effective for up-regulating disulfide bond donation and exchange, and a second medicament comprising a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, an intron splicer, or combinations thereof. The first medicament is effective for causing viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds. The second medicament is effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins. The virus is Coronavirus, Epstein Barr virus, human papillomavirus, or herpes simplex virus.

Description

DISULFIDE BOND DONATION AND EXCHANGE AS OPPORTUNITYFOR VIRAL DEGRADATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 63 / 571,604 filed March 29, 2024, the specification(s) of which is / are incorporated herein in their entirety by reference.FIELD OF THE INVENTION

[0002] The present invention features an unusual benefit resulting from the encouragement of viral disulfide bond donation and exchange that can render a viral particle vulnerable to degradation.BACKGROUND OF THE INVENTION

[0003] Disulfide bonds, created via isomerase reactions and defined simply as covalent bonds between sulfur ions within thiol groups, are a necessary component of proteins. With proper building and creation of disulfide bonds, both eukaryotic cells and viruses experience overall structural support. There are many ways by which disulfide bonds may be introduced into a eukaryotic cell or virus, such as, but not limited to, the donation of thiol groups via glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, and protein disulfide isomerases. Keratins, which contain high levels of disulfide bonds, may also be a source of disulfide bonds for a eukaryotic cell or virus.

[0004] Generally, eukaryotic cells utilize disulfide bonds for protein structure, cell stabilization, and cell-to-cell signaling. Without disulfide bonds within proteins, normal cell structure cannot be maintained and may lead to cell degradation or abnormal cell-to-cell signaling. The endoplasmic reticulum (ER) manufactures proteins rich in disulfide bonds but it can only do so with ATP provided by the mitochondria. The mitochondria operate best to produce ATP with low cell oxidative stress levels and rely on inherent cellular processes for this. The iron cycle, for example, is a eukaryotic cell process that supports low oxidative stress load.

[0005] The process of using disulfide bonds is generally a donation and exchange of disulfide bonds via isomerase reactions. This donation and exchange of disulfide bonds has additional benefits for the eukaryotic cell, such as potentiating dissociation of p53 from the attachment point on the DNA. Sulfhydryl oxidase is the enzyme that regulates this process. Withdissociation, p53 can then be active within the cell to regulate apoptosis.

[0006] Within viruses such as Epstein Barr (EBV) or Human Papilloma (HPV), disulfide bonds are used to strengthen viral proteins such as those essential for capsids. For example, HPV uses disulfide bonds to build the infective and oncogenic E6 / 7 proteins. The E6 / 7 proteins are also necessary for infectivity of the host eukaryotic cell. With infectivity of the cell, HPV can control host cell machinery such as p53 and DNA repair proteins. Control of host cell mechanics provides an opportunity for viral potentiation of cancerous conditions, such as, but not limited to, breast or cervical cancers.

[0007] Viruses also utilize host cell mechanics and normal processes such as p53 or DNA repair proteins to potentiate inflammation (generally via Nf-kB, TNF, and IL-6) and oxidative stress (such as NOX). Potentiation of inflammation and oxidative stress by viruses may be accentuated by host cell gene polymorphisms, in particular, those that would normally regulate interleukin responses (such as IL-6), the iron cycle (such as HFE / TFR2), glutamine (such as GAD1 / SLC17A7), mitochondrial functionality (such as PPARGC1A / TCF7L2), and methylation (such as MTHFR / MTRR / MTR).

[0008] Human host cells have innate cellular mechanics designed to aid in viral degradation and elimination. These processes include, but are not limited to, SLICER and DICER (within the RNA interference process), apoptosis (via p53), RNA degradation (such as deadenylation), and intron splicing (with Group II introns).

[0009] Viruses, however, have strategies to overcome degradation. They are able to overcome degradation by controlling host cell mechanics, such as host DNA repair processes, apoptosis, inflammatory’ responses, oxidative stress levels, and immune cell responses. Integration into a host cell is another strategy viruses employ to overcome degradation. EBV, for example, integrates within B or endothelial cells. HPV integrates within the host chromosome. In 2007, the IRAC Working Group on the Evaluation of Carcinogenic Risks to Humans Monograph reported HPV integration at 190 loci, confirming random distribution "‘over the whole genome".

[0010] Hence, there is a need for novel formulations and treatments that can cause viruses to dissociate from integration loci and allow for degradation of said viruses by drug medicaments.BRIEF SUMMARY OF THE INVENTION

[0011] It is an objective of the present invention to provide compositions and methods that cantreat viral diseases, as specified in the independent claims. Embodiments of the invention are given in the dependent claims. Embodiments of the present invention can be freely combined with each other if they are not mutually exclusive.

[0012] According to some embodiments, the present invention features a composition for treating a viral condition. The composition may comprise a first medicament effective for up-regulating disulfide bond donation and exchange, and a second medicament comprising a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, an intron splicer, or combinations thereof. Without wishing to limit the present invention, the first medicament is effective for causing viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds. In some embodiments, the second medicament is effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.

[0013] According to other embodiments, the composition for treating a viral condition may comprise a first medicament that contains disulfide bonds, and a second medicament effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins. The first medicament may comprise an active agent that comprises said disulfide bonds.

[0014] According to some other embodiments, the composition for treating a viral condition may comprise a first medicament that contains disulfide bonds, and a second medicament effective for enhancing the disulfide bond effect that causes dissociation and replication of viruses. The first medicament may comprise an active agent that comprises said disulfide bonds. In a non-limiting embodiment, the first medicament may comprise an herbal preparation of Sarracenia flava that contains disulfide bonds. In a non-limiting embodiment, the second medicament comprises magnesium. Magnesium can enhance the disulfide bond effect that causes the virus to dissociate and replicate.

[0015] Without wishing to limit the present invention, administration of said composition provided a surprising result. For example, only when Sarracenia flava and magnesium were administered together, the disulfide bond effect on the virus was further enhanced by magnesium. Table 1 in the description showed that there was a disulfide effect with Sarracenia flava alone in a bath soak, and the symptoms worsened when magnesium was added.

[0016] In other embodiments, the composition for treating a viral condition may comprise one or more omega-3 fatty acids, and an herbal preparation of Sarracenia flava, Sarracenia purpurea, Sarracenia alata, or mixed hybrids thereof, said herbal preparation containing disulfide bonds. In some embodiments, the omega-3 fatty acids are a-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA).

[0017] In conjunction with the embodiments described herein, the viral condition is cervical dysplasia, cervical cancer, Covid- 19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection. However, the present invention is not limited to said viral infections, and may be used to treat other viral conditions.

[0018] According to other embodiments, the present invention features a method of treating a viral condition in a subject in need thereof. The method may comprise administering to the subject a therapeutic amount of any of the compositions described herein. In some embodiments, the composition may be administered orally, topically, intravenously, intramuscularly, or subcutaneously.

[0019] According to some embodiments, the present invention features a kit for treating a viral condition. In some embodiments, the kit may comprise a first medicament effective for up-regulating disulfide bond donation and exchange; a second medicament comprising one or more of the following: a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, or an intron splicer; and instructions for administering the first and second medicaments to a subject in need of such treatment.

[0020] According to other embodiments, the present invention features a kit for detecting a virus. The kit may comprise an active agent that contains disulfide bonds or is effective for up-regulating disulfide bond donation and exchange; and instructions for testing a sample to detect the virus.

[0021] In conjunction with the compositions and methods described herein, the first medicament may comprise glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, keratins, or a combination thereof. In other embodiments, the DNA / RNA inhibitor is Actinomycin D, Remdesivir, Mithramycin A, Azidothymidine, Aphidicolin, Acyclovir, Entecavir, Favipiravir, Galidesivir. Rilpivirine, Risdiplam, Tenofovir, or a combination thereof. In some other embodiments, the DNA polymerase is Abacavir, Adefovir,Cidofovir, Entecavir, Famciclovir, Foscamet, Emticitabine, Entecavir, Lamivudine, Stavudine, Telbivudine, Tenofovir, or a combination thereof.

[0022] In some embodiments, the protease inhibitor is Amprenavir, Atazanavir, Darunavir, Fosamprenavir . Indinavir, Lopinavir, Nelfinavir, Ritonavir, or a combination thereof. In other embodiments, the intron splicer is maturase enzymes. In a non-limiting embodiment, the second medicament comprises iron bisglycinate, magnesium, ascorbic acid, DHS, pyruvate, a methyltransferase inhibitor, or a combination thereof. In some embodiments, the methyltransferase inhibitor is celery root.

[0023] In some embodiments, the first medicament may be administered orally, topically, intravenously, intramuscularly, subcutaneously vaginally, rectally, sublingually, intranasally, or by injection. In other embodiments, the second medicament may be administered orally, topically, intravenously, intramuscularly, subcutaneously vaginally, rectally, sublingually, intranasally, or by injection. In some other embodiments, the first medicament and the second medicament are administered at the same time or at different times.

[0024] Without wishing to limit the present invention to a particular theory or mechanism, potentiation of disulfide bond building performed by sulfhydryl oxidase (as from addition of thiols groups via glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, or keratins) via isomerase reactions within the host eukary otic cell may inadvertently result in an increase in viral load. This phenomenon would occur as a result of viral use of disulfide bonds alongside host cell use. As a result, there would be a potential for a virus such as HPV to trend towards replication when liberated from integrated sites. Liberation of a virus (such as HPV) from integrated sites would occur as a result from the presence of disulfide bonds and therefore sulfhydryl oxidase. An actively replicating (and non-integrated) virus would be vulnerable and sensitive to intron splicing, DNA / RNA degradation, polymerase inhibition, and / or protease inhibition.

[0025] Host cells may require support to degrade, slice, or inhibit viral RNA, DNA, and proteins. Drug products can aid in controlling or regulating viral levels. Examples of said drug medicaments include, but are not limited to, DNA polymerase inhibitors (such as valacyclovir), protease inhibitors (such as Ritonavir), RNA inhibitors (such as Remdesivir), and Group II intron splicers (such as Maturase enzymes). Treatments such as ablation, cryosurgery, or biopsy can remove tissues damaged by viruses. These treatments may particularly be important for patientswith gene polymorphisms, such as HFE-C282Y, which is a known risk factor for cervical cancer. In some embodiments, the viral treatment is for treating conditions such as, but not limited to, cervical dysplasia, cervical cancer, Covid- 19, EBV, EISV, HPV, etc. However, the present invention is not limited to said viral infections, and may be used to treat other viral conditions.

[0026] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.DETAILED DESCRIPTION OF THE INVENTION

[0027] Although embodiments of the disclosure have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and / or uses and obvious modifications and equivalents thereof. Moreover, while a number of variations have been shown and described in varying detail, other modifications, which are within the scope of the present disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described herein.

[0028] Disclosed are the various compounds, solvents, solutions, carriers, and / or components to be used to prepare the compositions to be used within the methods disclosed herein. Also disclosed are the various steps, elements, amounts, routes of administration, symptoms, and / or treatments that are used or observed when performing the disclosed methods, as well as the methods themselves. These and other materials, steps, and / or elements are disclosed herein, and it is understood that when combinations, subsets, interactions, groups, etc. of these materials are disclosed, while specific reference of each various individual and collective combination andpermutation of these compounds may not be explicitly disclosed, each is specifically contemplated and described herein.

[0029] Unless otherwise explained, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which a disclosed invention belongs. The singular terms "a," "an," and "the" include plural referents unless context clearly indicates otherwise. Similarly, the word "or" is intended to include "and" unless the context clearly indicates otherwise. The term "comprising" means that other elements can also be present in addition to the defined elements presented. The use of "comprising" indicates inclusion rather than limitation. Stated another way, the term "comprising" means "including principally, but not necessarily solely". Furthermore, variations of the word "comprising", such as "comprise" and "comprises", have correspondingly the same meanings. In one respect, the technology described herein related to the herein described compositions, methods, and respective component(s) thereof, as essential to the invention, yet open to the inclusion of unspecified elements, essential or not ("comprising").

[0030] Suitable methods and materials for the practice and / or testing of embodiments of the disclosure are described below. Such methods and materials are illustrative only and are not intended to be limiting. Other methods and materials similar or equivalent to those described herein can be used.

[0031] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety for all purposes. In case of conflict, the present specification, including explanations of terms, will control.

[0032] Although methods and materials similar or equivalent to those described herein can be used to practice or test the disclosed technology, suitable methods and materials are described below. The materials, methods, and examples are illustrative only and not intended to be limiting.

[0033] As used herein, the terms ”% wt” and ”% w / v” can be used interchangeably and are defined as a % concentration of unit weight or mass to unit volume. For example, a % w / v may refer to a concentration in g / ml. As used herein, the terms “% vol”, “% vol / vol” and “% v / v” can be used interchangeably and refer to a volume percentage of a component relative to the total volume of the solution or mixture. For example, 5% vol of component A may refer to 5 ml of component A to 100 ml of total volume of the mixture.

[0034] As known to one of ordinary skill in the art, a “carnivorous plant” is a predatory plant that obtains its nutrients by trapping and killing prey (International Carnivorous Plant Society, www.camivorousplants.org). A carnivorous plant has the following features: 1. the plant captures and kills prey; 2. the plant has some mechanism to digest the prey; and 3. the plant absorbs the nutrients from the prey. Some non-limiting examples of carnivorous plants include species from the genus Sarracenia. Nepenthes, Dionaea, Utricularia. Heliamphora, Cephalotus, and Drosera. The preferred carnivorous plants of the present invention are pitcher plants, namely, Sarracenia flava, Sarracenia purpurea, and Sarracenia alata. Since these plants can readily interbreed, the carnivorous plants can include hybrids thereof.

[0035] As used herein, the term “extract” is defined as a separation of the beneficial (medicinal) components, e.g. disulfide bonds, from the fibrous, less useful part of the plant. Extracts can be in a liquid, gel, or powdered form.

[0036] As used herein, the term “infuse” is defined as a procedure of withdrawing nutritive compounds of a plant into a medium, and allowing them to linger in the medium for a period of time to allow for the transfer of herbal extracts into the medium. An “infused solution” is the resulting solution with the nutritive compounds.

[0037] As used herein, an “herbal preparation” or a “plant preparation” may be an extract, tincture, or infused solution made or prepared from an herb or plant. The herbal preparation contains active components, e.g. disulfide bonds, from the herb or plant.

[0038] As used herein, “omega oils” are essential fatty acids that are polyunsaturated fatty acids (PUFAs). They are needed for various cellular metabolic processes and for the maintenance and function of tissues and organs. Examples of omega oils include omega-3, omega-6, and omega-9. The omega-3 fatty acids are a-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA).

[0039] As used herein, the term “supplement” is generally understood to include, but is not limited to, vitamins, minerals, fiber, fatty acids, amino acids, and amine derivatives.

[0040] As used herein, the term “minerals" may be categorized into two kinds of minerals: macrominerals and trace minerals. Macrominerals include, but are not limited to, calcium, phosphorus, magnesium, sodium, potassium, chloride and sulfur. Trace minerals include, but are not limited to, iron, manganese, copper, iodine, zinc, cobalt, fluoride and selenium.

[0041] Examples of vitamins include, but are not limited to. retinoic acid (Vitamin A). Vitamin B3 in the form of niacin (nicotinic acid), niacinamide (nicotinamide) or inositol hexanicotinate, folic acid or folate, vitamin B-complex, vitamin C, vitamin D, vitamin E, and vitamin K. Non-limiting examples of fatty acids include phosphocholine, phosphatidylcholine, and phosphatidylserine.

[0042] Subject / Patient

[0043] A “subject'’ is an individual and includes, but is not limited to, a mammal (e.g., a human, horse, pig, rabbit, dog. sheep, goat, non-human primate, cow, cat, guinea pig, or rodent), a fish, a bird, a reptile or an amphibian. The term does not denote a particular age or sex. Thus, adult and newborn subjects, as well as fetuses, whether male or female, are intended to be included. A “patient” is a subject afflicted with a disease or disorder. The term “patient” includes human and veterinary subjects.

[0044] As used herein, the terms “subject” and “patient” are used interchangeably. As used herein, a subject can be a mammal such as a non-primate (e.g., cows, pigs, horses, cats, dogs, rats, etc.) or a primate (e.g., monkey and human). In specific embodiments, the subject is a human. In one embodiment, the subject is a mammal (e.g., a human) having a disease, disorder or condition described herein. In another embodiment, the subject is a mammal (e g., a human) at risk of developing a disease, disorder or condition described herein. In certain instances, the term patient refers to a human.

[0045] In one embodiment, a “patient” is a subject afflicted with a disease or disorder. In certain instances, the term patient refers to a human.

[0046] "Subject," "individual," "host," "animal." and "patient" are used interchangeably herein to refer to mammals, including, but not limited to, rodents, simians, humans, felines, canines, equines, bovines, porcines, ovines, caprines, mammalian laboratory animals, mammalian farm animals, mammalian sport animals, and mammalian pets.

[0047] Treatments

[0048] As used herein, the terms "treat," “treating,” or "treatment" refer to both therapeutic treatment and prophylactic or preventative measures, with the objective of preventing, reducing, slowing down (lessen), inhibiting, or eliminating an undesired physiological change, symptom, disease, or disorder. For example, the disease may be cervical dysplasia, cervical cancer,Covid- 19, EBV, HPV, HSV, etc. However, the present invention is not limited to said viral infections, and may be used to treat other viral conditions. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, alleviation of symptoms, diminishment of extent of disease, stabilized (i.e., not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable. "Treatment" can also mean prolonging survival as compared to expected survival if not receiving treatment. Those in need of treatment include those already with the condition or disorder as well as those prone to have the condition or disorder or those in which the condition or disorder is to be prevented or onset delayed. Optionally, the subject or patient may be identified (e.g., diagnosed) as one suffering from the disease or condition prior to administration of the compositions of the invention. Subjects at risk for the disease can be identified by, for example, any or a combination of appropriate diagnostic or prognostic assays known in the art.

[0049] The terms ‘'treating” or ‘'treatment” refer to any indicia of success or amelioration of the progression, severity7, and / or duration of a disease, pathology or condition, including any objective or subjective parameter such as abatement; remission; diminishing of symptoms or making the injury, pathology or condition more tolerable to the patient; slowing in the rate of degeneration or decline; making the final point of degeneration less debilitating; or improving a patient’s physical or mental well-being. "Treatment," as used herein, covers any administration or application of a therapeutic for disease in a mammal, including a human, and includes inhibiting the disease, arresting its development, or relieving the disease, for example, by causing regression, or restoring or repairing a lost, missing, or defective function; or stimulating an inefficient process.

[0050] Clinical Outcomes

[0051] As used herein, “clinical improvement” may refer to a noticeable reduction in the symptoms of a disorder, or cessation thereof.

[0052] The terms “manage,” “managing,” and “management” refer to preventing or slowing the progression, spread or worsening of a disease or disorder, or of one or more symptoms thereof. In certain cases, the beneficial effects that a subject derives from a prophylactic or therapeutic agent do not result in a cure of the disease or disorder.

[0053] The terms “regress,” “regressing,” and “regression” may refer to a decrease in the size of a tumor or in the extent of cancer in the body. In some embodiments, “regression” may refer to a decrease in severity of the disease and / or decrease in the size of a tumor. In some embodiments, regression may generally refer to lighter symptoms without the disease completely disappearing. In certain cases, the beneficial effects that a subject derives from a prophylactic or therapeutic agent do not result in a cure of the disease or disorder. In some embodiments, symptoms of the disease may return.

[0054] Administering

[0055] The terms ‘'administering” and “administration” refer to methods of providing a pharmaceutical preparation, composition, or formulation to a subject. The compositions described herein can be administered in a number of ways depending on whether local or systemic treatment is desired, and on the area to be treated. Such methods are well known to those skilled in the art and include, but are not limited to, administering the compositions orally, intranasally, parenterally (e g., intravenously and subcutaneously), by intramuscular injection, by intraperitoneal injection, intrathecally, transdermally, extracorporeally, topically or the like.

[0056] As used herein, the terms “administration” and “administering” refer to the act of giving a drug, prodrug, or other agent, or therapeutic treatment to a subject or in vivo, in vitro, or ex vivo cells, tissues, and organs. Exemplary routes of administration to the human body can be through space under the arachnoid membrane of the brain or spinal cord (intrathecal), the eyes (ophthalmic), mouth (oral), skin (topical or transdermal), nose (nasal), lungs (inhalant), oral mucosa (buccal), ear, rectal, vaginal, by injection (e.g., intravenously (IV), subcutaneously, intratumorally, intraperitoneally, etc.) and the like.

[0057] As used herein, the terms “co-administration” and “co-administering” refer to the administration of at least two agent(s) or therapies to a subject. In some embodiments, the co-administration of two or more agents or therapies is concurrent. In other embodiments, a first agent / therapy is administered prior to a second agent / therapy. Those of skill in the art understand that the formulations and / or routes of administration of the various agents or therapies used may vary. The appropriate dosage for co-administration can be readily determined by one skilled in the art. In some embodiments, when agents or therapies are co-administered, the respective agents or therapies are administered at lower dosages than appropriate for their administration alone. Thus, co-administration is especially desirable in embodiments where the co-administration of the agents or therapies lowers the requisite dosage of a potentially harmful(e.g.. toxic) agent(s). and / or when co-administration of two or more agents results in sensitization of a subject to beneficial effects of one of the agents via co-administration of the other agent.

[0058] Methods for Administering

[0059] Pharmaceutical compositions for oral administration include, but are not limited to, powders or granules, suspensions or solutions in water or non-aqueous media, pills, lozenges, capsules, sachets, or tablets. Thickeners, flavorings, diluents, emulsifiers, dispersing aids or binders may be desirable. A person of skill, monitoring a subject's clinical response, can adjust the frequency of administration and dosage according to methods known in the art.

[0060] For example, the compositions described herein can be administered by topical intranasal administration (intranasally) or administration by inhalant. As used herein, “topical intranasal administration” means delivery of the compositions into the nose and nasal passages through one or both of the nares and can comprise delivery by a spraying mechanism (device) or droplet mechanism (device), or through aerosolization of the composition. Administration of the compositions by inhalant can be through the nose or mouth via delivery' by a spraying or droplet mechanism. As used herein, “an inhaler” can be a spraying device or a droplet device for delivering a composition, in a pharmaceutically acceptable carrier, to the nasal passages and the upper and / or lower respiratory' tracts of a subject. Delivery can also be directly to any area of the respiratory system (e.g., lungs) via intratracheal intubation. The exact amount of the compositions required will vary from subject to subject, depending on the species, age, weight and general condition of the subject, the severity of the disorder being treated, the particular composition used, its mode of administration and the like. Thus, it is not possible to specify an exact amount for every composition. However, an appropriate amount can be determined by one of ordinary skill in the art using only routine experimentation given the teachings herein.

[0061] A composition can also be administered by buccal delivery or by sublingual deliver}'. As used herein “buccal deliver} ” may refer to a method of administration in which the compound is delivered through the mucosal membranes lining the cheeks. In some embodiment, for a buccal delivery the composition is placed between the gum and the cheek of a patient. As used herein “sublingual delivery” may refer to a method of administration in which the composition is delivered through the mucosal membrane under the tongue. In some embodiments, for a sublingual deliver}' the composition is administered under the tongue of a patient.

[0062] As used herein, the term "‘topical” means in the broadest sense through the skin. For topical administration, it will generally be desirable that the composition or active agents is applied topically to the skin in the form of formulations, in combination with an acceptable carrier, which may be a solid or a liquid. Topical formulations may include gels, creams, ointments, sprays, lotions, salves, sticks, soaps, powders, films, aerosols, drops, foams, pastes, solutions, emulsions, suspensions, dispersions e.g. non-ionic vesicle dispersions, milks and any other conventional pharmaceutical forms in the art. The use of solutions, suspensions, gels and emulsions are preferred, e.g. the active ingredient may be carried in water, a gas, a water-based liquid, an oil, a gel, an emulsion, an oil-in water or water-in-oil emulsions a dispersion or a mixture thereof. Topical formulations may be applied to body coverings or surfaces such as skin, bodily outgrowths such as hair and nails and surfaces such as mucosal membranes. Topical formulations may, for example, be used to confer therapeutic benefit to a patient or cosmetic benefits to a consumer. Topical formulations can be used for both topical and transdermal administration of substances. The term 'topical administration' is used in its conventional sense to mean delivery of a substance to the skin or a localized region of the body, advantageous for, for example, the treatment of various skin disorders. The term 'transdermal administration' is used to mean administration through the skin. Transdermal administration is often applied where systemic delivery of the composition is desired, although it may also be useful for delivering to tissues underlying the skin with minimal systemic absorption.

[0063] As used herein, the compositions described herein can be administered vaginally, such as intravaginal or transvaginal delivery, in the form of formulations. Vaginal administration may include vaginal inserts, for example, a tampon, tampon-like device, vaginal ring, vaginal cup, cervical cup, pessary, vaginal sponge, etc. The formulation may be incorporated into these vaginal inserts as a cream, lotion, foam, solution, paste, ointment, gel, capsules, powders or granules. Other forms include suppositories, vaginal tablets, and jelly preparations as vaginal inserts. In some embodiments, vaginal administration may comprise intravaginal and transvaginal preparation of ointment, cream, gel, fluid or powder, preferably incorporated into the intravaginal device. The intravaginal and transvaginal formulation may contact the vaginal wall where it treats the vaginal epithelium and mucosa, or it may be transported transvaginally into the uterus, cervix and even into the general circulation. The formulations may be combined with, for example, antipruritic agents, emollients and other soothing agents. In some embodiments, the intravaginal formulation may be formulated to adhere to and act directly on the vaginal epithelium and mucosa, or be transported or transferred through the vaginal wall. Fortransvaginal delivers- to the uterus and / or to the general circulation, additives may be added to promote transport and penetration of the formulation through the vaginal mucosa. Any excipient used in formulations of this invention needs to be approved for human use and acceptable for use in the vagina. A person of skill, monitoring a subject's clinical response, can adjust the frequency of administration and dosage of the medication according to methods known in the art.

[0064] As used herein, the formulations comprising the compositions described herein can be administered “rectally'’ which is by the lower enteral route, i.e., through the anus into the rectum or lower intestines. Rectal administration may include rectal suppositories, retention enemas, rectal catheters, rectal inserts that act as carriers of the formulation in the form of a cream, lotion, foam, solution, paste, ointment, gel, capsules, powders or granules. Other forms include anal preparation of ointment, cream, gel, or fluid. The formulations may be combined with, for example, antipruritic agents, emollients and other soothing agents. Any excipient used in formulations of this invention needs to be approved for human use and acceptable for use in the anus. A person of skill, monitoring a subject's clinical response, can adjust the frequency of administration and dosage of the medication according to methods known in the art.

[0065] Parenteral administration of the composition, if used, is generally characterized by injection. Injectables can be prepared in conventional forms, either as liquid solutions or suspensions, solid forms suitable for solution of suspension in liquid prior to injection, or as emulsions. A more recently revised approach for parenteral administration involves use of a slow release or sustained release system such that a constant dosage is maintained.

[0066] In another aspect, the compositions described herein can be administered to a subject intramuscularly, e g., by using muscular injections or electroporation. A person of skill, monitoring a subject's clinical response, can adjust the frequency of administration and dosage of the medication according to methods known in the art.

[0067] In some embodiments, the compositions of the invention can be placed or stored in a container, bottle, bag, pack, or dispenser together with instructions for administration. For example, the instructions can include directions for administering the composition to the subject.

[0068] Pharmaceutical Formulations

[0069] As described above, the compositions can be administered to a subject in a pharmaceutically acceptable carrier. By “pharmaceutically acceptable” is meant a material that isnot biologically or otherwise undesirable, i.e.. the material may be administered to a subject without causing any undesirable biological effects or interacting in a deleterious manner with any of the other components of the pharmaceutical composition in which it is contained. The carrier would naturally be selected to minimize any degradation of active ingredients and to minimize any adverse side effects in the subject, as would be well known to one of skill in the art.

[0070] A "pharmaceutically acceptable carrier" refers to a non-toxic solid, semisolid, or liquid filler, diluent, encapsulating material, formulation auxiliary', or carrier conventional in the art for use with a therapeutic agent for administration to a subject. A pharmaceutically acceptable carrier is non-toxic to recipients at the dosages and concentrations employed and is compatible with other ingredients of the formulation. The pharmaceutically acceptable carrier is appropriate for the formulation employed. For example, if the therapeutic agent is to be administered orally, the carrier may be a gel capsule. If the therapeutic agent is to be administered subcutaneously, the carrier ideally is not irritable to the skin and does not cause injection site reaction.

[0071] Pharmaceutical carriers are known to those skilled in the art. These most ty pically w ould be standard carriers for administration of drugs to humans, including solutions such as sterile water, saline, and buffered solutions at physiological pH. Typically, an appropriate amount of a pharmaceutically-acceptable salt is used in the formulation to render the formulation isotonic. Examples of the pharmaceutically-acceptable carrier include, but are not limited to, saline, Ringer's solution, and dextrose solution. The pH of the solution is preferably from about 5 to about 8, and more preferably from about 7 to about 7.5. Further carriers include sustained release preparations such as semi-permeable matrices of solid hydrophobic polymers containing the disclosed compounds, which matrices are in the form of shaped articles, e.g., films, liposomes, microparticles, or microcapsules. It will be apparent to those persons skilled in the art that certain carriers can be more preferable depending upon, for instance, the route of administration and concentration of composition being administered. Other compounds can be administered according to standard procedures used by those skilled in the art.

[0072] Pharmaceutical compositions can include additional carriers, as well as thickeners, diluents, buffers, preservatives, surface active agents, and the like in addition to the compounds disclosed herein. Pharmaceutical compositions can also include one or more additional active ingredients such as antimicrobial agents, anti-inflammatory agents, anesthetics, and the like. Other suitable pharmaceutically acceptable carriers include solvents, dispersion media, coatings,isotonic and absorption delaying agents, and the like, which are compatible with pharmaceutical administration. Supplementary active compounds can also be incorporated into the compositions.

[0073] Pharmaceutical formulations can include additional carriers, as well as thickeners, diluents, buffers, preservatives, surface active agents and the like in addition to the compounds disclosed herein. Pharmaceutical formulations can also include one or more additional active ingredients such as antimicrobial agents, anti-inflammatory agents, anesthetics, and the like.

[0074] Any of the minerals disclosed herein may be used in the form of pharmaceutically acceptable salts. As used herein, “pharmaceutically acceptable’’ is meant that which is useful for the preparation of a pharmaceutical composition and is generally safe, non-toxic and neither biologically nor otherwise undesirable and which is acceptable for veterinary use as well as in human pharmaceutics.

[0075] By “pharmaceutically acceptable salts” of a compound is meant salts which are pharmaceutically acceptable as defined herein and which have the desired pharmacological action of the parent compound. Such salts comprise useful salts are acid addition salts, which are formed by pharmaceutically acceptable free acids. The acid addition salts are obtained from inorganic acid, such as hydrochloric acid, nitric acid, phosphoric acid, sulfuric acid, hydrobromic acid, hydroiodic acid, nitrous acid or phosphorous acid and the like; or formed with pharmaceutically acceptable organic acids, such as aliphatic mono- and dicarboxylates, phenyl-substituted alkanoates, hydroxyalkanoates, alkanedioates, aromatic acids, aliphatic and aromatic sulphonic acids, acetic acid, benzenesulfonic acid, benzoic acid, camphorsulfonic acid, citric acid, ethane-sulfonic acid, fumaric acid, glucoheptonic acid, gluconic acid, glutamic acid, glycolic acid, hydroxynaphthoic acid, 2-hydroxyethanesulfonic acid, lactic acid, maleic acid, malic acid, mandelic acid, methanesulfonic acid, muconic acid, 2-naphthalenesulfonic acid, propionic acid, salicylic acid, succinic acid, dibenzoyl-L-tartaric acid, tartaric acid, p-toluenesulfonic acid, trimethylacetic acid, trifluoroacetic acid and the like. Such pharmaceutically nontoxic salts include sulfate, pyrosulfate, bisulfate, sulfite, bisulfite, nitrate, phosphate, monohydrogen phosphate, dihydrogen phosphate, metaphosphate, pyrophosphate chloride, bromide, iodide, fluoride, acetate, propionate, decanoate, caprylate, acrylate, formate, isobutyrate, caprate, heptanoate, propiolate, oxalate, malonate, succinate, suberate, sebacate, fumarate, maleate, butyne- 1,4-dioate, hexane- 1,6-dioate, benzoate, chlorobenzoate, methylbenzoate, dinitro benzoate, hydroxybenzoate, methoxy benzoate, phthalate, terephthalate, benzene sulfonate, toluene sulfonate, chlorobenzene sulfonate, xylenesulfonate, phenyl acetate,phenylpropionate, phenylbutyrate, citrate, lactate, hydroxybutyrate, glycolate, malate, tartrate, methane sulfonate, propane sulfonate, naphthalene-1 -sulfonate, naphthalene-2-sulfonate or mandelate.

[0076] In other embodiments, the pharmaceutically acceptable salts may comprise the addition salts of pharmaceutically acceptable bases formed when an acid proton contained in the parent compound is either replaced by a metal ion e.g. an alkaline metal ion, an alkaline-earth metal ion or aluminum ion; or coordinated with a pharmaceutically acceptable organic or inorganic base. Acceptable organic bases include diethanolamine, ethanolamine, N-methylglucamine, triethanolamine, tromethamine and the like. Acceptable inorganic bases include aluminum hydroxide, calcium hydroxide, potassium hydroxide, sodium carbonate and sodium hydroxide.

[0077] In some embodiments, the compositions described herein may include bases that can encourage timed release. Non-limiting examples of such bases include hydrogels, micelles, vesicles, nanoparticles, hydroxypropyl methylcellulose (HPMC), poly(ethylene glycol) (PEG), polylactides (PLA), polyglycolides (PGA), poly(lactide-co-glycolides) (PLGA), polyanhydrides, and polyorthoesters.

[0078] The pharmaceutical formulation can be administered in a number of ways depending on whether local or systemic treatment is desired, and on the area to be treated. A preferred mode of administration of the composition is parenterally, for example by intravenous drip, subcutaneous, intraperitoneal, or intramuscular injection. Other modes of administration may be topically (including vaginally, rectally, intranasally), by inhalation or orally, intravenously, intraperitoneally, intramuscularly, subcutaneously, intracavity, transdermally, sublingually or through buccal deliver}'.

[0079] Formulations for parenteral administration include sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents are propylene glycol, polyethylene glycol, vegetable oils such as olive oil, fish oils, and injectable organic-esters such as ethyl oleate. Aqueous carriers include water, alcoholic / aqueous solutions, emulsions or suspensions, including saline and buffered media. Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils. Intravenous vehicles include fluid and nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. Preservatives and other additives may also be present such as, for example, antimicrobials, antioxidants, chelating agents, inert gasses, and thelike. Another approach for parenteral administration involves use of a slow release or sustained release system such that a constant dosage is maintained.

[0080] The pharmaceutical formulation can be administered in a number of ways depending on whether local or systemic treatment is desired, and on the area to be treated. A preferred mode of administration of the composition is topically (including ophthalmically, vaginally, rectally, intranasally) or by injection. Other modes of administration may be orally, or parenterally, for example by intravenous drip, subcutaneous, intraperitoneal or intramuscular injection. The disclosed compounds can be administered by inhalation, sublingually, intravenously, intraperitoneally, intramuscularly, subcutaneously, intracavity, transdermally, through buccal delivery, or by pulmonary lavage.

[0081] Pharmaceutical formulations for topical or transdermal administration may include ointments, lotions, creams, gels, drops, adherent patches, iontophoresis, suppositories, sprays, liquids, and powders. Conventional pharmaceutical carriers, aqueous, powder or oily bases, thickeners, and the like may be necessary' or desirable. A person of skill, monitoring a subject's clinical response, can adjust the frequency of administration and dosage of the medication according to methods known in the art.

[0082] Therapeutically Effect Amount

[0083] A “therapeutically effective amount'’ refers to an amount that is sufficient to achieve the desired therapeutic result or to have an effect on undesired symptoms, but is generally insufficient to cause adverse side effects. The specific therapeutically effective dose level for any particular patient will depend upon a variety of factors including the disorder being treated and the severity of the disorder; the specific composition employed; the age, body weight, general health, sex and diet of the patient; the time of administration; the route of administration; the rate of excretion of the specific compound employed; the duration of the treatment; drugs used in combination or coincidental with the specific compound employed and like factors well known in the medical arts. For example, it is w ell w ithin the skill of the art to start doses of a compound at levels lower than those required to achieve the desired therapeutic effect and to gradually increase the dosage until the desired effect is achieved. If desired, the effective daily dose can be divided into multiple doses for purposes of administration. Consequently, single dose compositions can contain such amounts or submultiples thereof to make up the daily dose. The dosage can be adjusted by the individual physician in the event of any contraindications. Dosage can vary, and can be administered in one or more dose administrations daily, for one or severaldays, weekly, twice weekly, etc. Guidance can be found in the literature for appropriate dosages for given classes of pharmaceutical products.

[0084] The exact amount of the compositions required will vary from subject to subject, depending on the species, age, weight, and general condition of the subject, the severity of the disorder being treated, the particular composition used, its mode of administration and the like. Thus, it is not possible to specify an exact amount for every composition. However, an appropriate amount can be determined by one of ordinary skill in the art using only routine experimentation given the teachings herein.

[0085] The term “effective amount” as used herein refers to the amount of a therapy which is sufficient to reduce and / or ameliorate the severity and / or duration of a given disease, disorder or condition and / or a symptom related thereto. This term also encompasses an amount necessary for the reduction or amelioration of the advancement or progression of a given disease, disorder or condition, reduction or amelioration of the recurrence, development or onset of a given disease, disorder or condition, and / or to improve or enhance the prophylactic or therapeutic effect(s) of another therapy. In some embodiments, “effective amount” as used herein also refers to the amount of therapy provided herein to achieve a specified result.

[0086] As used herein, and unless otherwise specified, the term “therapeutically effective amount” of a composition described herein is an amount sufficient to provide a therapeutic benefit in the treatment or management of a cancer, or to delay or minimize one or more symptoms associated with the presence of the cancer. A therapeutically effective amount of a composition described herein means an amount of therapeutic agent, alone or in combination with other therapies, which provides a therapeutic benefit in the treatment or management of the cancer. The term “therapeutically effective amount” can encompass an amount that improves overall therapy, reduces or avoids symptoms or causes of cancer, or enhances the therapeutic efficacy of another therapeutic agent.

[0087] Dosage

[0088] In some embodiments, the dosage can be administered to a subject once daily or in divided dosages throughout a day, depending on a subject's clinical response to the medication, as determined by methods known in the art. This dosage can be administered to a subject for one day, one a week, or a number of days, and then stopped if the subject responds immediately, or the dosage can be administered on a daily basis until a clinical response is noted. A person ofskill can monitor a subject's clinical response to the administration of the composition and administer additional dosages as needed. It is contemplated that the compositions described herein can be administered to a subject on a daily basis, on an alternating daily basis, on a weekly basis, or at any interval in between.

[0089] It is advantageous to formulate the compositions in dosage units for ease of administration and uniformity of dosage. Dosage units refer to physically discrete units suited as unitary dosages for the subject to be treated, each unit containing a predetermined quantity of the composition calculated to produce the desired therapeutic effect in association with the required pharmaceutical carrier.

[0090] The dosage may vary within this range depending upon the dosage form employed and the route of administration utilized. For any compositions used, the therapeutically effective dose can be estimated initially from cell culture assays in which, e.g., the rate of cell death is observed. A dose may be formulated in animal models to achieve a concentration range that includes the IC50(i.e. , the concentration of the test compound which achieves a half-maximal inhibition of symptoms) as determined in cell culture. Such information may be used to more accurately determine useful doses in humans.

[0091] Administration Timing

[0092] In one aspect, the composition can be administered in an intravenous dosage. This dosage can be administered to a subject once daily or in divided dosages throughout a day. as determined by methods known in the art. This dosage can be administered to a subject on a daily basis until a clinical response is noted. It is contemplated that the dosage of the composition can be administered as infrequently as once daily or weekly, or at any interval in between, depending on a subject's clinical response to the medication. If a subject does not respond to the initial dosage and administration of the composition, a person of skill can administer the medication daily for several days until such response occurs. A person of skill can monitor a subject's clinical response to the administration of the composition and administer additional dosages. It is contemplated that composition can be administered to a subject with, for example, COVID- 19 on a twice daily basis, once daily basis, on an alternating daily basis, on a weekly basis, on a monthly basis, or at any interval in between.

[0093] In another aspect, the composition can be administered to a subject intranasally in a dosage taken once daily or in divided doses. The medication can be administered daily or weekly,or at any interval in between. A person of skill, monitoring a subject's clinical response to the administration of the medication, can adjust the frequency of administration according to methods known in the art.

[0094] In some embodiments, the composition for use may be administered once daily or twice daily. In another embodiment, the composition may be administered at least once to four times daily. In some embodiments, the composition may be administered at least once daily, at least once every other day, or at least once weekly. In other embodiments, the composition is administered at a daily dose ranging from about 1g to 150g. Further still, the composition may be administered intravenously, or by inhalation. In preferred embodiments, the composition for use in the treatment resulted in clinical improvement of a disease.

[0095] In another embodiment, the composition is administered in a dosage of about Img / kg of body weight to 200mg / kg of body weight. For example, the dosage may range from about 0. 1g to 20g, with a preferred range of about 5g to 10g for administration intravenously and a preferred range of 0.5 g to 6g for administration by inhalation. The composition may be administered once daily or twice daily; or the composition may be administered once to four times daily; or the composition may be administered at least once daily, at least once every other day. or at least once weekly.

[0096] Integration of viruses like HPV. such as that which is cited by the 2007 IRAC Working Group on the Evaluation of Carcinogenic Risks to Humans Monograph, is known to disrupt viral replicative cycles. Integration allows a virus to evade identification (such as that which would be provided by PCR) until such a time that the environment is ideal for replication — an occurrence that is dependent on disulfide bond donation and exchange.

[0097] Up-regulation of disulfide bond-building donation and exchange encourages a virus to dissociate from integration loci. A dissociated virus then begins to actively replicate with availability of disulfide bonds. An actively replicating virus provides an opportunity for drug medicament degradation, such as that of intron splicing. RNA degradation, DNA / RNA inhibition, or protease inhibition — whether that be orally, topically, intravenously, intramuscularly, or subcutaneously administered.

[0098] During the process of disulfide bond donation and exchange, viral load would increase.This is because viruses, such as HPV. utilize di sulfide bonds for building of their capsi d proteins,remaining quiescent at host DNA loci until they are actively replicating, a process that requires disulfide bonds. When a virus is liberated from its integrated loci and actively replicating due to the presence of disulfide bond availability, the host cell may become damaged. The damage may ensue either by virtue of the rise in RNAi cofactors and immune activity upon the recognition of foreign nucleic acids, as can signal deleterious inflammatory reactions, or due to the virus itself.

[0099] Regardless of mechanism, the moment of viral active replication due to the presence of the disulfide bond is the moment cytoprotection may provide merit in adding to the drug therapy. In addition, some known cytoprotective compounds have viral inhibitory actions as well, which could enhance the overall antiviral response and treatment. To whit, in some embodiments, administration of exogenous medicaments or compounds with known cytoprotective effects may serve to avert or prevent deleterious cell development during active infection or abnormal pathophysiologic acti vity.

[0100] It is an objective of the present invention to provide compositions for treating a viral condition. In some embodiments, the composition for treating a viral condition may comprise a first medicament effective for up-regulating disulfide bond donation and exchange, and a second medicament comprising a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, an intron splicer, or combinations thereof. In some embodiments, the viral condition is cervical dysplasia, cervical cancer, Covid- 19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection. However, the present invention is not limited to said viral infections, and may be used to treat other viral conditions. Without wishing to limit the present invention, the first medicament is effective for causing viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds. In some embodiments, the second medicament is effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.

[0101] In conjunction with the embodiments described herein, the amount of the first medicament can range from about 5% to about 99% w / v of the composition. In other embodiments, the amount of the second medicament can range from about 0.01% to about 50% w / v of the composition.

[0102] In other embodiments, the composition for treating a viral condition may comprise one or more omega-3 fatty acids, and an herbal preparation of Sarracenia fiava. Sarracenia purpurea, Sarracenia alata. or mixed hybrids thereof. In some embodiments, the omega-3 fattyacids are a-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Without wishing to limit the present invention, this composition has cytoprotective and antiviral effects. In some embodiments, the viral condition is human papillomavirus. In some embodiments, the composition is formulated for oral administration, topical administration, or intramuscular, subcutaneous or intravenous injections. In other embodiments, the composition is in a form of a lotion, cream, oil, balm, gel, injectable solution, or oral tincture. In some embodiments, the composition may be used in a method of treating a viral condition in a subject in need thereof. The method may comprise administering to the subject a therapeutic dose of the composition.

[0103] According to other embodiments, the composition for treating a viral condition may comprise about 5% to about 99% w / v of a first medicament that contains disulfide bonds, and about 0.01% to about 50% w / v of a second medicament effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA. viral DNA. and / or viral proteins.

[0104] According to some other embodiments, the composition for treating a viral condition may comprise about 5% to about 99% w / w of a first medicament that contains disulfide bonds, and about 0.01% to about 50% w / v of a second medicament effective for enhancing the disulfide bond effect that causes dissociation and replication of viruses. The first medicament may comprise an active agent that comprises said disulfide bonds. In a non-limiting embodiment, the first medicament is an herbal preparation of Sarracenia flava that contains disulfide bonds. In a non-limiting embodiment, the second medicament is magnesium. Magnesium can enhance the disulfide bond effect that causes the virus to dissociate and replicate.

[0105] In other embodiments, the composition for treating a viral condition may comprise an herbal preparation of Sarracenia flava, Sarracenia purpurea, Sarracenia alata. or mixed hybrids thereof, and one or more omega-3 fatty acids. The herbal preparation contains disulfide bonds. The composition can have cytoprotective and antiviral effects. In some embodiments, the omega-3 fatty7acids are a-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). In a non-limiting embodiment, the composition for treating a viral condition may comprise an herbal preparation of Sarracenia purpurea and docosahexaenoic acid (DHA). In non-limiting embodiments, the amount of the herbal preparation can range from about 5% to about 99% w / v of the composition. In other embodiments, the amount of omega-3 fatty acids can range from about 0.01% to about 50% w / v of the composition.

[0106] According to other embodiments, the present invention features a method of treating a viral condition in a subject in need thereof. The method may comprise administering to the subject a therapeutic amount of any of the compositions described herein. In some embodiments, the composition may be administered orally, topically, intravenously, intramuscularly, or subcutaneously. The viral condition is cervical dysplasia, cervical cancer, Covid- 19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection. However, the present invention is not limited to said viral infections, and may be used to treat other viral conditions. In some embodiments, the composition is in a form of a lotion, cream, oil, balm, gel, injectable solution, or oral tincture.

[0107] In other embodiments, the method of treating a viral condition in a subject in need thereof may comprise administering to the subject a therapeutic dose of a first medicament effective for up-regulating disulfide bond donation and exchange, and administering to the subject a therapeutic dose of a second medicament comprising one or more of the following: a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, or an intron splicer. The viral condition may be cervical dysplasia, cervical cancer, Epstein Barr virus, human papillomavirus, or herpes simplex virus. In some embodiments, the first medicament may cause viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds. In other embodiments, the second medicament supports or improves degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.

[0108] In conjunction with the compositions and methods described herein, the first medicament may comprise glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, keratins, or a combination thereof.

[0109] In other embodiments, the DNA / RNA inhibitor is Actinomycin D, Remdesivir, Mithramycin A, Azidothymidine, Aphidicolin, Acyclovir, Entecavir, Favipiravir, Gahdesivir, Rilpivirine, Risdiplam, Tenofovir, or a combination thereof.

[0110] In some other embodiments, the DNA polymerase is Abacavir, Adefovir, Cidofovir, Entecavir, Famciclovir, Foscamet, Emticitabine, Entecavir, Lamivudine, Stavudine, Telbivudine, Tenofovir, or a combination thereof.[001 II ] In some embodiments, the protease inhibitor is Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir, Ritonavir, or a combination thereof.In other embodiments, the intron splicer is maturase enzymes.

[0112] In some embodiments, the second medicament may comprise an E6 inhibitor. The E6 inhibitor may be lucidin, racidin, or taxifolin The E6 inhibitor may be used to treat HPV infections and / or cervical cancer.

[0113] In a non-limiting embodiment, the second medicament may comprise iron bisglycinate, ascorbic acid, DHS, magnesium, pyruvate, a methyltransferase inhibitor, or a combination thereof. In some embodiments, the methyltransferase inhibitor is celery root.

[0114] In some embodiments, the first medicament may be administered orally, topically, intravenously, intramuscularly, or subcutaneously. In other embodiments, the second medicament may be administered orally, topically, intravenously, intramuscularly, or subcutaneously. In some other embodiments, the first medicament and the second medicament are administered at the same time or at different times.

[0115] According to some embodiments, the present invention features a method for detecting and / or identifying a virus in a subject. The method may comprise administering to the subject a composition that up-regulates disulfide bond donation and exchange so as to increase availability of disulfide bonds in the subject, which causes viruses to dissociate from integration sites and actively replicate with the availability of disulfide bonds. In some embodiments, the composition may comprise glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, keratins, or a combination thereof. In some embodiments, the virus is Coronavirus, Epstein Barr virus, human papillomavirus, or herpes simplex virus. However, the present invention is not limited to said viruses, and may be used to identify other viruses.

[0116] According to other embodiments, the present invention features a kit for treating a viral condition. In some embodiments, the kit may comprise a first medicament effective for up-regulating disulfide bond donation and exchange; a second medicament comprising one or more of the following: a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, or an intron splicer; and instructions for administering the first and second medicaments to a subject in need of such treatment. In some embodiments, the viral condition is cervical dysplasia, cervical cancer, Covid-19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection. However, the present invention is not limited to said viralinfections, and may be used to treat other viral conditions.

[0117] Without wishing to limit the present invention to a particular theory or mechanism, the first medicament may be effective for causing viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds. The second medicament is effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.

[0118] In some embodiments, the first medicament comprises glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, keratins, or a combination thereof. In other embodiments, the DNA / RNA inhibitor is Actinomycin D, Remdesivir, Mithramycin A, Azidothymidine, Aphidicolin, Acyclovir, Entecavir, Favipiravir, Galidesivir, Rilpivirine. Risdiplam, Tenofovir, or a combination thereof. In some other embodiments, the DNA polymerase is Abacavir, Adefovir, Cidofovir, Entecavir, Famciclovir, Foscamet, Emticitabine, Entecavir, Lamivudine, Stavudine, Telbivudine, Tenofovir, or a combination thereof.

[0119] In some embodiments, the protease inhibitor is Amprenavir, Atazanavir, Darunavir, Fosamprenavir , Indinavir, Lopinavir, Nelfinavir, Ritonavir, or a combination thereof. In other embodiments, the intron splicer is maturase enzymes. In some embodiments, the second medicament comprises iron bisglycinate, ascorbic acid, DHS. pyruvate, a methyltransferase inhibitor, or a combination thereof. In some embodiments, the methyltransferase inhibitor is celery root. In other embodiments, the viral condition is cervical dysplasia, cervical cancer, Epstein Barr virus, human papillomavirus, or herpes simplex virus.

[0120] In some embodiments, the instructions comprises one or more steps for administering each of the first medicament and the second medicament orally, topically, intravenously, intramuscularly, or subcutaneously. In other embodiments, the instructions comprises one or more steps for administering the first medicament and the second medicament at the same time or at different times. In some embodiments, the first medicament and the second medicament are combined to form a composition. In other embodiments, the instructions comprises one or more steps for administering the composition orally, topically, intravenously, intramuscularly, or subcutaneously.

[0121] Nature provides many examples of agents that are known to both exhibitcytoprotective and antiviral qualities and effects. Carnivorous plants may provide examples of this. For example, previous experiments wi th Sarracenia purpurea demonstrated cytoprotection in glucotoxic PC 12 cell lines due to quercetin-3-Ogalactose and morroniside content. Another example of cytoprotective qualities is that of DHA, an omega oil commonly found within algae species. Interestingly, it was found that omega oils such as DHA activate the ubiquitm-proteasome system which has direct antiviral activities, in particular against HPV. Combining extracts of S. purpurea and DHA may provide additive cytoprotective effects.

[0122] Host cells may be limited in their ability to degrade viruses due to gene polymorphisms. A specific example related to a host gene change that may inhibit host ability to degrade viral load is HFE-C282Y. HFE-C282Y is related to hemochromatosis. The standard treatments for hemochromatosis are twofold: elimination / removal of iron from the patient’s diet and phlebotomy. However, contrary to standard treatments, it has been discovered by the inventor that it is necessary to provide iron for patients with HFE-C282Y, not to eliminate it. Without wishing to limit the present invention to a particular theory or mechanism, adding a trans-cellular form of iron, such as that of iron bisglycinate, bypasses the inability to absorb iron, possibly due to challenges presented by TFR2-rs7385804. Furthermore, providing cofactors for iron usage by the cell (such as ascorbic acid and DHA) supports the iron cycle directly.

[0123] Host cellular support may be necessary to address gene polymorphisms that may inhibit or prevent the action of the drug medicaments. This support could be added either as a stand-alone medicament within a final drug product or built into a drug molecule. Examples of gene polymorphisms that may need to be addressed include: HFE-C282Y / TFR2-rs738 5804, GADlrs3749034 / GADl-rs2241165 / GADl-rs3791850 / GADl-rs3791851 / SLC1747-rs74174284, TCF7L2-rs7903146 / PPARGClA-rs8192678, and MTHFR- 1298-rsl801131 / MTRR A66G-rs 1801394 / MTR A2756G-rs 1805087.

[0124] Mitochondrial support may also be necessary for the host cell in any medicament designed for viral degradation. Providing pyruvate (also identified by the inventor as beneficial for patients struggling to resolve viral-mediated diseases and symptom expressions) supports mitochondrial production of ATP but may also inhibit elevated glutamine / glutamate. Glutamine / glutamate, elevated in the event of GADl-rs3749034 / GADl-rs2241165 / GADl-rs3791850 / GADl-rs3791851 / SLC1747-rs74174284, potentiates viruses such as HPV.

[0125] In some embodiments, drug medicaments included in disulfide bond building must avoid the addition of methyl groups to the final formulation. Without wishing to limit the present invention to a particular theory' or mechanism, the inventor had noticed MTHFR gene changes with respect to patients trending towards chronic viral-mediated conditions, such as chronic cervical dysplasia due to HPV and active HSV mucosal membrane lesions. When patients with said MTHFR polymorphisms (MTHFR-1298-rsl 801131 / MTRR A66G-rsl801394 / MTR A2756G-rs 1805087) avoided oral use of methylated folate, folic acid or any form of folic acid supplementation, the disulfide bond-building herbal / drug medicaments compounded formulations provided more efficient results.

[0126] Iron bisglycinate is necessary' to support HFE-C282Y (as opposed to overtly reducing iron levels). A trans-membrane iron (to override changes due to TFR2-rs7385804) supports cellular iron levels, reducing oxidative stress to the mitochondria. Patients with HFE / TFR2 gene changes have a reduced ability to transport iron across cell membranes into the cell, which may be why their extracellular iron levels rise. Ascorbic acid and DHA are appropriate to pair with iron bisglycinate for totality' of support of the iron cycle.

[0127] Calcium pyruvate inhibits glutamine / glutamate and up-regulates mitochondrial biogenesis, overriding gene polymorphisms at GADlrs3749034 / GADl-rs2241165 / GADl-rs3791850 / GADl-rs3791851 / SLC1747-rs74174284 and TCF7L2-rs7903146 / PPARGClA-rs8192678.

[0128] Decreases in hypermethylation by methylation-inhibiting medicaments such as celery root extract or methyltransferase inhibitors are important to reduce viral use of methyl groups, especially by HPV. This would be important for patients with MTHFR- 1298-rsl801131 / MTRR A66G-rsl801394 / MTR A2756G-rsl805087.

[0129] EXAMPLES

[0130] The following are non-limiting examples of the present invention. It is to be understood that said examples are not intended to limit the present invention in any way. Equivalents or substitutes are within the scope of the present invention.

[0131] EXAMPLE 1 : Table 1 provides an example of a female subject’s negative HPV history (Pap and urine). Treatment began in 2016 with intermittent use of a disulfide bond-containing herbal medicament (keratin / magnesium sulfate bath soak formulation). Thefemale subject noticed symptoms such as increased urinary urgency with polyuria. In 2018, increased sensations of urinary urgency with polyuria prompted urine testing for viral and bacterial presence. Urine was positive initially for BV (specifically Gardnerella vaginosis), and later for HPV. Testing continued as symptoms shifted to include vaginal clots, fatigue, and menorrhagia. Table 1 demonstrates symptoms over time paralleled to urine results which demonstrated HPV (varying strains over the course of a year). There was no viral or bacterial exposure during the course of study. This study additionally provides an example of an unusual result of bacterial resolution (specifically from BV) with a disulfide-bond containing medicament.

[0132] Table 1

[0133] EXAMPLE 2: A patient with oral mucosal HSV vesicular lesions that were very painful, who had been on oral dosing of disulfide bond-building herbal compounded with Ritonavir / Valcycylovir. experienced favorable reduction in HSV-related vesicular lesion when his methylated B vitamin supplements were removed from his supplement regimen. This is contrary to standard treatment for MTHFR polymorphisms, which states that methylated forms of B vitamins, in particular, folic acid or folate, is necessary.

[0134] EXAMPLE 3: Table 2 demonstrates gene changes in patients with persistent viral conditions (such as HPV-related cervical dysplasia), as noted by the patients' doctor. These gene changes pertain to iron cycle regulation (HFE-C282Y / TFR2-rs7385804), glutamine (GAD1), mitochondrial functionality (TCF7L2-rs7903146 / PPARGCl A-rs8192678), and methylation (MTHFR 677-rsl801133 / MTR A2756G-rsl805087 / MTRR A66G-rs 1801394).

[0135] Table 2

[0136] EXAMPLE 4: Table 3 provides examples of additional medicaments or derivatives that may be provided to support gene polymorphisms.

[0137] Table 3

[0138] EXAMPLE 5: Table 4 provides examples of drug medicaments which may be utilized for pairing to a disulfide bond-containing (thiols groups via glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin, protein disulfide isomerases, or keratins) medicaments.

[0139] Table

[0140] As used herein, the term ‘’about” refers to plus or minus 10% of the referenced number.

[0141] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of’ or “consisting of; and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of’ or “consisting of’ is met.

Claims

WHAT IS CLAIMED IS:1) A composition for treating a viral condition, comprising a first medicament effective for up-regulating disulfide bond donation and exchange, and a second medicament comprising one or more of the following: a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, or an intron splicer, wherein the first medicament is effective for causing viruses to dissociate from integration sites and actively replicate with availability of disulfide bonds, and wherein the second medicament is effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.2) The composition of claim 1, wherein the first medicament comprises glutathione, glutathione disulfide, cysteine, cystine, thioredoxin. glutaredoxin, protein disulfide isomerases, keratins, or a combination thereof.3) The composition of claim 1, wherein the DNA / RNA inhibitor is Actinomycin D, Remdesivir, Mithramycin A, Azidothymidine, Aphidicolin, Acyclovir, Entecavir, Favipiravir, Galidesivir, Rilpivirine, Risdiplam, Tenofovir, or a combination thereof.4) The composition of claim 1, wherein the DNA polymerase is Abacavir, Adefovir, Cidofovir, Entecavir, Famciclovir. Foscamet, Emticitabine. Entecavir, Lamivudine, Stavudine, Telbivudine, Tenofovir. or a combination thereof.5) The composition of claim 1, wherein the protease inhibitor is Amprenavir, Atazanavir, Darunavir, Fosamprenavir , Indinavir. Lopinavir, Nelfmavir, Ritonavir, or a combination thereof.6) The composition of claim 1, wherein the intron splicer is maturase enzy mes.7) The composition of claim 1. wherein the second medicament comprises iron bisglycinate, ascorbic acid, DHS, pyruvate, magnesium, a methyltransferase inhibitor, or a combination thereof.8) A method of treating a viral condition in a subject in need thereof, the method comprises: a) administering to the subject a therapeutic dose of a first medicament effective for up-regulating disulfide bond donation and exchange; and b) administering to the subject a therapeutic dose of a second medicamentcomprising one or more of the following: a DNA polymerase inhibitor, a protease inhibitor, a DNA / RNA inhibitor, or an intron splicer; wherein the first medicament causes viruses to dissociate from integration sites and actively replicate with availability' of disulfide bonds, and wherein the second medicament supports or improves degradation, slicing, and / or inhibition of viral RNA, viral DNA, and / or viral proteins.9) The method of claim 8, wherein the first medicament comprises glutathione, glutathione disulfide, cysteine, cystine, thioredoxin, glutaredoxin. protein disulfide isomerases, keratins, or a combination thereof.10) The method of claim 8, wherein the DNA / RNA inhibitor is Actinomycin D, Remdesivir, Mithramycin A, Azidothymidine. Aphi dicolin, Acyclovir, Entecavir, Favipiravir, Galidesivir, Rilpivirine, Risdiplam, Tenofovir, or a combination thereof.11) The method of claim 8, wherein the DNA polymerase is Abacavir, Adefovir, Cidofovir, Entecavir, Famciclovir, Foscamet, Emticitabine, Entecavir, Lamivudine, Stavudine, Telbivudine, Tenofovir, or a combination thereof.12) The method of claim 8, wherein the protease inhibitor is Amprenavir, Atazanavir, Darunavir, Fosamprenavir , Indinavir. Lopinavir, Nelfmavir, Ritonavir, or a combination thereof.13) The method of claim 8, wherein the intron splicer is maturase enzy mes.14) The method of claim 8, wherein the second medicament comprises iron bisglycinate, ascorbic acid, DHS, pyruvate, a methyltransferase inhibitor, or a combination thereof.15) The method of claim 8, wherein the viral condition is cervical dysplasia, cervical cancer, Covid- 19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection.16) The method of claim 8. wherein the first medicament and the second medicament are administered at the same time or at different times.17) The method of claim 8, wherein the first medicament is administered orally, topically, intravenously, intramuscularly, subcutaneously vaginally. rectally, sublingually,intranasally, or by injection.18) The method of claim 8, wherein the second medicament is administered orally, topically, intravenously, intramuscularly, subcutaneously vaginally. rectally, sublingually, intranasally, or by injection.19) A composition for treating a viral condition, comprising a first medicament that contains disulfide bonds, and a second medicament effective for supporting or improving degradation, slicing, and / or inhibition of viral RNA. viral DNA. and / or viral proteins.20) The composition of claim 19, wherein the first medicament comprises an active agent that comprises said disulfide bonds.21) The composition of claim 19, wherein the second medicament comprises magnesium.22) A composition for treating a viral condition, comprising an herbal preparation of Sarracenia flava that contains disulfide bonds, and magnesium.23) A composition for treating a viral condition, comprising an herbal preparation of Sarracenia flava, Sarracenia purpurea, Sarracenia alata, or mixed hybrids thereof, and one or more omega-3 fatty acids, wherein said herbal preparation contains disulfide bonds, wherein the composition has cytoprotective and antiviral effects.24) The composition of claim 23, wherein the omega-3 fatty acids are a-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA).25) The composition of any one of claims 19-24, wherein the viral condition is cervical dysplasia, cervical cancer, Covid-19, Epstein Barr virus infection, human papillomavirus infection, or herpes simplex virus infection.26) The composition of any one of claims 19-24, wherein the composition is in a form of a lotion, cream, oil, balm, gel, injectable solution, or oral tincture.27) A method of treating a viral condition in a subject in need thereof, the method comprises administering to the subject a therapeutic dose of a composition according to any one of claims 19-27.

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