Therapeutic composition

Abstract

Compositions of fatty acids (e.g., including one or more C4 to C40 fatty acids, e.g., C4 to C20 fatty acids) and one or more amino acids (particularly one or more amino acids having a charged basic side chain, e.g., arginine, lysine, etc. The compositions can be used in particular as antibacterial agents, and in some variations as antiviral, antifungal and anticancer compositions.

Description

[0001] This application is a divisional application of the Chinese invention patent application with an application date of October 1, 2019, application number 201980077648.X, and invention name “Therapeutic Composition”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This patent application claims priority to: U.S. Provisional Application No. 62 / 739,844, filed on October 1, 2018, entitled “Anti-Pathogenic Therapeutic Compositions”; U.S. Provisional Patent Application No. 62 / 845,858, filed on May 9, 2019, entitled “Therapeutic Compositions”; U.S. Provisional Patent Application No. 62 / 845,859, filed on May 9, 2019, entitled “Therapeutic Compositions”. Each of these applications is incorporated herein by reference in its entirety.

[0004] Incorporated by Reference

[0005] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0006] Compositions of fatty acids (e.g., C4-C40 fatty acids, C4-C20 fatty acids, C8-C20 fatty acids, including but not limited to capric acid, caprylic acid and undecylenic acid, etc.) and amino acids (e.g., amino acids with charged basic side chains, including but not limited to L-arginine and L-lysine) and treatment methods using the same, for example, for anti-pathogen (anti-bacterial, anti-viral, anti-fungal, anti-microbial) and anti-cancer purposes. Background Art

[0007] Pathogens, such as bacteria, viruses, or other microorganisms that can cause disease, are becoming increasingly difficult to treat, especially with the increasing emergence of antibiotic-resistant forms of pathogens. The Centers for Disease Control (CDC) in the United States publishes a list of pathogenic threats, many of which include drug-resistant microorganisms and microorganisms for which no effective drug therapy exists. For example, bacterial infections of the skin and underlying tissues have become a major clinical treatment problem. These types of infections typically involve Gram-positive bacteria that colonize the skin and underlying tissues, and symptoms range from mild discomfort to death. Bacteria cause many skin diseases, such as impetigo, cellulitis, boils, and acne. Deep tissue infections of surgical or traumatic wounds can invade the blood vessels, leading to sepsis and death.

[0008] Currently, many skin infections caused by Gram-positive bacteria are actively treated with antibiotics. However, as pathogenic bacterial strains develop antibiotic resistance mechanisms, it is critical to develop new therapies that do not use traditional antibiotics to inhibit bacterial growth. In recent years, with the emergence of so-called "superbugs" such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE), the problem of bacterial resistance to antibiotics has been increasingly recognized. These bacteria are common skin pathogens that develop significant antibiotic resistance. With the continued use of antibiotics in humans and animals raised for consumption, many common skin bacterial strains are developing widespread antibiotic resistance, leading to serious health care problems. Common bacteria involved in skin infections are methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes (S.pyogenes) and Streptococcus pneumoniae (S.pneumoniae), Enterococcus faecalis (E.faecalis) and Streptococcus agalactiae (S.agalactiae). When these bacteria colonize the skin, they break down the epidermis, causing an inflammatory response and, if left untreated, can invade deeper tissues, causing cellulitis. In extreme cases, the bacteria invade the circulatory system, causing sepsis and potentially death.

[0009] It is clear to the medical community that new treatments must be developed to address this problem. However, many pharmaceutical companies are not actively pursuing the development of new antimicrobial therapies for skin and wound infections.

[0010] In recent years, the number of people suffering from cancer and multidrug-resistant infections has increased, making these two diseases already recognized as the main causes of death in the present and future. In addition, chronic infection is one of the main causes of cancer due to the instability of the immune system that allows cancer cells to proliferate. Similarly, physical weakness related to cancer or anticancer therapy itself often provides a pathway for opportunistic infections. There is an urgent need to develop new treatments with higher efficacy and lower side effects. In particular, it would be beneficial to provide anti-pathogenic agents that may also have anti-cancer benefits.

[0011] Described herein are compounds and methods of using them to treat pathogens, including gram-negative and gram-positive bacteria, fungi and viruses. These compounds may also be used to treat cancer, and methods of treating or preventing cancer are also described. Summary of the invention

[0012] The present invention relates to a composition of fatty acids and amino acids used as therapeutic compositions. Examples of fatty acids include unsaturated fatty acids (e.g., undecylenic acid (UCA)) and saturated fatty acids (e.g., lauric acid). Examples of amino acids include aliphatic amino acids (e.g., L-arginine (LARG)), aromatic amino acids (e.g., histidine) and imino amino acids (e.g., proline) and amino acids with charged basic side chains (e.g., arginine, histidine and lysine). In some variations, the amino acid can be arginine (e.g., LARG) and / or lysine. These compositions can be selected for relatively high chemical stability, particularly at lower temperatures, and relatively long shelf life, as well as high efficiency and high safety.

[0013] Also described herein are methods of treating patients using these compositions, including for treating infectious diseases, such as antipathogenic compositions and / or anticancer compositions. Antipathogenics may include antimicrobial, antibacterial, antifungal, antiviral, etc. Anticancer may include antitumor, antiproliferative, anti-vegetative, etc. These compositions may be particularly useful as antibacterial, antiviral, and in some variations as anticancer compositions. The composition may be used for topical application. For example, in some variations, they may be applied to the skin (skin application) to produce a local (topical application) or systemic (systemic application) effect, including delivery through the skin (transdermal) via a patch for systemic effect. In some variations, they may be applied orally, and in some variations, they may be administered by injection (e.g., intravenous, intramuscular, intrathecal, subcutaneous, etc.). In some variations, they may be administered sublingually or between the gums and cheeks (e.g., oral cavity). In some variations, they may be administered rectally or vaginally. In some variations, they may be administered intraocularly and / or through the optic nerve. In some variations, they can be sprayed into the nose and absorbed through the nasal membranes (nasally) and / or inhaled into the lungs, usually through the mouth (by inhalation) or both the mouth and nose (by nebulization).

[0014] In general, therapeutic compositions are described herein that include fatty acids and amino acids, particularly C4-C20 fatty acids and amino acids, such as amino acids with charged basic side chains; for example, therapeutic compositions of undecylenic acid and L-arginine are described herein, and their ratios are within a working range to produce anti-pathogenic and / or anti-cancer effects (e.g., a molar ratio of fatty acid to amino acid of about 1:0.6 to about 1:1.6, such as between about 1:0.7 to about 1:1.6). For example, therapeutic compositions are described herein that include a mixture of undecylenic acid:L-arginine in a ratio of about 1:0.6 to about 1:1.6. In some variations, the therapeutic composition includes a mixture of undecylenic acid:L-arginine in a ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not include cetyl alcohol. The compositions described herein may not include any organic solvents. In some variations, the therapeutic composition comprises a mixture of undecylenic acid:L-arginine in a ratio of about 1:0.6 to about 1:1, wherein the concentration of L-arginine is from 0.01 mg / mL to 182 mg / mL.

[0015] The ratio of undecenoic acid: L-arginine can be between 1:0.6 and about 1:1. In some variations, the ratio of fatty acid to amino acid (e.g., undecenoic acid: L-arginine) is about a 1:1 molar ratio. In other variations, the ratio of fatty acid to amino acid (e.g., undecenoic acid: L-arginine) is about a 5:4 molar ratio. Any of these compositions can be an aqueous composition. The pH of the composition can be, for example, between about 6 and about 10; in some variations, the pH is between about 6.9 and about 7.8.

[0016] The fatty acids and amino acids described herein can form a complex of fatty acids and amino acids. Any composition of fatty acids and amino acids described herein can be a composition comprising a complex of fatty acids and amino acids (also referred to as a fatty acid / amino acid complex), such as a complex of UCA and LARG, etc.).

[0017] In variations where the amino acid is L-arginine, the concentration of L-arginine (LARG) can be less than the solubility limit of LARG. For example, the concentration of L-arginine can be about 182 mg / mL or less. In any of these variations, the concentration of L-arginine can be between about 0.01 mg / mL and about 182 mg / mL. Similarly, the composition of any other additional or alternative amino acids (e.g., lysine, histidine, etc.) can be less than the solubility limit of the amino acid.

[0018] Typically, the composition may include an excipient, diluent or carrier (excluding cetyl alcohol in some variations). The excipient, diluent or carrier may be configured for topical application. In some variations, the excipient, diluent or carrier may include an emulsifier. Any of these compositions may include a cooling or heating additive.

[0019] The composition can be configured as a liquid or emulsion in a form suitable for topical application to humans. For example, the composition can be configured for one or more of the following: oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalation, and topical administration. The composition can be configured for coating medical devices.

[0020] Also described herein are methods of treating one or more of: infection (e.g., pathogens, such as bacteria, yeast, viruses, etc.) and / or cancer in a patient. For example, a method of treating a patient to destroy a pathogen may include administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of fatty acids (e.g., C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19, or C20 fatty acids) and amino acids (e.g., L-arginine, lysine, histidine, etc.), such as, but not limited to, a mixture of undecenoic acid:L-arginine in a ratio of about 1:0.6 to about 1:1.6.

[0021] In some variations, a method of treating a patient with an anti-pathogenic composition to destroy a pathogen may include administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of fatty acids (e.g., C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19 or C20 fatty acids) and amino acids (e.g., L-arginine, lysine, histidine, etc.), such as but not limited to a mixture of undecylenic acid:L-arginine in a ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

[0022] A method of treating a patient with an anti-pathogenic composition to destroy a pathogen may include administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of fatty acids (e.g., C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19 or C20 fatty acids) and amino acids (e.g., L-arginine, lysine, histidine, etc.), such as, but not limited to, a mixture of undecenoic acid:L-arginine in a ratio of about 1:0.6 to about 1:1.6, wherein the concentration of the amino acid (e.g., L-arginine) is 0.01 mg / mL to 182 mg / mL.

[0023] Also described herein are methods of treating cancer, comprising administering to a patient in need thereof (e.g., a patient with cancer) a therapeutically effective amount of a composition comprising a mixture of fatty acids (e.g., C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19 or C20 fatty acids) and amino acids (e.g., L-arginine, histidine, lysine, etc.), such as, but not limited to, a mixture of undecylenic acid:L-arginine in a ratio of about 1:0.6 to about 1:1. In some variations, the concentration of the amino acid (e.g., L-arginine) is between 0.01 mg / mL and 182 mg / mL.

[0024] In any of these methods and compositions, the ratio of fatty acids to amino acids can be about a 1:1 or 5:4 molar ratio. For UCA:LARG, the ratios are about 1:0.95 and 1:0.76 by weight, respectively, which provide both efficacy and enhanced chemical stability, allowing the fatty acids and amino acids to remain in solution for a long time over time, especially at low temperatures, including -20 degrees Celsius.

[0025] In any of these methods, the antipathogenic composition can be an aqueous composition. The pH of the antipathogenic composition can be between about 6 and about 10. For example, the pH of the antipathogenic composition can be between about 6.9 and about 7.8.

[0026] In any of these methods, the concentration of the amino acid (e.g., L-arginine) in the composition can be 182 mg / mL or less, for example, the concentration of the amino acid (e.g., L-arginine) can be between 0.01 mg / mL and 182 mg / mL.

[0027] Administration may include applying the antipathogenic composition to the patient's skin. In some variations, administration includes applying the antipathogenic composition to a patient's wound. In some variations, administration includes systemically applying the antipathogenic composition to the patient. In some variations, administration includes spraying the antipathogenic composition on the patient. In some variations, administration includes releasing the antipathogenic composition from a medical device. For example, administration may include contacting the patient with a surface of a medical device comprising the antipathogenic composition.

[0028] The composition (e.g., antipathogenic composition, anticancer composition, etc.) may further comprise an excipient, diluent or carrier, except cetyl alcohol; the excipient, diluent or carrier may be configured for topical application. The excipient, diluent or carrier may comprise an emulsifier.

[0029] Any of these compositions (eg, anti-pathogenic compositions, anti-cancer compositions, etc.) may further comprise cooling or heating additives, and / or may be formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0030] The present invention also relates to the following items:

[0031] 1. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6.

[0032] 2. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

[0033] 3. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

[0034] 4. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are amino acids with charged basic side chains.

[0035] 5. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

[0036] 6. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

[0037] 7. The composition of any one of items 1-6, wherein the molar ratio of fatty acid:amino acid is from 1:0.6 to about 1:1.

[0038] 8. The composition of any one of items 1-6, wherein the molar ratio of fatty acid:amino acid is about 1:1 molar ratio.

[0039] 9. The composition of any one of items 1-6, wherein the molar ratio of fatty acid:amino acid is about 5:4 molar ratio.

[0040] 10. The composition of any one of items 1-9, wherein the composition is an aqueous composition.

[0041] 11. The composition of any one of items 1-10, wherein the pH is between 6 and 10.

[0042] 12. The composition of any one of items 1-10, wherein the pH is between 6.9 and 7.8.

[0043] 13. The composition of any one of items 1-12, further comprising an excipient, a diluent or a carrier.

[0044] 14. The composition of claim 13, wherein the excipient, diluent or carrier is configured for topical administration.

[0045] 15. The composition of claim 13, wherein the excipient, diluent or carrier comprises an emulsifier.

[0046] 16. The composition of any one of items 1 to 15, further comprising a cooling or heating additive.

[0047] 17. The composition of any one of items 1-16, wherein the composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0048] 18. The composition of any one of items 1-16, wherein the composition is configured for one or more of the following: oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalable, and topical administration.

[0049] 19. The composition of any one of items 1 to 16, wherein the composition is configured for coating a medical device.

[0050] 20. A method of treating a patient to destroy a pathogen, the method comprising: administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6.

[0051] 21. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of fatty acids: amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

[0052] 22. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of fatty acids: amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

[0053] 23. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are amino acids with charged basic side chains.

[0054] 24. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

[0055] 25. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

[0056] 26. The method of any one of items 20-25, wherein the molar ratio of fatty acid:amino acid is approximately a 1:1 molar ratio.

[0057] 27. The method of any one of items 20-25, wherein the molar ratio of fatty acid:amino acid is approximately a 5:4 molar ratio.

[0058] 28. The method of any one of items 20-27, wherein the anti-pathogenic composition is an aqueous composition.

[0059] 29. The method of any one of items 20-28, wherein the pH of the anti-pathogenic composition is between 6 and 10.

[0060] 30. The method of any one of items 20-28, wherein the pH of the anti-pathogenic composition is between 6.9 and 7.8.

[0061] 31. The method of any one of items 20-30, wherein administering comprises applying the anti-pathogenic composition to the skin of the patient.

[0062] 32. The method of any one of items 20 to 30, wherein administering comprises applying the anti-pathogenic composition to a wound of the patient.

[0063] 33. The method of any one of items 20 to 30, wherein administration comprises systemically administering the anti-pathogenic composition to the patient.

[0064] 34. The method of any one of items 20 to 30, wherein administering comprises spraying the anti-pathogenic composition on the patient.

[0065] 35. The method of any one of items 20-30, wherein administering comprises releasing the anti-pathogenic composition from a medical device.

[0066] 36. The method of any one of items 20-30, wherein administration comprises contacting the patient with a surface of a medical device comprising the anti-pathogenic composition.

[0067] 37. The method of any one of items 20-25, wherein the pathogen is one or more of the following: Gram-negative bacteria, Gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli, viruses.

[0068] 38. The method of any one of items 20-25, wherein the anti-pathogenic composition further comprises an excipient, diluent or carrier, but excluding cetyl alcohol.

[0069] 39. The method of claim 38, wherein the excipient, diluent or carrier is configured for topical administration.

[0070] 40. The method of claim 38, wherein the excipient, diluent or carrier comprises an emulsifier.

[0071] 41. The method of any one of items 20-25, wherein the anti-pathogenic composition further comprises a cooling or heating additive.

[0072] 42. The method of any one of items 20-25, wherein the antipathogenic composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0073] 43. A method of treating a patient to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of a therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6.

[0074] 44. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

[0075] 45. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

[0076] 46. ​​A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the amino acids are amino acids with charged basic side chains.

[0077] 47. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

[0078] 48. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

[0079] 49. The method of any one of items 43-48, wherein the molar ratio of fatty acid:amino acid is about a 1:1 molar ratio.

[0080] 50. The method of any one of items 43-48, wherein the molar ratio of fatty acid:amino acid is approximately a 5:4 molar ratio.

[0081] 51. The method of any one of items 43-50, wherein the therapeutic composition is an aqueous composition.

[0082] 52. The method of any one of items 43-51, wherein the pH of the therapeutic composition is between 6 and 10.

[0083] 53. The method of any one of items 43-51, wherein the pH of the therapeutic composition is between 6.9 and 7.8.

[0084] 54. The method of any one of items 43-53, wherein administering comprises applying the therapeutic composition to the skin of the patient.

[0085] 55. The method of any one of items 43-53, wherein administration comprises systemically administering the therapeutic composition to the patient.

[0086] 56. The method of any one of items 43-53, wherein administration comprises releasing the therapeutic composition from a medical device.

[0087] 57. The method of any one of items 43-53, wherein administration comprises contacting the patient with a surface of a medical device comprising the therapeutic composition.

[0088] 58. The method of any one of items 43-48, wherein the therapeutic composition further comprises an excipient, diluent or carrier, but other than cetyl alcohol.

[0089] 59. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of: L-arginine, histidine, and lysine.

[0090] 60. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C40 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

[0091] 61. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

[0092] 62. The therapeutic composition of items 59-61, wherein the fatty acid is one or more of the following: caprylic acid, nonanoic acid, capric acid, undecylenic acid, lauric acid, tridecanoic acid, myristic acid, linoleic acid, arachidonic acid and arachidic acid.

[0093] 63. The therapeutic composition of items 59-61, wherein the total concentration of the fatty acid:amino acid mixture is from about 35% to about 0.001% w / w.

[0094] 64. The therapeutic composition of items 59-61, wherein the molar ratio of fatty acid:amino acid is between 1:0.6 and approximately 1:1.

[0095] 65. The therapeutic composition of items 59-61, wherein the molar ratio of fatty acid:amino acid is about a 1:1 molar ratio.

[0096] 66. The therapeutic composition of items 59-61, wherein the molar ratio of fatty acid:amino acid is about a 5:4 molar ratio.

[0097] 67. The therapeutic composition of items 59-61, wherein the composition is an aqueous composition.

[0098] 68. The therapeutic composition of items 59-61, wherein the pH is between 6 and 10.

[0099] 69. The therapeutic composition of items 59-61, wherein the pH is between 6.9 and 7.8.

[0100] 70. The therapeutic composition of items 59-61, further comprising an excipient, diluent or carrier.

[0101] 71. The therapeutic composition of claim 70, wherein the excipient, diluent or carrier is configured for topical administration.

[0102] 72. The therapeutic composition of claim 70, wherein the excipient, diluent or carrier comprises an emulsifier.

[0103] 73. The therapeutic composition of items 59-61, further comprising a cooling or heating additive.

[0104] 74. The therapeutic composition of items 59-61, wherein the composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0105] 75. The therapeutic composition of items 59-61, wherein the composition is configured for one or more of: oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalation, and topical administration.

[0106] 76. The therapeutic composition of items 59-61, wherein the composition is configured for coating a medical device.

[0107] 77. A method of treating a patient to destroy a pathogen, the method comprising: administering to a patient in need thereof a therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of: arginine, histidine, and lysine.

[0108] 78. A method of treating a patient to destroy a pathogen, the method comprising: administering to a patient in need thereof a therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

[0109] 79. The method described in items 77-78, wherein the fatty acid is one or more of the following: caprylic acid, nonanoic acid, capric acid, undecylenic acid, lauric acid, tridecanoic acid, myristic acid, linoleic acid, arachidonic acid and arachidic acid.

[0110] 80. The method of items 77-78, wherein the molar ratio of fatty acid:amino acid is about 1:1 molar ratio.

[0111] 81. The method described in items 77-78, wherein the molar ratio of fatty acid:amino acid is about 5:4 molar ratio.

[0112] 82. The method of items 77-78, wherein the composition is an aqueous composition.

[0113] 83. The method of items 77-78, wherein the pH of the composition is between 6 and 10.

[0114] 84. The method of items 77-78, wherein the pH of the composition is between 6.9 and 7.8.

[0115] 85. The method described in items 77-78, wherein administering comprises applying the composition to the skin of the patient.

[0116] 86. The method described in items 77-78, wherein administering comprises applying the composition to a wound of the patient.

[0117] 87. The method described in items 77-78, wherein administration comprises systemically administering the composition to the patient.

[0118] 88. The method of items 77-78, wherein administration comprises spraying the composition on the patient.

[0119] 89. The method of items 77-78, wherein administration comprises releasing the composition from a medical device.

[0120] 90. The method of items 77-78, wherein administration comprises contacting the patient with a surface of a medical device comprising the composition.

[0121] 91. The method described in items 77-78, wherein the pathogen is one or more of the following: Gram-negative bacteria, Gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli bacteria and viruses.

[0122] 92. The method of items 77-78, wherein the composition further comprises an excipient, diluent or carrier, but excluding cetyl alcohol.

[0123] 93. The method of claim 92, wherein the excipient, diluent or carrier is configured for topical administration.

[0124] 94. The method of claim 92, wherein the excipient, diluent or carrier comprises an emulsifier.

[0125] 95. The method described in items 77-78, wherein the composition further comprises a cooling or heating additive.

[0126] 96. The method described in items 77-78, wherein the composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0127] 97. A method of treating cancer, comprising: administering to a patient in need thereof a therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of the following: arginine, histidine, and lysine.

[0128] 98. A method for treating cancer, comprising: administering to a patient in need thereof a therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

[0129] 99. The method described in items 97-98, wherein the fatty acid is one or more of the following: caprylic acid, nonanoic acid, capric acid, undecylenic acid, lauric acid, tridecanoic acid, myristic acid, linoleic acid, arachidonic acid and arachidic acid.

[0130] 100. The method described in items 97-98, wherein the molar ratio of fatty acid:amino acid is about a 1:1 molar ratio.

[0131] 101. The method described in items 97-98, wherein the molar ratio of fatty acid:amino acid is about 5:4 molar ratio.

[0132] 102. The method described in items 97-98, wherein the composition is an aqueous composition.

[0133] 103. The method described in items 97-98, wherein the pH of the composition is 6 to 10.

[0134] 104. The method described in items 97-98, wherein the pH of the composition is between 6.9 and 7.8.

[0135] 105. The method described in items 97-98, wherein administering comprises applying the composition to the skin of the patient.

[0136] 106. The method described in items 97-98, wherein administering comprises applying the composition to a wound of the patient.

[0137] 107. The method described in items 97-98, wherein administration comprises systemically administering the composition to the patient.

[0138] 108. The method described in items 97-98, wherein administration comprises spraying the composition on the patient.

[0139] 109. The method of items 97-98, wherein administration comprises releasing the composition from a medical device.

[0140] 110. The method described in items 97-98, wherein administration comprises contacting the patient with a surface of a medical device comprising the composition.

[0141] 111. The method described in items 97-98, wherein the pathogen is one or more of the following: Gram-negative bacteria, Gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli bacteria and viruses.

[0142] 112. The method of items 97-98, wherein the composition further comprises an excipient, diluent or carrier, but other than cetyl alcohol.

[0143] 113. The method of claim 112, wherein the excipient, diluent or carrier is configured for topical administration.

[0144] 114. The method of claim 112, wherein the excipient, diluent or carrier comprises an emulsifier.

[0145] 115. The method described in items 97-98, wherein the composition further comprises a cooling or heating additive.

[0146] 116. The method described in items 97-98, wherein the composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0147] 117. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6.

[0148] 118. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

[0149] 119. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine at a total concentration of about 35% to about 0.001% w / w and a molar ratio of about 1:0.6 to about 1:1.

[0150] 120. A therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6.

[0151] 121. A therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

[0152] 122. A therapeutic composition comprising a mixture of capric acid:L-arginine at a total concentration of about 35% to about 0.001% w / w and a molar ratio of about 1:0.6 to about 1:1.

[0153] 123. The composition of any one of items 117-119, wherein the molar ratio of undecylenic acid:L-arginine is from 1:0.6 to about 1:1.

[0154] 124. The composition of any one of items 117-119, wherein the molar ratio of undecylenic acid:L-arginine is about a 1:1 molar ratio.

[0155] 125. The composition of any one of items 117-119, wherein the molar ratio of undecylenic acid:L-arginine is a molar ratio of about 5:4.

[0156] 126. The composition of any one of items 120-122, wherein the molar ratio of capric acid:L-arginine is 1:0.6 to about 1:1.

[0157] 127. The composition of any one of items 120-122, wherein the molar ratio of capric acid:L-arginine is about a 1:1 molar ratio.

[0158] 128. The composition of any one of items 120-122, wherein the molar ratio of capric acid:L-arginine is a molar ratio of about 5:4.

[0159] 129. The composition of any one of items 117-128, wherein the composition is an aqueous composition.

[0160] 130. A composition as described in any of items 117-129, wherein the pH is between 6 and 10.

[0161] 131. The composition of any of items 117-130, wherein the pH is between 6.9 and 7.8.

[0162] 132. The composition of any one of items 117-131, further comprising an excipient, a diluent or a carrier.

[0163] 133. The composition of claim 132, wherein the excipient, diluent or carrier is configured for topical administration.

[0164] 134. The composition of claim 132, wherein the excipient, diluent or carrier comprises an emulsifier.

[0165] 135. The composition of any one of items 117-134, further comprising a cooling or heating additive.

[0166] 136. The composition of any one of items 117-135, wherein the composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0167] 137. The composition of any of items 117-136, wherein the composition is configured for one or more of: oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalation and topical administration.

[0168] 138. A composition according to any one of items 117-137, wherein the composition is configured for coating a medical device.

[0169] 139. A method of treating a patient to destroy a pathogen, the method comprising: administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.6.

[0170] 140. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not contain cetyl alcohol.

[0171] 141. A method for treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of undecylenic acid:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of the following: L-arginine, lysine and histidine.

[0172] 142. A method of treating a patient to destroy a pathogen, the method comprising: administering to the patient a therapeutically effective amount of an anti-pathogenic composition comprising a mixture of capric acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.6.

[0173] 143. A method of treating a patient with an anti-pathogenic composition to destroy pathogens, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of capric acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the therapeutic composition does not contain cetyl alcohol.

[0174] 144. A method of treating a patient with an anti-pathogenic composition to destroy a pathogen, the method comprising: administering to the patient a therapeutically effective amount of the anti-pathogenic composition, the anti-pathogenic composition comprising a mixture of capric acid:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of the following: L-arginine, lysine and histidine.

[0175] 145. The method of any one of items 139-144, wherein the molar ratio of undecylenic acid:L-arginine or undecylenic acid:amino acid or capric acid:L-arginine or capric acid:amino acid is about a 1:1 molar ratio.

[0176] 146. The method of any one of items 138-143, wherein the molar ratio of undecylenic acid:L-arginine or undecylenic acid:amino acid or capric acid:L-arginine or capric acid:amino acid is a molar ratio of about 5:4.

[0177] 147. The method of any one of items 139-146, wherein the anti-pathogenic composition is an aqueous composition.

[0178] 148. The method of any one of items 139-147, wherein the pH of the anti-pathogenic composition is between 6 and 10.

[0179] 149. The method of any one of items 139-148, wherein the pH of the anti-pathogenic composition is between 6.9 and 7.8.

[0180] 150. The method of any one of items 139-149, wherein administration comprises applying the anti-pathogenic composition to the skin of the patient.

[0181] 151. The method of any one of items 139-150, wherein administration comprises applying the anti-pathogenic composition to a wound of the patient.

[0182] 152. The method of any one of items 139-151, wherein administration comprises systemically administering the anti-pathogenic composition to the patient.

[0183] 153. The method of any one of items 139-152, wherein administration comprises spraying the anti-pathogenic composition onto the patient.

[0184] 154. The method of any one of items 139-153, wherein administration comprises releasing the anti-pathogenic composition from a medical device.

[0185] 155. The method of any one of items 139-154, wherein administration comprises contacting the patient with a surface of a medical device comprising the anti-pathogenic composition.

[0186] 156. The method of any one of items 139-155, wherein the pathogen is one or more of the following: Gram-negative bacteria, Gram-positive bacteria, fungi, mycobacteria, pneumococcal bacteria, Escherichia coli and viruses.

[0187] 157. The method of any one of items 139-156, wherein the anti-pathogenic composition further comprises an excipient, diluent or carrier, but other than cetyl alcohol.

[0188] 158. The method of claim 157, wherein the excipient, diluent or carrier is configured for topical administration.

[0189] 159. The method of claim 157, wherein the excipient, diluent or carrier comprises an emulsifier.

[0190] 160. The method of any one of items 139-159, wherein the anti-pathogenic composition further comprises a cooling or heating additive.

[0191] 161. The method of any one of items 139-160, wherein the anti-pathogenic composition is formulated as a liquid or emulsion in a form suitable for topical administration to humans.

[0192] 162. A method of treating a patient to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of a therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6.

[0193] 163. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not contain cetyl alcohol.

[0194] 164. A method of treating a patient to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of a therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6.

[0195] 165. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: administering to the patient a therapeutically effective amount of the therapeutic composition, the therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not contain cetyl alcohol.

[0196] 166. The method of any one of items 162-165, wherein the molar ratio of undecylenic acid:L-arginine or capric acid:L-arginine is about a 1:1 molar ratio.

[0197] 167. The method of any one of items 162-165, wherein the molar ratio of undecylenic acid:L-arginine or capric acid:L-arginine is a molar ratio of about 5:4.

[0198] 168. The method of any one of items 162-167, wherein the therapeutic composition is an aqueous composition.

[0199] 169. The method of any one of items 162-168, wherein the pH of the therapeutic composition is between 6 and 10.

[0200] 170. The method of any one of items 162-169, wherein the pH of the therapeutic composition is between 6.9 and 7.8.

[0201] 171. The method of any of items 162-170, wherein administration comprises applying the therapeutic composition to the skin of the patient.

[0202] 172. The method of any one of items 162-171, wherein administration comprises systemically administering the therapeutic composition to the patient.

[0203] 173. The method of any of items 162-172, wherein administration comprises releasing the therapeutic composition from a medical device.

[0204] 174. The method of any of items 162-173, wherein administration comprises contacting the patient with a surface of a medical device comprising the therapeutic composition.

[0205] 175. The method of any of items 162-174, wherein the therapeutic composition further comprises an excipient, diluent or carrier, but other than cetyl alcohol. BRIEF DESCRIPTION OF THE DRAWINGS

[0206] The novel features of the present invention are specifically described in the attached project specification. The features and advantages of the present invention may be better understood by referring to the following detailed description in conjunction with the accompanying drawings, which describe illustrative embodiments in which the principles of the present invention are utilized, wherein:

[0207] Figure 1 is a graph showing the antibacterial effects of various compositions including LARG and UCA.

[0208] Figure 2A-2B is a graph showing the inhibitory effect of cetyl alcohol (CA) on the ability of LARG and UCA compositions to prevent bacterial growth.

[0209] Figure 3 is a table showing the solubility of UCA:LARG above the solubility limit of LARG (Table 1).

[0210] Figure 4 is a table showing the solubility of UCA:LARG where LARG is below the solubility limit (Table 2).

[0211] Figure 5 is a graph showing the bactericidal effect of various ratios of UCA:LARG against three MRSA isolates.

[0212] Figure 6 Is displayed in the ratio Figure 5 At a smaller scale, plots of the bactericidal effects of various ratios of UCA:LARG against three MRSA isolates.

[0213] Figure 7 Is displayed in the ratio Figure 5 and Figure 6 At a smaller scale, plots of the bactericidal effects of various ratios of UCA:LARG against three MRSA isolates.

[0214] Figure 8-11 Shown are the mean bacterial concentrations obtained from three MRSA isolates (MRSA 10, 11 and 12) as a function of the UCA:LARG ratio. Figure 8 The y-axis (bacterial concentration, in CFU / mL) is scaled logarithmically to 140,000,000 (1.4×10 8 )CFU / mL concentration. Fig. 9 Display and Figure 8 The same data, but with the y-axis expanded to 1,000,000 (1.0×10 6 )CFU / mL. Fig.10 The display is expanded to 100,000 (1.0×10 5 )The same data on the y-axis with CFU / mL. Fig.11 The display is expanded to 30,000 (3.0×10 4 )The same data on the y-axis with CFU / mL.

[0215] Fig.12 is a graph showing the pH of various compositions comprising different ratios of UCA:LARG in water.

[0216] Fig.13 is a graph showing the in vitro efficacy of one variation of the compounds described herein (referred to as "GS-1") against eight methicillin-resistant Staphylococcus aureus (MRSA) isolates at a drug dilution of 1:16. MRSA is Gram-positive.

[0217] Fig.14 is a graph illustrating the efficacy of GS-1 compound against two Escherichia coli (EC) isolates at a drug dilution of 1: 16. EC is Gram-negative.

[0218] Fig.15 is an example of a graph illustrating the in vitro efficacy of GS-1 against three CRE-positive Klebsiella pneumoniae (KPCRE) isolates at a drug dilution of 1 : 16. KPCRE is Gram-negative.

[0219] Fig.16 The in vitro efficacy of GS-1 against two isolates of Pseudomonas aeruginosa (PSA) at a drug dilution of 1:8 is demonstrated. PSA is Gram-negative.

[0220] Fig.17 Shown is the in vitro efficacy of GS-1 against C6 rat glioma cancer cells as a function of drug dilution.

[0221] Figures 18A-18E Shown are microscopic images of the in vitro efficacy of GS-1 against C6 rat glioma cancer cells as a function of drug dilution. Fig.18A Shown are cells treated with GS-1 at a 1:64 dilution, showing the greatest amount of cell death. Fig.18B Cells treated with GS-1 at a 1:128 dilution are shown. Fig.18C Cells treated with GS-1 at a 1:256 dilution are shown. Fig.18D Cells treated with GS-1 at a 1:512 dilution are shown. Fig.18E An untreated control group is shown.

[0222] Fig.19 is a table showing the results of freeze stability studies of exemplary compositions described herein.

[0223] Fig. 20 is a graph illustrating the therapeutic effects of four fatty acid:amino acid compositions having a weight ratio of about 1:0.76 (fatty acid:amino acid) when diluted and used to treat MRSA. GS-1 corresponds to UCA:LARG (molar ratio of 1:0.8) as described above, which is a 1:128 dilution of an approximately 32% w / w mixture, resulting in a concentration of about 0.25% total active pharmaceutical ingredient (API). GS-2 corresponds to a mixture of capric acid:LARG (molar ratio of about 1:0.8), a 1:128 dilution of an approximately 32% w / w mixture, resulting in a total API concentration of about 0.25%. GS-3 corresponds to a mixture of caprylic acid:LARG (molar ratio of about 1:0.6), a 1:128 dilution of an approximately 32% w / w mixture, resulting in a total API concentration of about 0.25%. GS-4 corresponds to a linoleic acid:LARG mixture having a total API concentration of about 1.64 mg / mL (0.16% w / w), a molar ratio of about 1:6.1.

[0224] Fig.21 is a graph showing the 24 hour activity of GS-2 (decanoic acid:LARG, total API concentration of about 0.25% w / w, molar ratio of about 1:0.8) against six MRSA clinical isolates compared to a saline treated control. The decanoic acid:LARG composition produced bactericidal effects in 100% of the isolates.

[0225] Fig. 22 is a graph showing the activity of GS-3 (octanoic acid:LARG, total API concentration of about 0.25% w / w, molar ratio of about 1:0.6) against six MRSA clinical isolates over 24 hours compared to a saline treated control. The octanoic acid:LARG combination produced an inhibitory effect against 66.7% of the isolates and a bacteriostatic effect against 33.3% of the isolates.

[0226] Fig.23 : is a graph showing the activity of GS-4 (linoleic acid:LARG, total API concentration of about 0.16% w / w, molar ratio of about 1:6.1) against six MRSA clinical isolates for 24 hours compared to saline treated controls. GS-4 produced bactericidal effects in 50% of the isolates and inhibitory effects in 50% of the isolates.

[0227] Fig.24 is a graph showing the activity of GS-5 (UCA:Lysine, total API concentration of about 0.25% w / w, molar ratio of about 1:1.0) against five MRSA clinical isolates over 24 hours compared to saline treated controls. GS-5 produced bactericidal effects against all isolates at this concentration.

[0228] Fig.25 is a graph showing the activity of GS-6 (UCA:histidine) at a molar ratio of about 1:0.8 (e.g. 5:4). The weight ratio is about 1:0.76. As shown, using histidine as the amino acid also shows significant levels of activity. Preliminary results suggest that using UCA:lysine and UCA:L-arginine have similar ranges of efficacy.

[0229] Fig.26 is a table matrix showing the results of testing various amino acid and fatty acid combinations. Exemplary C4-C20 fatty acids are listed in the columns, while amino acids (grouped by properties) are shown at the top. Negative and positive results are shown in corresponding boxes, wherein a negative result indicates that no solution is formed and / or there is no significant anti-pathogenic / anti-cancer effect. A positive result indicates that the combination of amino acids and fatty acids forms a therapeutic composition, for example, the molar ratio of fatty acid: amino acid is about 1:0.6 to about 1:1.6. Question marks, (-) and (+) indicate preliminary tests, while "yes" or "no" indicates confirmed data.

[0230] Fig. 27 is a graph showing the anti-cancer efficacy of a therapeutic composition of an agent comprising a mixture of fatty acids and amino acids as described herein, wherein the molar ratio of fatty acids:amino acids is from about 1:0.6 to about 1:1.6; in this example, the agent is a GS-1 solution (LARG and UCA) tested against human cancer cells at a working drug concentration of 0.3% w / w.

[0231] Fig.28 is a graph showing examples of different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 to about 1:1.6 (LARG and UCA, GS-1 in this example), on the anticancer effects of cultured PC3 human prostate cancer cells after incubation with various concentrations of the reagents for 24 hours.

[0232] Fig.29 is a graph showing examples of different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 and about 1:1.6 (LARG and UCA, GS-1 in this example), on the anticancer effects of cultured MCF7 breast cancer cells after incubation with various concentrations of the agents for 24 hours.

[0233] Fig.30 is a graph showing examples of different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 to about 1:1.6 (LARG and UCA, GS-1 in this example), on the anticancer effects of cultured MM170 human melanoma cancer cells after incubation with various concentrations of the agents for 24 hours.

[0234] Fig.31 is a graph showing examples of different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 and about 1:1.6 (LARG and UCA, GS-1 in this example), on the anticancer effects of cultured U937 human leukemia cancer cells after incubation with various concentrations of the agents for 24 hours.

[0235] Fig.32 is a graph showing examples of different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 to about 1:1.6 (LARG and UCA, GS-1 in this example), on the anticancer effects of cultured A549 human lung cancer cells after incubation with various concentrations of the agents for 24 hours.

[0236] Fig.33 is another example showing different concentrations of a mixture of fatty acids and amino acids described herein, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 and about 1:1.6 (in this example, LARG and capric acid, GS-2), and the results of anti-cancer testing of cultured A549 human lung cancer cells after incubation with various concentrations of the agents for 24 hours.

[0237] Fig.34 is a graph illustrating the in vitro antiviral activity of examples of therapeutic compositions of fatty acids and amino acids described herein at various concentrations against herpes simplex virus (HSV) infected cells, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 and about 1:1.6 (LARG and UCA, GS-1 in this example).

[0238] Fig.35is a graph illustrating the in vitro antiviral activity of examples of therapeutic compositions of fatty acids and amino acids described herein at various concentrations against pseudo-Ebola virus infected cells, wherein the molar ratio of fatty acid:amino acid is between about 1:0.6 and about 1:1.6 (LARG and UCA, GS-1 in this example). Detailed description

[0240] In general, the present invention describes a therapeutic composition comprising fatty acids (e.g., C4, C5, C6, C7, C8, C9, C10, C11, C12, C13, C14, C15, C16, C17, C18, C19 or C20 fatty acids, etc., such as one or more of undecylenic acid, capric acid, caprylic acid, linoleic acid, etc.) and amino acids (e.g., one or more of L-arginine, lysine, histidine, etc.), wherein the ratio of total fatty acids to total amino acids is in the range of about 1:0.60 to about 1:1.6 (e.g., between about 1:0.6 and 1:1.2, between about 1:0.6 and 1:1.0, about 1:<1.0, etc.). The concentration of the amino acid in the composition can be less than the solubility limit of the amino acid. In some variations, the composition can include a fatty acid to amino acid (e.g., UCA:LARG) ratio of about 1:1 molar ratio (e.g., about 1:0.95 by weight). In some variations, the composition can include a fatty acid to amino acid (e.g., UCA:LARG) ratio of about 5:4 molar ratio (e.g., about 1:0.76 by weight). These compositions can have enhanced stability and efficacy, including at temperatures of -20°C or lower for extended periods of time.

[0241] Compositions outside this range are much less effective or ineffective, and / or may be unstable. For example, PCT / US2018 / 018077, filed on February 13, 2018, entitled "Anti-Pathogenic Therapeutic Compositions," the entire contents of which are incorporated herein by reference, and US / 2015 / 0366925, filed on January 27, 2014 (PCT Application No. PCT / US14 / 13120), describe antibacterial compositions of rhubarb extracts, particularly compositions including rhein, an active ingredient of rhubarb extract. These compositions typically include L-arginine (LARG) and undecylenic acid (UCA) as auxiliary molecules in the composition, which includes other substances used for treatment that act as antimicrobial substances. It has been shown that LARG and UCA have no effect on the growth of bacteria without the addition of rhubarb extract / rhein (e.g., see US2015 / 0366925). Figure 4-7). This previous work described a drug product that included a combination of L-arginine, undecylenic acid, rhubarb / rhein, cetyl alcohol (an excipient), and water. Based on these preliminary findings, at least three components, LARG, UCA, and rhubarb extract / rhein, were required to achieve a robust therapeutic effect. This study further demonstrated that cetyl alcohol was required to bring these components into solution together. Therefore, it was thought that the best therapeutic effect would occur when all three ingredients (individually and collectively) reached the maximum achievable concentration. Therefore, LARG was always included above its solubility limit (e.g., supersaturated).

[0242] Surprisingly, the inventors have developed a composition in which only fatty acids, such as UCA, and amino acids, such as LARG, together form a very effective anti-pathogenic and anti-cancer composition, without rhubarb extract (including rhein) in the composition. In particular, described herein are compositions of virtually any C4-C40 (e.g., C4-C20, C8-C20, C8-C18, C4-C18) fatty acid with certain amino acids (e.g., arginine, histidine, lysine) (including but not limited to UCA and LARG) that have excellent stability in solution within a defined concentration range and efficacy for anti-pathogenic and / or anti-cancer therapy. In addition, any of these compositions (combinations including UCA and LARG) can be made without cetyl alcohol or other similar excipients that were previously thought to be necessary for the solubility of fatty acids and amino acids (e.g., to keep UCA and LARG together in solution). Surprisingly, excipients such as cetyl alcohol significantly inhibit the efficacy of fatty acid and amino acid (e.g., UCA and LARG) compositions. For example, the highest efficacy of the UCA / LARG composition occurs at concentrations of UCA and LARG that are well below the maximum achievable concentrations of all three components, and in particular, occurs at concentrations of LARG below its solubility limit. As described herein, the combination of fatty acids and amino acids (e.g., UCA / LARG) has significant efficacy (e.g., anti-pathogenic and / or anti-cancer efficacy) only when the UCA:LARG concentration ratio is within a specified window, which can only be achieved when LARG is at or below its solubility limit (and in the absence of rhubarb extract / rhein and / or cetyl alcohol). In addition, this optimal range (e.g., a ratio of UCA to LARG of 1 to <1, such as between about 1:0.6 and 1:1.6, such as between about 1:0.6 and 1:1) is strictly limited: at one end of the window (e.g., above about 1:1.6), efficacy drops off dramatically. At the other end of the optimal range window, solubility drops, with the solubility of the fatty acid (e.g., UCA) dropping very sharply. Within the window, the power is much greater than previously observed and yields a strong trend toward the optimum.

[0243] Combinations of UCA and LARG used previously as antimicrobial agents include rhubarb / rhein and cetyl alcohol (CA), and it was believed that rhubarb extract (rhein) and cetyl alcohol were necessary. Surprisingly, the inventors found that removing rhubarb / rhein and CA significantly improved the activity of the resulting compound; this improvement was more pronounced when the ratio of UCA:LARG was adjusted to between about 1:0.6 and 1:1.6. This was unexpected, as rhein has antimicrobial activity, and CA is a well-accepted excipient (and therefore should not affect efficacy).

[0244] For example, Figure 1 The antimicrobial effects of various compositions including UCA and LARG against three MRSA isolates were shown. Figure 1 In the present invention, an exemplary composition "WT13-13" comprises UCA, LARG, rhein, CA and water; the composition of UCA+LARG+CA does not contain rhein (has water); the composition of UCA+LARG does not contain rhein and CA (has water). In all cases, the concentrations of UCA and LARG were kept constant. Efficacy is reported as the concentration of viable bacteria (in CFU / mL) retained after 24 hours of treatment with the drug product (in compliance with CLSI guidelines). In this first example, the composition comprising only UCA and LARG has a stronger antibacterial effect than the composition comprising rhubarb extract / rhein, UCA and LARG, or even the composition comprising UCA and LARG and the excipient CA. In the present invention, the composition comprising only UCA and LARG has a stronger antibacterial effect than the composition comprising rhubarb extract / rhein, UCA and LARG, or even the composition comprising UCA and LARG and the excipient CA. Figure 1 In the experiment, the ratio of UCA and LARG was not optimized.

[0245] UCA+LARG and excipient (eg, CA) compounds were further tested by varying the concentration of CA and testing the antimicrobial efficacy. Figure 2A-2B The resulting efficacy (average on three MRSA isolates) is shown. Figure 2A The full scale is shown on the y-axis (e.g., up to 8 x 10 6 CFU / mL), and Figure 2B An enlarged y-axis is shown on the y-axis to better illustrate the situation at low CA concentrations. Efficacy is reported based on the concentration of viable bacteria remaining after 24 hours of treatment (in CFU / mL). As shown in the figure, increasing amounts of CA in the UCA and LARG compositions resulted in decreased efficacy.

[0246] Thus, removal of rhubarb / rhein and CA resulted in better efficacy. In addition, CA had a significant inhibitory effect that varied with its concentration. These findings contradict previously published data showing that UCA and LARG alone (or in combination) did not show significant antimicrobial (e.g., antibacterial) effects. See, e.g., US2015 / 0366925 Figure 4-7 .

[0247] In particular, previously described compositions of UCA and LARG include tightly controlled concentrations of UCA and LARG. For example, at full strength, the concentration of LARG is 293 mg / mL and the concentration of UCA is 180 mg / mL, resulting in a UCA:LARG ratio of 1:1.62. The solubility limit of LARG is 182 mg / mL. The higher LARG to UCA ratio in these compositions containing rhubarb extract / rhein is believed to enhance the efficacy of rhubarb, including assisting in keeping the extract / rhein in solution.

[0248] Initial experiments were performed by varying the ratio of LARG to UCA. Figure 3 As shown in (Table 1), LARG was maintained at 293 mg / mL, and the concentration of UCA was varied up and down in 10% increments. Figure 3 The effects of these changes on the solubility of UCA and / or LARG are summarized, indicating that the ratio of UCA:LARG needs to be tightly controlled to achieve solubility of both components.

[0249] It was previously believed that LARG should be maintained in excess, particularly at a concentration above its solubility (e.g., supersaturated, such as 293 mg / mL), to maintain activity and solubility of the putative active ingredient (rhubarb extract / rhubarb). However, as described herein, reducing the LARG concentration below its solubility limit results in a much wider range of UCA:LARG ratios that can be achieved, and particularly includes, for example, ratios of 1:1 and below (i.e., where there is more UCA than LARG, by weight), with lower ratios resulting in greater therapeutic effects without the need for the use of rhubarb extract / rhubarb. For example, Figure 4 (Table 2) summarizes the solubility results, indicating that compositions with LARG concentrations below the solubility limit of LARG (eg, 182 mg / mL) and various UCA:LAGR ratios were examined.

[0250] from Figure 4 It can be clearly seen that there is a solubility "ledge" whereby UCA becomes insoluble at a UCA:LARG ratio between 1:0.67 and 1:0.64. A very narrow range is observed. Between these two points, the actual concentrations of UCA and LARG differ by 2 mg / mL (e.g., 1.9% and 2.9%, respectively).

[0251] Thus, while it is possible to formulate a wider range of UCA:LARG concentrations with LARG below its solubility limit (as opposed to above its solubility limit), only a subset of these ratios have therapeutic efficacy. A number of UCA:LARG ratios were tested against bacteria over the full solubility range (e.g., between 1:2.00 and 1:0.67). In all cases, the drug product contained UCA, LARG, and sterile water (excluding rhein and cetyl alcohol), and the total percentage of active ingredient was kept constant at 17% by adjusting the water content. Figure 5-7 and 8–11 summarize the results of these efficacy tests. For example, Figure 5 Examples of UCA and LARG compositions (without rhein or CA) applied at different UCA:LARG ratios are shown, showing that a significant antimicrobial effect occurs at a ratio of about 1:1.6 (e.g., about 1:<1.5). Figure 5 The y-axis shows the full scale (up to 1.5×10 8 CFU / mL), and Figure 6 and 7 An enlarged y-axis is provided to better show changes in efficacy, which is strongly correlated to the ratio of UCA:LARG. It is important to note that efficacy is reported as the concentration of viable bacteria (in CFU / mL) remaining after 24 hours of treatment with the drug product (in accordance with CLSI guidelines). Figure 5 , Figure 6 and Figure 7 The drug dilution in these examples is 1:16 for 17% active substance.

[0252] As mentioned, previously described drug products contain LARG above its solubility limit, and therefore contain a UCA:LARG ratio greater than 1:1 (e.g., typically greater than 1:1.6). For example, the UCA:LARG ratio in the previously described compound WT13 including rhein was 1:1.62, which is outside the effective therapeutic range (e.g., in the "shoulder" region where the therapeutic activity drops off sharply). Reducing the UCA:LARG ratio significantly improves the efficacy. For example, a UCA:LARG ratio of 1:0.67 is more than 50,000 times more effective than a ratio of 1:1.62 (which is the ratio used in previously described drug products that are supersaturated with LARG).

[0253] To further investigate the efficacy behavior at UCA:LAR ratios below about 1:1 (the case where the bacterial concentration in the upper graph is zero), the above experiment was repeated at a higher drug dilution of 1:64 at 17% active. Figure 8-11 Shown are the mean bacterial concentrations obtained from three MRSA isolates (MRSA 10, 11, and 12) as a function of the UCA:LARG ratio. Figure 8shows the full scale on both the horizontal and vertical axes, while Fig. 9 and Fig.10 shows an enlarged vertical axis, Fig.11 Magnified vertical and horizontal axes are provided. Based on the data, a UCA:LARG ratio of about 1:1 or less (e.g., l:<=l) is preferred over a ratio greater than 1:1 (e.g., l:>l). As described in more detail herein, there may be an optimal activity window for the UCA:LARG ratio, for example, typically, for each mass unit of UCA, there is a ratio of 1.5 mass units of LARG or less. More specifically, for each mass unit of UCA, there is a LARG of equal to or less than 1.4 mass units, a LARG of equal to or less than 1.3 mass units, a LARG of equal to or less than 1.2 mass units, a LARG of equal to or less than 1.1 mass units, a LARG of equal to or less than 1.0 mass units, and the like. For example, the ratio of UCA:LARG may range between about 0.65 mass units of LARG and about 1.5 mass units of LARG per mass unit of UCA (e.g., a ratio of UCA:LARG between 1:0.6 and 1:1.6).

[0254] To further support this optimal window, various compounds of UCA:LARG were tested for pH and a correlation was identified that indicated the optimal concentration relationship between UCA and LARG. Fig.12 pH is shown as a function of the UCA:LARG ratio. In this example, at ratios above about 1:0.80, the pH rises dramatically, which may be due to the relative abundance of LARG compared to UCA (LARG is highly alkaline). In some patients, high pH values ​​in pharmaceutical compositions may pose a risk of skin irritation, and the body may have difficulty providing buffering for systemic application. A more neutral pH with an optimized ratio (e.g., 1:1.0 or less, e.g., 1:<=1) may be ideal.

[0255] In the case of the previously described UCA:LARG ratio of 1:1.62, cetyl alcohol (CA) and rhein were readily maintained in solution, and the release of ammonia gas (released from LARG) was often detected. In contrast, in the optimal ratio range (e.g., between 1:0.6 and 1:1.6, such as between about 1:0.7 and 1:1.6), neither CA nor any rhein was readily incorporated or maintained in solution (and no ammonia gas release was detected).

[0256] Thus, described herein are pharmaceutically effective compositions having a UCA:LARG molar ratio ranging from about 1:0.6 to about 1:1.6. The lower end (e.g., 1:0.6) may be lower, e.g., 1:<0.65, if, for example, UCA is made soluble. These compositions may specifically exclude CA, but any other excipient or buffer may be used. For example, the range can be between about 1:0.6 (or about 1:0.65, about 1:0.66, about 1:0.67, about 1:0.68, about 1:0.69, about 1:0.7, about 1:0.72, etc.) to about 1:1.6 (for example, about 1:1.55, about 1:1.5, about 1:1.45, about 1:1.4, about 1:1.35, about 1:1.30, about 1:1.25, about 1:1.20, about 1:1.15, about 1:1.10, about 1:1.05, about 1:1.0, about 1:0.9, etc.), including any sub-ranges therein.

[0257] Also described herein are compositions of UCA and LARG replacements (by other similar chemicals in their respective families).

[0258] For example, compositions of fatty acids and amino acids within a molar ratio range of about 1:0.6 and 1:1.6 are described herein, e.g., a ratio of fatty acids: amino acids between about 1:0.6 and 1:1.6 (e.g., in some variations, between about 1:0.7 and about 1:1.6, with a molar ratio of fatty acids to amino acids of about 1:1 or about 5:4). Typically, the fatty acids can be unsaturated fatty acids (e.g., but not limited to, UCA and linoleic acid, etc.) or saturated fatty acids (e.g., but not limited to, lauric acid, caprylic acid, capric acid, etc.). The amino acids can be amino acids with charged basic side chains (e.g., but not limited to, LARG, lysine, etc.), or aromatic amino acids (e.g., but not limited to, histidine), or imino amino acids (e.g., but not limited to, proline). Surprisingly, outside these defined molar ranges, antipathogenic activity is significantly lost. For example, the range can be between about 1:0.6 (or about 1:0.62, about 1:0.63, about 1:0.64, about 1:0.65, about 1:0.66, about 1:0.67, about 1:0.68, about 1:0.69, about 1:0.7, about 1:0.72, etc.) to about 1:1.5 (or about 1:1.45, about 1:1.4, about 1:1.35, about 1:1.30, about 1:1.25, about 1:1.20, about 1:1.15, about 1:1.10, about 1:1.05, etc.), including any sub-ranges therein.

[0259] The compositions described herein may include one or more other APIs or excipients. These compositions can be used for a wide range of applications / purposes, including antibacterial, antiviral, antifungal, anticancer, and a wide range of delivery routes, including skin, systemic, oral, inhaled, intravenous and intramuscular. In particular, the compositions described herein show effective efficacy against Gram-positive and Gram-negative bacteria. The antipathogenic compounds described herein (which may also be referred to as antipathogenic agents herein) are effective against a wide variety of pathogens, including Gram-negative and Gram-positive bacteria, fungi and viruses in particular. These compositions can also be effective against other types of bacteria, including mycobacteria, and fungi.

[0260] These antipathogenic compounds can be used to treat or prevent, for example, infections in human or non-human patients, including bacterial infections. These antipathogenic compounds can be used to kill pathogen infections, stop or slow the progression of pathogen infections (or kill and / or slow or stop the growth of pathogens in or on the body or material (e.g., surface)). For example, antibacterial compositions are described herein. For example, antibacterial compositions are described herein that include a mixture of fatty acids: amino acids (e.g., UCA: LARG) between 1:0.6 and 1:1.6; other materials (excipients, diluents, or carriers) can be mixed with the mixture to form an antipathogenic compound. In some variations, the amino acid includes L-arginine and the fatty acid includes undecylenic acid.

[0261] Any therapeutic (e.g., anti-pathogenic, anti-cancer) compositions described herein can be used to treat patients, such as human or non-human patients, suffering from or at risk of infection and / or cancer by administering a therapeutically effective amount of one or more therapeutic compositions described herein comprising one or more amino acids and one or more fatty acids within the ranges. For example, methods of treating patients, such as human or non-human patients, suffering from or at risk of infection by administering a therapeutically effective amount of a composition comprising one or more fatty acids and one or more amino acids (in a molar ratio of about 1:0.6 to 1:1.6) are described herein. The range can be, for example, between about 1:0.6 (or about 1:0.66, about 1:0.67, about 1:0.68, about 1:0.69, about 1:0.7, about 1:0.72, etc.) to 1:1.45 (or about 1:1.4, about 1:1.35, about 1:1.30, about 1:1.25, about 1:1.20, about 1:1.15, about 1:1.10, about 1:1.05, about 1:1, about 1:9, etc.), including any sub-ranges therein.

[0262] Any of the anti-pathogenic compositions described herein can be part of a kit comprising one or more anti-pathogenic compositions and instructions for administration to a patient.

[0263] One or more amino acids can include, for example, one or more of the following: arginine, asparagine, aspartic acid, glutamic acid, glutamine, histidine, serine, threonine and lysine. One or more amino acids can include, for example, aliphatic amino acids, including one or more of the following: alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, isoleucine, lysine, leucine, methionine, serine, threonine and valine. In particular, one or more amino acids can include arginine, histidine and / or lysine. Fatty acid can be saturated or undersaturated (for example monounsaturated or polyunsaturated). In particular, the fatty acid may be a fatty acid having a lipid number (e.g., carbon number) between C4 and C20 or C4 and C18 (e.g., one or more of the following: butyric acid, isobutyric acid, valeric acid, 3-methylbutyric acid, hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, tridecanoic acid, tetradecanoic acid, (9Z)-hexadecenoic acid, hexadecanoic acid, heptadecanoic acid, octadecanoic acid, (9Z, 12Z)-octadec-9,12-dienoic acid, (9Z, The fatty acid may be a C4 or C18 straight chain fatty acid (e.g., butyric acid, pentanoic acid, hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, etc.). For example, the unsaturated fatty acid may be, for example, undecenoic acid (e.g., undecanoic acid). In certain variations, the fatty acids may comprise one or more C4 to C12 fatty acids (e.g., butyric acid, isobutyric acid, valeric acid, 3-methylbutyric acid, hexanoic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid), or C8 to C20 or C8 to C18.

[0264] Any of these compositions may include a cooling or heating additive, such as menthol. In addition to the mixture, the composition may also include a pharmaceutically acceptable excipient, diluent or carrier. The amount of the excipient, diluent or carrier will not change the relative proportions (percentages) of the amino acids and fatty acids.

[0265] In some variations, the topical formulation does not include any additional excipients, such as emulsifiers. In some variations, excipients, diluents or carriers can be configured for topical application. For example, excipients, diluents or carriers may include emulsifiers. Typically, excipients, diluents or carriers (including water) are inactive substances that are used as vehicles or media for drugs or other active substances. Excipients may include bulking agents, fillers, etc. Excipients can help the operation of active substances by promoting the flowability or non-stick properties of powders, improving in vitro stability (e.g., preventing denaturation or aggregation within the expected shelf life), enhancing solubility, improving absorption and / or ingestion, providing better aesthetics and / or cosmetic features, changing physical properties, etc.

[0266] Examples of excipients may include: anti-adherents (e.g., magnesium stearate, etc.); binders (e.g., sugars and their derivatives: disaccharides, sucrose, lactose; polysaccharides and their derivatives: starch, cellulose or modified cellulose, such as microcrystalline cellulose and cellulose derivatives, including cellulose ethers, such as hydroxypropyl cellulose; sugar alcohols, such as xylitol, sorbitol or mannitol; proteins: gelatin; synthetic polymers: polyvinyl pyrrolidone or PVP, polyethylene glycol or PEG, polyvinyl pyrrolidone, starch, sucrose and polyethylene glycol, methylcellulose); coating agents (e.g., cellulose ether hydroxypropyl methylcellulose, synthetic polymers, shellac, zein zein or other polysaccharides, gelatin); enteric solvents (fatty acids, waxes, shellac, plastics and plant fiber); coloring agent (titanium oxide, azo dyes, etc.); disintegrant (e.g., cross-linked polymer: cross-linked polyvinyl pyrrolidone such as cross-linked povidone, cross-linked sodium carboxymethyl cellulose or cross-linked sodium carboxymethyl cellulose, glycolate, etc.); flavoring agent (fruit extract, etc.); glidant (e.g., fumed silica, talc and magnesium carbonate, etc.); lubricant (e.g., talc or silica, and fat, such as vegetable stearin, magnesium stearate or stearic acid, etc.); preservative (e.g., antioxidant, such as vitamin A, vitamin E, vitamin C, retinyl palmitate and selenium; cysteine, methionine; citric acid, sodium citrate; parabens: methyl paraben and propyl paraben); adsorbent; sweetener (e.g. sugar); vehicles (petrolatum, dimethyl sulfoxide, mineral oil, etc.); emollients / hardeners (carnauba wax, cetyl alcohol, cetyl ester wax, emulsifying wax, aqueous lanolin, lanolin, lanolin alcohol, microcrystalline wax, paraffin, petrolatum, polyethylene glycol, stearic acid, stearyl alcohol, white wax, yellow wax, etc.); emulsifiers / emulsifying agents / solubilizers (polysorbate 20, polysorbate 80, polysorbate 60, poloxamer, emulsifying wax, sorbitan monostearate, sorbitan monooleate, sodium lauryl sulfate, propylene glycol monostearate, diethylene glycol monoethyl ether, docusate sodium, etc.); humectants (e.g. glycerin, propylene glycol, polyethylene glycol, sorbitol solution, 1,2,6-hexanetriol, etc.); thickeners / gelling agents (carbomer, methyl Cellulose, sodium carboxymethyl cellulose, carrageenan, colloidal silicon dioxide, guar gum, hydroxypropyl cellulose, hydroxypropyl methylcellulose, gelatin, polyethylene oxide, alginic acid, sodium alginate, fumed silica, etc.); preservatives (benzoic acid, propyl paraben, methyl paraben, imidurea, sorbic acid, potassium sorbate, benzalkonium chloride, phenylmercuric acetate, chlorobutanol, phenoxyethanol, etc.); penetration enhancers (propylene glycol, ethanol, isopropanol, oleic acid, polyethylene glycol, etc.); chelating agents (ethylenediaminetetraacetic acid, etc.); acidifying / alkalizing / buffering agents (citric acid, phosphoric acid, sodium hydroxide, sodium dihydrogen phosphate, trihydroxyamine, etc.); vehicles / solvents (purified water, hexylene glycol, propylene glycol, oleyl alcohol, propylene carbonate, mineral oil, etc.).The examples are potentially numerous, and different excipients may be used for different reasons and may have dual or multiple functions.

[0267] The composition may be formulated as a liquid or emulsion in a form suitable for topical administration to humans, including sprays, lotions, creams, ointments, tinctures, and the like.

[0268] Also described herein are methods of treating a patient to destroy pathogens using an anti-pathogenic agent effective against Gram-negative and Gram-positive bacteria, viruses and fungi. For example, the method may include administering to the patient a therapeutically effective amount of an anti-pathogenic agent comprising a mixture of fatty acids and amino acids as described herein, wherein the molar ratio of fatty acid:amino acid is from about 1:0.6 to about 1:1.6, and any subranges thereof.

[0269] Administration can include applying the anti-pathogenic agent to the patient's skin, the patient's wound, etc. For example, administration can include spraying the anti-pathogenic agent on the patient. Alternatively or additionally, administration can include systemically administering the anti-pathogenic agent to the patient. The compositions described herein can also be used as coatings (e.g., for medical devices, implants, etc.).

[0270] These compositions and methods of use thereof can be used to combat a variety of pathogens and / or cancers. For example, the compositions and methods of use thereof can be used to treat one or more of the following: Gram-negative bacteria, Gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli and / or viruses. This list is exemplary only and is not intended to be exhaustive. Examples of viruses can include: smallpox virus (severe variola virus and variola-like), influenza virus (type A, type B, type C and type D), rubella virus, mumps virus, rubella virus, varicella zoster virus, hepatitis A virus, hepatitis B virus, herpes simplex virus 1 and 2, polio virus, rabies rabies virus, Ebola virus, Hanta virus, human immunodeficiency virus (HIV), severe acute respiratory syndrome (SARS) coronavirus, dengue virus, Zika virus and Epstein-Barr virus,

[0271] As described above, these compositions can be used for cancer. For example, the compositions described herein can be used to treat: adenoid cystic carcinoma, adrenal cancer, amyloidosis, anal cancer, ataxia-telangiectasia, atypical nevus syndrome, basal cell carcinoma, bile duct cancer, Birt Hogg Dube syndrome, bladder cancer, bone cancer, brain tumors, breast cancer, carcinoid tumors, cervical cancer, colorectal cancer, ductal carcinoma, endometrial cancer, esophageal cancer, gastric cancer, gastrointestinal stromal tumors-GIST, HER2-positive breast cancer, islet cell tumors, juvenile polyposis syndrome, kidney cancer, laryngeal cancer, leukemia, acute lymphoblastic leukemia, acute lymphocytic (ALL) leukemia, acute myeloid AML leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, liver cancer, lobular carcinoma, lung cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, malignant glioma Cancer, melanoma, meningioma, multiple myeloma, myelodysplastic syndrome (MDS), nasopharyngeal cancer, neuroendocrine tumors, oral cancer, osteosarcoma, ovarian cancer, pancreatic cancer, pancreatic neuroendocrine tumors, parathyroid cancer, penile cancer, peritoneal cancer, Peutz-Jeghers syndrome, pituitary adenoma, polycythemia vera, prostate cancer, renal cell carcinoma, retinoblastoma, salivary gland cancer, sarcoma, skin cancer, small intestine cancer, stomach cancer, testicular cancer, thymoma, thyroid cancer, uterine (endometrial) cancer, vaginal cancer, and / or Wilms tumor. Cancer treatment may include killing or destroying cancer cells, reducing cancer proliferation, and reducing the size of tumors.

[0272] The therapeutic agent (composition) described herein may include an excipient, a diluent or a carrier, and generally does not include cetyl alcohol. Therefore, antipathogenic (e.g., antibacterial and / or antiviral and / or antifungal and / or antimicrobial) compounds and methods of use thereof are described herein. The compounds described herein and methods of preparation and use are based in part on the following discovery: a mixture of one or more amino acids and one or more fatty acids (e.g., C4-C18) forms a composition in which the ratio or percentage of each component in the mixture is in a specific range. When the components in the mixture are within the desired range, the composition exhibits a wide range of antipathogenic therapeutic properties, covering Gram-positive bacteria (including acid-resistant Gram-positive bacteria, such as mycobacteria) and Gram-negative bacteria, as well as certain pathogenic fungi and viruses. Unexpectedly, outside these limited ranges, antipathogenic activity is significantly lost, particularly for certain types of pathogens, including particularly Gram-negative bacteria.

[0273] These compositions can be used to directly treat patients (e.g., humans or non-human animals) exposed or potentially exposed to pathogens, to disinfect surfaces including medical surfaces, as coatings for medical devices or implants, or in any other application where an anti-pathogenic material would be useful. The compositions described herein also appear to have few direct negative effects (e.g., toxicity) on patients.

[0274] Unless otherwise defined, all technical and scientific terms used herein have the meanings commonly understood by those skilled in the art to which the invention belongs. The following references provide general definitions of many of the terms used in the present invention for technicians: Singleton et al., Dictionary of Microbiology and Molecular Biology (2nd edition, 1994); Cambridge Dictionary of Science and Technology (Walker ed, 1988); Glossary of Genetics, 5th edition, R. Rieger et al. (eds), Springer Verlag (1991); and Hale & Marham, Harper Collins Dictionary of Biology (1991). As used herein, unless otherwise indicated, the following terms have the meanings assigned to them. The definition of amino acids may be as described by the National Center for Biotechnology Information (NCBI).

[0275] As used herein, the following terms have the indicated meanings.

[0276] The term "acyl," as used herein, alone or in combination, refers to a carbonyl group attached to an alkenyl, alkyl, aryl, cycloalkyl, heteroaryl, heterocyclyl, or any other moiety wherein the atom attached to the carbonyl is carbon. An "acetyl" group refers to a -C(O)CH3 group.

[0277] "Alkylcarbonyl" or "alkanoyl" refers to an alkyl group attached to the parent molecular moiety through a carbonyl group. Examples of such groups include methylcarbonyl and ethylcarbonyl. Examples of acyl groups include formyl, alkanoyl and aroyl.

[0278] The term "alkenyl" as used herein, alone or in combination, refers to a straight or branched hydrocarbon group having one or more double bonds, optionally substituted, and containing 2 to 20, preferably 2 to 6 carbon atoms. Alkenyl refers to a carbon-carbon double bond system attached at two or more positions, such as vinylene [(-CH=CH-), (-C::C-)]. Examples of alkenyl groups include ethenyl, propenyl, 2-methylpropenyl, 1,4-butadienyl, and the like.

[0279] The term "alkoxy" as used herein, alone or in combination, refers to an optionally substituted alkyl ether radical, wherein the term alkyl is as defined below. Examples of alkyl ether radicals include methoxy, ethoxy, n-propoxy, isopropoxy, n-butoxy, isobutoxy, sec-butoxy, tert-butoxy, and the like.

[0280] The term "alkyl" as used herein, alone or in combination, refers to an optionally substituted straight or branched chain alkyl group containing 1 to 20 and including 20, preferably 1 to 10, and more preferably 1 to 6 carbon atoms. The alkyl group may be optionally substituted as defined herein. Examples of alkyl groups include methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, tert-butyl, pentyl, isopentyl, hexyl, octyl, nonyl, and the like.

[0281] The term "alkylamino" as used herein, alone or in combination, refers to an optionally substituted alkyl group attached to the parent molecular moiety through an amino group. The alkylamino group can be mono- or di-alkylated to form groups such as, for example, N-methylamino, N-ethylamino, N,N-dimethylamino, N,N-ethylmethylamino, and the like.

[0282] The term "alkylthio" as used herein, alone or in combination, refers to an alkylthioether (RS-) group, wherein the term alkyl is as defined above, and wherein the sulfur may be mono- or di-oxidized. Examples of alkylthioether groups include methylthio, ethylthio, n-propylthio, isopropylthio, n-butylthio, isobutylthio, sec-butylthio, tert-butylthio, methylsulfonyl, ethylsulfinyl, and the like.

[0283] The term "alkynyl" as used herein, alone or in combination, refers to a straight or branched hydrocarbon group having one or more triple bonds and containing 2 to 20, preferably 2 to 6, more preferably 2 to 4 carbon atoms. "Alkynyl" refers to a carbon-carbon triple bond attached at two positions, such as ethynyl (-C:::C-, -C≡C-). Examples of alkynyl include ethynyl, propynyl, hydroxypropynyl, butyn-1-yl, butyn-2-yl, pentyn-1-yl, 3-methylbutyn-1-yl, hexyn-2-yl, and the like.

[0284] The term "amido," as used herein, alone or in combination, refers to an amino group as described below attached to the parent molecular moiety through a carbonyl group or vice versa.

[0285] The term "amino," as used herein, alone or in combination, refers to -NRR', wherein R and R' are independently selected from hydrogen, alkyl, acyl, heteroalkyl, aryl, cycloalkyl, heteroaryl, and heterocycloalkyl, any of which can themselves be optionally substituted.

[0286] The term "aryl" as used herein, alone or in combination, refers to a carbocyclic aromatic system containing one, two or three rings, wherein such rings may be linked together or fused in a pendant manner, optionally substituted by at least one halogen, an alkyl group containing from 1 to 3 carbon atoms, an alkoxy group, an aryl group, a nitro functional group, a polyether group, a heteroaryl group, a benzoyl group, an alkyl ester group, a carboxylic acid, a hydroxy group optionally protected by an acetyl or benzoyl group, or an amino functional group optionally protected by an acetyl or benzoyl group or optionally substituted by at least one alkyl group containing from 1 to 12 carbon atoms.

[0287] The term "arylalkyl" or "aralkyl," as used herein, alone or in combination, refers to an aryl group attached to the parent molecular moiety through an alkyl group.

[0288] The term "aryloxy," as used herein, alone or in combination, refers to an aryl group attached to the parent molecular moiety through an oxygen atom.

[0289] The term "polyether group" refers to a polyether group containing 2 to 6 carbon atoms interrupted by at least one oxygen atom, for example methoxymethyl, ethoxymethyl or methoxyethoxymethyl or methoxyethyl.

[0290] The terms "benzo" and "benzene", as used herein, alone or in combination, refer to a divalent radical C6H4= derived from benzene. Examples include benzothiophene and benzimidazole.

[0291] The terms "carbamate" and "carbamoyl" as used herein, alone or in combination, refer to an ester of a carbamic acid (-NHCOO-) which may be attached to the parent molecular moiety from either the nitrogen or the acid terminus and may be optionally substituted as defined herein.

[0292] As used herein, the term "carbonyl" when alone includes formyl and in combination is a -C(O)- group.

[0293] As used herein, the term "carboxy" refers to -C(O)OH or the corresponding "carboxylate" anion, for example in a carboxylate salt. "Ocarboxy" refers to a RC(O)O- group, where R is as defined herein. "Ccarboxy" refers to a -C(O)OR group, where R is as defined herein.

[0294] The term "chemical stability" according to the present invention means that the content shows very little change relative to the initial content, ie the content change of the active ingredient at time T should not be less than 90% to more particularly 95% of the initial content at T0.

[0295] The term "cyano," as used herein, alone or in combination, refers to -CN.

[0296] The term "cycloalkyl" or alternatively "carbocycle" used herein, alone or in combination, refers to a saturated or partially saturated monocyclic, bicyclic or tricyclic alkyl group, wherein each cyclic moiety contains 3 to 12, preferably 5 to 7 carbon atoms of ring members, and which may optionally be a benzo-fused ring system, which is optionally substituted as defined herein. Examples of such cycloalkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, octahydronaphthyl, 2,3-dihydro-1H-indenyl, adamantyl, etc. "Bicyclic" and "tricyclic" used herein are intended to include fused ring systems, for example, decalin, octahydronaphthalene, and polycyclic (polycentric) saturated or partially unsaturated types. The latter type of isomer is generally exemplified by bicyclo[1,1,1]pentane, camphor, adamantane, and bicyclo[3,2,1]octane.

[0297] The term "ester" as used herein, alone or in combination, refers to a carboxyl group bridging two moieties, the moieties being attached at carbon atoms.

[0298] The term "ether," as used herein, alone or in combination, refers to an oxygen atom bridging two moieties, the moieties being attached at carbon atoms.

[0299]

[0046] The term "halo" or "halogen," as used herein, alone or in combination, refers to fluoro, chloro, bromo or iodo.

[0300] The term "haloalkyl" used herein alone or in combination refers to an alkyl group having the meaning as defined above, wherein one or more hydrogens are replaced by halogen. Specifically include monohaloalkyl, dihaloalkyl and polyhaloalkyl. For example, monohaloalkyl may have iodine, bromine, chlorine or fluorine atoms in the group. Dihalo and polyhaloalkyl may have a combination of two or more identical halogen atoms or different halogen groups. Examples of haloalkyl include fluoromethyl, difluoromethyl, trifluoromethyl, chloromethyl, dichloromethyl, trichloromethyl, pentafluoroethyl, heptafluoropropyl, difluorochloromethyl, dichlorofluoromethyl, difluoroethyl, difluoropropyl, dichloroethyl and dichloropropyl. "Haloalkylene" refers to a haloalkyl group connected at two or more positions. Examples include fluoromethylene (-CHF-), difluoromethylene (-CF2-), chloromethylene (-CHCl-) etc.

[0301] The term "heteroalkyl" as used herein, alone or in combination, refers to a stable straight or branched chain or cyclic hydrocarbon group, or a combination thereof, which is fully saturated or contains 1 to 3 degrees of unsaturation, consisting of a specified number of carbon atoms and 1-3 heteroatoms selected from O, N and S, wherein the nitrogen and sulfur atoms may be optionally oxidized, and the nitrogen heteroatom may be optionally quaternized. The heteroatoms O, N and S may be located at any internal position of the heteroalkyl group. Up to two heteroatoms may be consecutive, for example -CH2-NH-OCH3.

[0302] The term "heteroaryl" as used herein, alone or in combination, refers to a 3- to 7-membered, preferably 5- to 7-membered, unsaturated heteromonocyclic or fused polycyclic ring, wherein at least one fused ring is unsaturated, wherein at least one atom is selected from O, S and N. The term also includes fused polycyclic groups wherein heterocyclyl is fused to aryl, wherein heteroaryl is fused to other heteroaryl, or wherein heteroaryl is fused to cycloalkyl. Examples of heteroaryl groups include pyrrolyl, pyrrolinyl, imidazolyl, pyrazolyl, pyridinyl, pyrimidinyl, pyrazinyl, pyridazinyl, triazolyl, pyranyl, furanyl, thienyl, oxazolyl, isoxazolyl, oxadiazolyl, thiazolyl, thiadiazolyl, isothiazolyl, indolyl, isoindolyl, indolizinyl, benzimidazolyl, quinoline, isoquinoline, quinoxalinyl, quinazolinyl, indazolyl, benzotriazolyl, benzodioxolyl, benzopyranyl, benzoxazolyl, benzoxadiazolyl, benzothiazolyl, benzothiadiazolyl, benzofuranyl, benzothienyl, chromonyl, coumarinyl, benzopyranyl, tetrahydroquinolinyl, tetrazolopyridazinyl, tetrahydroisoquinolinyl, thienopyridinyl, furopyridinyl, pyrrolopyridinyl and the like. Examples of the tricyclic heterocyclic compound include carbazolyl, benzindolyl, o-phenanthrolinyl, dibenzofuranyl, acridinyl, phenanthridinyl, xantheneyl and the like.

[0303] The terms "heterocycloalkyl" and "heterocyclyl" as used herein, alone or in combination, each refer to a saturated, partially unsaturated or fully unsaturated monocyclic, bicyclic or tricyclic heterocyclic radical containing at least one, preferably 1 to 4, more preferably 1 to 2 heteroatoms as ring members, wherein each of said heteroatoms may be independently selected from nitrogen, oxygen and sulfur, wherein each ring preferably has 3 to 8 ring members, more preferably 3 to 7 ring members per ring, and most preferably 5 to 6 ring members per ring. "Heterocycloalkyl" and "heterocyclyl" are intended to include sulfones, sulfoxides, N-oxides of tertiary nitrogen ring members and carbocyclic-fused and benzo-fused systems; in addition, both terms also include systems wherein the heterocyclic ring is fused to an aryl or another heterocyclic radical as defined herein. Examples of heterocyclic groups of the present invention include propidinyl, azetidinyl, 1,3-benzodioxolyl, dihydroisoindolyl, dihydroisoquinolinyl, dihydrocinnolinyl, dihydrobenzodioxinyl, dihydro[1,3]oxazolo[4,5-b]pyridinyl, benzothiazolyl, dihydroindolyl, dihydropyridinyl, 1,3-dioxanyl, 1,4-dioxanyl, 1,3-dioxolanyl, isoindolyl, morpholinyl, piperazinyl, pyrrolidinyl, tetrahydropyridinyl, piperidinyl, thiomorpholinyl, and the like. Unless specifically prohibited, the heterocyclic group may be optionally substituted.

[0304] The term "hydroxy," as used herein, alone or in combination, refers to -OH.

[0305] The phrase "in the backbone" refers to the longest continuous or adjacent chain of carbon atoms starting from the point of attachment of a group to the compound of the present invention.

[0306] The phrase "linear chain of atoms" refers to the longest straight chain of atoms independently selected from carbon, nitrogen, oxygen and sulfur.

[0307] The term "lower" as used herein, alone or in combination, refers to containing 1 to (and including) 6 carbon atoms.

[0308] As used herein, the term "negatively charged ion" refers to any negatively charged ion or molecule, which is inorganic (eg, Cl-, Br-, I-) or organic (eg, TsO- (ie, tosylate)).

[0309] The term "nitro," as used herein, alone or in combination, refers to -NO2.

[0310] The term "perhaloalkyl," as used herein, alone or in combination, refers to an alkyl group in which all of the hydrogen atoms are replaced by halogen atoms.

[0311] Any definition herein may be used in conjunction with any other definition to describe a composite structural group. By convention, the trailing element of any such definition is the element attached to the parent moiety. For example, the composite group alkylamido will represent an alkyl group attached to the parent molecule via an amino group, and the term alkoxyalkyl will represent an alkoxy group attached to the parent molecule via an alkyl group.

[0312] When a group is defined as "empty", it means that the group does not exist.

[0313] The term "optionally substituted" means that the preceding group may be substituted or unsubstituted. When substituted, the substituents of the "optionally substituted" group may include, but are not limited to, one or more substituents independently selected from the following groups or specific designated groups, alone or in combination: lower alkyl, lower alkenyl, lower alkynyl, lower alkanoyl, lower heteroalkyl, lower heterocycloalkyl, lower haloalkyl, lower haloalkenyl, lower haloalkynyl, lower perhaloalkyl, lower perhaloalkoxy, lower cycloalkyl, phenyl, aryl, aryloxy, lower alkoxy, lower haloalkoxy, oxo, lower acyloxy, carbonyl , carboxyl, lower alkyl carbonyl, lower carboxylic acid ester, lower carboxylic acid amide, cyano, hydrogen, halogen, hydroxyl, amino, lower alkyl amino, aryl amino, amide, nitro, thiol, lower alkylthio, arylthio, lower alkyl sulfinyl, lower alkyl sulfonyl, aryl sulfinyl, aryl sulfonyl, arylthio, sulfonate, sulfonic acid, trisubstituted silyl, N3, SH, SCH3, C(O)CH3, CO2CH3, CO2H, pyridyl, thiophene, furyl, lower carbamate and lower urea. Two substituents can be linked together to form a fused five-, six- or seven-membered carbocyclic or heterocyclic ring consisting of zero to three heteroatoms, for example, to form methylenedioxy or ethylenedioxy. Optionally substituted groups can be unsubstituted (e.g., -CH2CH3), fully substituted (e.g., -CF2CF3), monosubstituted (e.g., -CH2CH2F), or any level of substitution between fully substituted and monosubstituted (e.g., -CH2CF3). Where substituents are listed without qualification as to substitution, both substituted and unsubstituted forms are contemplated. When a substituent is qualified as "substituted", substituted forms are specifically intended. Additionally, different sets of optional substituents for a particular moiety may be defined as desired; in these cases, the optional substitution is as defined, typically immediately following the phrase "optionally substituted with...".

[0314] Asymmetric centers are present in the compounds of the present invention. These centers are designated by the symbols "R" or "S", depending on the configuration of the substituents around the chiral carbon atom. It should be understood that the present invention encompasses all stereochemical isomeric forms, including diastereoisomers, enantiomeric and epimeric forms, as well as d-isomers and l-isomers, and mixtures thereof. Individual stereoisomers of a compound can be synthesized from commercially available starting materials containing a chiral center, or by preparing a mixture of enantiomeric products, followed by separation (e.g., conversion into a mixture of diastereoisomers), followed by separation or recrystallization, chromatography techniques, methods for direct separation of enantiomers on a chiral chromatographic column, or any other suitable method known in the art. Starting compounds with specific stereochemistry can be commercially available, or can be prepared and resolved by techniques known in the art. In addition, the compounds of the present invention can exist in the form of geometric isomers. The present invention includes all cis, trans, syn, anti, entgegen (E) and zusammen (Z) isomers, and appropriate mixtures thereof. In addition, the compounds may exist in the form of tautomers; the present invention provides all tautomers. In addition, the compounds of the present invention may exist in unsolvated and solvated forms with pharmaceutically acceptable solvents such as water, ethanol, etc. In general, for the purposes of the present invention, the solvated forms are considered equivalent to the unsolvated forms.

[0315] Optical isomers are compounds that have the same molecular formula but differ in the direction they rotate plane polarized light. There are two types of optical isomers. The first type of optical isomers are compounds that are mirror images of each other but are not superimposable on each other. These isomers are called "enantiomers". The second type of optical isomers are molecules that are not mirror images, but each molecule rotates plane polarized light and is considered optically active. Such molecules are called "diastereomers". Diastereomers differ not only in the way they rotate plane polarized light, but also in their physical properties. The term "optical isomer" more specifically includes enantiomers and diastereomers in pure form or in the form of a mixture.

[0316] The term "bond" refers to a covalent connection between two atoms or two moieties when the atoms connected by the bond are considered to be part of a larger substructure. Unless otherwise specified, a bond can be a single, double, or triple bond. A dashed line between two atoms in a molecular diagram indicates that an additional bond may or may not be present at that position.

[0317] The term "combination therapy" refers to the administration of two or more therapeutic agents to treat the therapeutic conditions or disorders described herein. Such administration includes co-administration of these therapeutic agents in a substantially simultaneous manner, such as in a single capsule with a fixed ratio of active ingredients or in multiple separate capsules of each active ingredient. In addition, such administration also includes the use of each type of therapeutic agent in a sequential manner. In either case, the treatment regimen will provide a beneficial effect of the drug combination in treating the conditions or disorders described herein.

[0318] As used herein, the term "imaging agent" refers to any portion of a compound of the invention that can be used to detect, trace or visualize the compound of the invention when coupled to the compound of the invention. Imaging agents include, for example, enzymes, fluorescent labels (e.g., fluorescein), luminescent labels, bioluminescent labels, magnetic labels, metal particles (e.g., gold particles), nanoparticles, antibodies or fragments thereof (e.g., Fab, Fab' or F(ab')2 molecules) and biotin. Imaging agents can be coupled to the compound of the invention by, for example, covalent bonds, ionic bonds, van der Waals interactions or hydrophobic bonds. The imaging agent of the invention can be a radioactive label coupled to the compound of the invention, or a radioactive isotope incorporated into the chemical structure of the compound of the invention. Methods for detecting such imaging agents include, but are not limited to, positron emission tomography (PET), X-ray computed tomography (CT) and magnetic resonance imaging (MRI).

[0319] The phrase "therapeutically effective" is intended to qualify the amount of active ingredient used to treat a disease or condition. This amount will achieve the goal of reducing or eliminating the disease or condition.

[0320] The term "therapeutically acceptable" refers to those compounds (or their salts, esters, prodrugs, tautomers, zwitterionic forms, etc.) that are suitable for contact with the tissues of patients without excessive toxicity, irritation and allergy, commensurate with a reasonable benefit / risk ratio, and effective for their intended use.

[0321] As used herein, reference to "treatment" of a patient is intended to include prevention. The term "patient" refers to both mammals and non-mammals. Mammals refer to any member of the mammal class, including but not limited to humans; non-human primates, such as chimpanzees and other apes and monkey species; livestock, such as cattle, horses, sheep, goats and pigs; domestic animals, such as rabbits, dogs and cats; laboratory animals, including rodents, such as rats, mice and guinea pigs; and the like. Examples of non-mammals include, but are not limited to, birds, and the like. The term "patient" does not specify a particular age or sex.

[0322] The term "prodrug" refers to a compound that is made more active in vivo. As described in "Hydrolysis in Drug and Prodrug Metabolism: Chemistry, Biochemistry and Enzymology", Testa, Bernard and Wiley-VHCA, Zurich, Switzerland, 2003, certain compounds of the present invention may also exist as prodrugs. Prodrugs of compounds described herein are structurally modified compound forms that are susceptible to chemical changes under physiological conditions to provide the compound. In addition, prodrugs can be converted into compounds by chemical or biochemical methods in an ex vivo environment. For example, when a prodrug is placed in a transdermal patch reservoir together with a suitable enzyme or chemical reagent, the prodrug can be slowly converted into a compound. Prodrugs are often useful because, in some cases, they may be easier to administer than a compound or parent drug. For example, a prodrug may be more bioavailable by oral administration, while the parent drug is not. Compared with the parent drug, the prodrug may also have improved solubility in a pharmaceutical composition. A wide variety of prodrug derivatives are known in the art, such as those that rely on hydrolytic cleavage or oxidative activation of the prodrug. An example (but not limited to) of a prodrug is a compound that is administered in an ester form (the "prodrug") and then metabolically hydrolyzed to the carboxylic acid (the active entity). Additional examples include peptidyl derivatives of the compound.

[0323] The compounds of the present invention may exist as therapeutically acceptable salts. The present invention includes the compounds listed above in the form of salts, particularly acid addition salts. Suitable salts include salts formed with organic and inorganic acids. Such acid addition salts are generally pharmaceutically acceptable. However, salts that are not pharmaceutically acceptable salts may be used in the preparation and purification of the compounds in question. Base addition salts may also be formed and are pharmaceutically acceptable. For a more complete discussion of the preparation and selection of salts, see Stahl, P. Heinrich, Pharmaceutical Salts: Properties, Selection and Use, Wiley-VCHA, Zurich, Switzerland (2002).

[0324] As used herein, the term "therapeutically acceptable salt" means a salt or zwitterionic form of a compound of the invention that is water or oil soluble or dispersible and as defined herein is therapeutically acceptable. Salts can be prepared during the final separation and purification of the compound, or separately prepared by reacting a suitable compound in free base form with a suitable acid. Representative acid addition salts include acetate, adipate, alginate, L-ascorbate, aspartate, benzoate, benzene-sulfonate (benzenesulfonate), bisulfate, butyrate, camphorate, camphorsulfonate, citrate, digluconate, formate, fumarate, gentisate, glutamate, glycerophosphate, glycolate, hemihydrate sulfate, heptanoate, hexanoate, hippurate, hydrochloride, hydrobromide, hydroiodide, 2-hydroxyethanesulfonate (isothiocyanate), lactate, Maleate, malonate, DL-mandelate, isophthalide, methanesulfonate, naphthylsulfonate, nicotinate, 2-naphthalenesulfonate, oxalate, pamoate, pectinate, persulfate, 3-phenylpropionate, phosphonate, picrate, pivalate, propionate, pyroglutamate, succinate, sulfonate, tartrate, L-tartrate, trichloroacetate, trifluoroacetate, phosphate, glutamate, bicarbonate, p-toluenesulfonate (p-toluenesulfonate) and undecanoate. In addition, the basic groups in the compounds of the present invention can be quaternized with the following: methyl, ethyl, propyl and butyl chlorides, bromides and iodides; dimethyl, diethyl, dibutyl and diamyl sulfates; decyl, lauryl, myristyl and steryl chlorides, bromides and iodides; and benzyl and phenethyl bromides. Examples of acids that can be used to form therapeutically acceptable addition salts include inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid and phosphoric acid, and organic acids such as oxalic acid, maleic acid, succinic acid and citric acid. Salts can also be formed by the coordination of compounds with alkali metal or alkaline earth metal ions. Therefore, the present invention contemplates sodium salts, potassium salts, magnesium salts and calcium salts of compounds of the present invention, etc.

[0325] Composition

[0326] The compositions and therapies described herein can be used to effectively kill and / or inhibit pathogens and / or cancer. Specifically, the composition can kill or inhibit bacterial growth, and can simultaneously promote healing, including (but not limited to) wound healing. The composition described herein (antipathogenic composition) can include a therapeutically effective amount of one or more amino acids and one or more fatty acids (e.g., UCA and LARG, decanoic acid and LARG, etc.). The combination of these compounds within a specified ratio range can exert a synergistic, rather than cumulative, biological mechanism of action, which can prevent infection and promote healing by, for example, inhibiting pathogen growth and / or enhancing pathogen death (elimination). In addition, the compositions described herein can bring greater therapeutic benefits to the treated patient (e.g., human) compared to the sequential administration of the constituent compounds. In addition, it has been demonstrated that these compositions have anti-cancer therapeutic effects, including but not limited to inhibiting the growth and / or spread of cancer cells (including tumors).

[0327] Therefore, the compositions and therapies described herein can be used to treat symptoms, disorders and diseases caused by pathogenic infections and / or cancers in patients (e.g., humans). Also described herein are methods for preparing drugs and drugs obtained therefrom. Methods and formulations for preparing the compositions described herein are disclosed.

[0328] Standard (i.e., canonical) or non-standard (i.e., non-canonical) amino acids (D or L isomers), particularly amino acids with charged basic side chains, in combination with unsaturated or saturated fatty acids (e.g., C4-C18 fatty acids, C8-C18, C4-C20, C4-C18, etc.) can be used to form a mixture that produces a rapid and effective bactericidal effect on Gram-positive and Gram-negative bacteria. The ratio of these mixture components (e.g., amino acids and fatty acids) in the mixture can be optimized for antipathogenic effect.

[0329] As used herein, anti-pathogenic materials include antimicrobial (bactericidal) compositions. Bactericides can be considered chemical entities that produce a bacterial kill rate that is greater than the bacterial growth rate over time, while bacteriostatics can be considered chemical entities that inhibit bacterial reproduction but do not directly kill bacteria.

[0330] Examples of unsaturated fatty acids (in addition to those described above) may include, but are not limited to, crotonic acid (CAS Registry No. 107-93-7), myristoleic acid (CAS Registry No. 544-64-9), palmitoleic acid (CAS Registry No. 373-49-9), sapienic acid (CAS Registry No. 373-49-9), acid)(CAS Reg. No. 17004-51-2), elaidic acid (CAS Reg. No. 112-79-8), vaccenic acid (CAS Reg. No. 506-17-2), gadoleic acid (CAS Reg. No. 29204-02-2), eicosenoic acid (CAS Reg. No. 5561-99-9), erucic acid (CAS Reg. No. 112-86-7), nervonic acid (CAS Reg. No. 506-37-6), linoleic acid (CAS Reg. No. 60-33-3, 463-40-1), pinolenic acid (CAS Reg. No. 16833-54-8), eleostearic acid (PubChem #5281115), mead acid (CAS Reg. No. 20590-32-3), dihomo-γ-linolenic acid (CAS Reg. No. 1783-84-2), eicosatriene The present invention relates to the following compounds: 1) oleic acid (CAS Reg. No. 17046-59-2), octadecatetraenoic acid (CAS Reg. No. 20290-75-9), arachidonic acid (CAS Reg. No. 506-32-1), eicosatetraenoic acid (PubChem #231), adrenic acid (CAS Reg. No. 28874-58-0), bosseopentaenoic acid (CAS Reg. No. 133205-91-1), eicosapentaenoic acid (CAS Reg. No. 10417-94-4), ozubondoacid (CAS Reg. No. 25182-74-5), tetracosanolpentaenoic acid, docosahexaenoic acid (CAS Reg. No. 6217-54-5) and oleic acid (CAS Reg. No. 112-80-1).

[0331] Examples of saturated fatty acids include (in addition to those described above), but are not limited to, propionic acid (CAS Reg. No. 79-09-04), butyric acid (CAS Reg. No. 107-92-6), valeric acid (CAS Reg. No. 109-52-4), hexanoic acid (CAS Reg. No. 142-62-1), heptanoic acid (CAS Reg. No. 111-14-8), octanoic acid (CAS Reg. No. 124-07-2), nonanoic acid (CAS Reg. No. 112-05-0), decanoic acid (CAS Reg. No. 334-48-7), caprylic acid (CAS Reg. No. 124-07-2), nonanoic acid (CAS Reg. No. 112-05-0), capric acid (CAS Reg. No. 334-48-7). -5), undecanoic acid (CAS Reg. No. 112-37-8), dodecanoic acid (CAS Reg. No. 143-07-7), tridecanoic acid (CAS Reg. No. 638-53-9), tetradecanoic acid (CAS Reg. No. 544-63-8), pentadecanoic acid (CAS Reg. No. 1002-84-2), hexadecanoic acid (CAS Reg. No. 57-10-3), heptadecanoic acid (CAS Reg. No. 506-12-7), octadecanoic acid (CAS Reg. No. 57-11-4), nonadecanoic acid (CAS Reg. No. 646-30-0), eicosanoic acid (CAS Reg. No. 506-30-9), heneicosanoic acid (CAS Reg. No. 2363-71-5), docosanoic acid (CAS Reg. No. 112-85-6), tricosanoic acid (PubChem #17085), tetracosanoic acid (CAS Reg. No. 557-59-5), pentacosanoic acid (PubChem #10468), hexacosanoic acid (CAS Reg. No. 506-46-7), heptacosanoic acid ( No. 23524), octacosanoic acid (CAS Reg. No. 506-48-9), nonacosanoic acid (PubChem #20245), triacontanoic acid (CAS Reg. No. 506-50-3), undecanoic acid (CAS Reg. No. 28232-01-8), dotriacontanoic acid (CAS Reg. No. 3625-52-3), tritriacontanoic acid (CAS Reg. No. 38232-03-0), tetratriacontanoic acid (CAS Reg. No. 506-50-3), pentatriacontanoic acid (PubChem #5282595), hexatriacontanoic acid (CAS Reg. No. 4299-38-1) and heptriacontanoic acid (PubChem #5282597).

[0332] As mentioned above, in some variations, the specific fatty acid that this paper pays attention to is a C11 fatty acid, such as undecylenic acid. The C11 fatty acid includes a molecule containing eleven carbons similar to undecylenic acid, and can be combined with other parts. Other fatty acids of interest can include C4-C20 fatty acids, especially include straight-chain C4-C20 fatty acids, such as (but not limited to): capric acid and caprylic acid (e.g., C4-C18, C8-C18, C8-C20, etc.).

[0333] Standard (canonical) or non-standard (non-canonical) amino acids are defined as organic compounds containing amine (-NH2) and carboxyl (-COOH) functional groups and side chains (R groups) specific to each amino acid. This includes proteinogenic and non-proteinogenic amino acids. This includes D and L isomers (enantiomers). The following amino acids include, but are not limited to, D and L isomers: alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, selenocysteine ​​and pyrrolysine. Amino acids with charged basic side chains are of particular interest in this article. Aliphatic amino acids include: alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, isoleucine, lysine, leucine, methionine, serine, threonine and valine. Non-aliphatic amino acids may include: aromatic amino acids (eg, phenylalanine, histidine, tyrosine, tryptophan) and imino amino acids (eg, proline).

[0334] Base addition salts can be prepared during the final isolation and purification of the compounds by reacting the carboxyl group with a suitable base such as a hydroxide, carbonate or bicarbonate of a metal cation, or with ammonia or an organic primary, secondary, or tertiary amine. The cations of therapeutically acceptable salts include lithium, sodium, potassium, calcium, magnesium and aluminum, and non-toxic quaternary ammonium cations such as ammonium, tetramethylammonium, tetraethylammonium, methylamine, dimethylamine, trimethylamine, triethylamine, diethylamine, ethylamine, tributylamine, pyridine, N,N-dimethylaniline, N-methylpiperidine, N-methylmorpholine, dicyclohexylamine, procaine, dibenzylamine, N,N-dibenzylphenethylamine, 1-diphenylhydroxymethylamine and N,N′-dibenzylethylenediamine. Other representative organic amines useful for forming base addition salts include ethylenediamine, ethanolamine, diethanolamine, piperidine and piperazine.

[0335] Salts of compounds can be prepared by reacting the free base form of the appropriate compound with a suitable acid. The novel compounds described herein can be prepared in the form of pharmaceutically acceptable salts, which can be prepared from non-toxic inorganic or organic bases, including but not limited to aluminum, ammonium, calcium, copper, iron, ferrous, lithium, magnesium, manganese salts, manganese, potassium, sodium, zinc, etc. Salts derived from pharmaceutically acceptable organic non-toxic bases include salts of primary, secondary, and tertiary amines, substituted amines (including naturally occurring substituted amines), cyclic amines and basic ion exchange resins, such as arginine, betaine, caffeine, choline, ethylamine, 2-diethylaminoethanol, 1,2-dimethylaminoethanol, ethanolamine, ethylenediamine, N-ethylmorpholine, N-ethylpiperidine, glucamine, glucosamine, histidine, hydroxylamine, isopropylamine, lysine, methylglucamine, morpholine, piperazine, piperidine, polyamine resins, procaine, purines, theobromine, triethylamine, trimethylamine, trishydroxymethylaminomethane, tripropylamine and tromethamine.

[0336] If the compound of the present invention is basic, salts may be prepared in the form of pharmaceutically acceptable salts prepared from non-toxic inorganic or organic acids including, but not limited to, hydrochloric acid, hydrobromic acid, phosphoric acid, sulfuric acid, tartaric acid, citric acid, acetic acid, fumaric acid, alkylsulfonic acid, naphthalenesulfonic acid, p-toluenesulfonic acid, camphoric acid, benzenesulfonic acid, benzoic acid, camphorsulfonic acid, citric acid, ethanesulfonic acid, gluconic acid, glutamic acid, hydroxyethyl, lactic acid, maleic acid, malic acid, mandelic acid, methanesulfonic acid, mucic acid, nitric acid, pamoic acid, pantothenic acid, phosphoric acid and succinic acid.

[0337] Although the compounds of the present invention can be administered as raw chemicals, they can also be presented as pharmaceutical preparations. Therefore, the present invention provides pharmaceutical preparations comprising a compound or a pharmaceutically acceptable salt, ester, prodrug or solvate thereof, and one or more pharmaceutically acceptable carriers thereof and optionally one or more other therapeutic ingredients. The carrier must be "acceptable" in the sense of being compatible with the other ingredients of the formulation and harmless to the recipient. The appropriate formulation depends on the chosen route of administration. Any well-known techniques, carriers and excipients can be used, as appropriate and as understood in the art; for example, as described in Remington's Pharmaceutical Sciences. The pharmaceutical compositions of the present invention can be manufactured in a manner known per se, for example, by conventional mixing, dissolving, granulating, making dragees, leaching, emulsifying, encapsulating, embedding or compression methods.

[0338] Although the most suitable route of administration may depend on, for example, the condition and illness of the recipient, the preparation may be suitable for oral, parenteral (including subcutaneous, intradermal, intramuscular, intravenous, intraarticular and intramedullary), intraperitoneal, transmucosal, transdermal, rectal and topical (including skin, buccal, sublingual and intraocular) administration. The preparation may be conveniently present in unit dosage form and may be prepared by any method known in the pharmaceutical field. All methods include the step of combining the compound of the present invention or its pharmaceutically acceptable salt, ester, prodrug or solvate ("active ingredient") with a carrier constituting one or more auxiliary ingredients. Typically, the preparation is prepared as follows: by uniformly and closely combining the active ingredient with a liquid carrier or a finely divided solid carrier or both, and then, if necessary, the product is formed into a desired preparation.

[0339] Formulations of the invention suitable for oral administration may be presented as discrete units such as capsules, cachets or tablets, each containing a predetermined amount of the active ingredient; as a powder or granules; as a solution or suspension in an aqueous liquid or a non-aqueous liquid; or as an oil-in-water liquid emulsion or a water-in-oil liquid emulsion. The active ingredient may also be presented as a bolus, suppository or patch.

[0340] Pharmaceutical preparations that can be used orally include tablets, push-fit capsules made of gelatin, and sealed soft capsules made of gelatin and plasticizers such as glycerol or sorbitol. Tablets can be made by compression or molding, optionally with one or more auxiliary ingredients. Compressed tablets can be prepared by compressing the active ingredient in a free-flowing form such as powder or granules in a suitable machine, optionally mixed with a binder, an inert diluent or lubricant, a surfactant or a dispersant. Molded tablets can be prepared by molding a mixture of powdered compounds moistened with an inert liquid diluent in a suitable machine. Tablets can be optionally coated or scored and can be formulated to provide a slow or controlled release of the active ingredient therein. All oral administration preparations should be used in a dose suitable for such administration. Push-fit capsules can contain active ingredients mixed with fillers such as lactose, binders such as starches and / or lubricants such as talc or magnesium stearate and optional stabilizers. In soft capsules, the active compound can be dissolved or suspended in a suitable liquid, such as a fatty oil, liquid paraffin or a liquid polyethylene glycol. In addition, stabilizers may be added. The core of the dragee has a suitable coating. For this purpose, a concentrated sugar solution may be used, which may optionally contain gum arabic, talc, polyvinyl pyrrolidone, carbomer gel, polyethylene glycol and / or titanium dioxide, lacquer solution and a suitable organic solvent or solvent mixture. Dyes or pigments may be added to the tablet or dragee coating to identify or characterize different combinations of active compound dosages.

[0341] The compounds described herein (e.g., antipathogenic and / or anticancer compounds) can be formulated for parenteral administration by injection (e.g., by push injection or continuous infusion). Injectable formulations can be in unit dosage form, such as in ampoules or in multi-dose containers, with the addition of preservatives. The composition can take the form of an emulsion such as a suspension, solution, or oily or aqueous medium, and may contain a preparatant such as a suspending agent, a stabilizer, and / or a dispersant. The formulation can be present in unit dose or multi-dose containers, such as sealed ampoules and vials, and can be stored in powder form or in freeze-dried (lyophilized) conditions that require only the immediate addition of a sterile liquid (e.g., saline or sterile pyrogen-free water) carrier prior to use. Extemporaneous injection solutions and suspensions can be prepared from sterile powders, granules, and tablets of the aforementioned types.

[0342] Preparations for parenteral administration include aqueous and non-aqueous (oily) sterile injection solutions of the active compound, which may contain antioxidants, buffers, bacteriostats, and solutes that make the preparation isotonic with the blood of the intended recipient; aqueous and non-aqueous sterile suspensions, which may include suspending agents and thickening agents. Suitable lipophilic solvents or vehicles include fatty oils, such as sesame oil, or synthetic fatty acid esters, such as ethyl oleate or triglycerides, or liposomes. Aqueous injection suspensions may include substances that increase the viscosity of the suspension, such as sodium carboxymethylcellulose, sorbitol, or dextran. Optionally, the suspension may also include a suitable stabilizer or an agent that increases the solubility of the compound to allow the preparation of a highly concentrated solution.

[0343] In addition to the compounds described herein (e.g., antipathogenic compounds), the compounds of the invention can also be formulated as depot preparations. Such long-acting preparations can be administered by implantation (e.g., subcutaneous or intramuscular) or by intramuscular injection. Thus, for example, the compounds can be formulated with suitable polymeric or hydrophobic materials (e.g., as an emulsion in an acceptable oil) or ion exchange resins, or as sparingly soluble derivatives, e.g., as sparingly soluble salts.

[0344] For oral or sublingual administration, the compounds described herein (e.g., antipathogenic compounds) can take the form of tablets, lozenges, pastilles or gels formulated in a conventional manner. Such compositions may contain active ingredients based on flavoring agents, such as sucrose and gum arabic or tragacanth.

[0345] The compounds described herein (eg, antipathogenic compounds) can also be formulated in rectal compositions such as suppositories or retention enemas, eg, containing conventional suppository bases such as cocoa butter, polyethylene glycol, or other glycerides.

[0346] The compounds described herein (e.g., antipathogenic compounds) can be administered topically, i.e., by non-systemic administration. This includes external application of the compound to the epidermis or oral cavity, or dropping the compound into the ear, eye, and nose, so that the compound does not significantly enter the bloodstream. In contrast, systemic administration refers to oral, intravenous, intraperitoneal, and intramuscular administration.

[0347] Preparations suitable for topical administration include solid, liquid or semi-liquid preparations suitable for penetrating the skin to the site of infection, such as gels, liniments, lotions, creams, ointments or patches, and drops suitable for application to the eyes, ears or nose. In some examples, for topical administration, the active ingredient may account for 0.001% to 40% w / w of the preparation weight, such as 1% to 5% (e.g., 0.001% to 35%, 0.002% to 30%, 0.01% to 25%, 0.05% to 20%, 0.1% to 15%, 0.1% to 12.5%, 0.5% to 10%, 0.5% to 8%, 1% to 7%, 1% to 6%, 1% to 5%, etc.). However, it may also comprise greater than 10% w / w (e.g., less than or equal to 20%, less than or equal to 25%, less than or equal to 30%, less than or equal to 35%, less than or equal to 40%, less than or equal to 45%, less than or equal to 50%, etc., and / or in certain variations greater than 0.001%, greater than 0.01%, greater than 0.1%, greater than 1%, etc.).

[0348] By topical route, the pharmaceutical compounds described herein (e.g., antipathogenic compounds) can be in the form of a liquid or semi-liquid, such as an ointment, or in the form of a solid, such as a powder. It can also be in the form of a suspension, such as polymer microspheres, or polymer patches and hydrogels that allow controlled release. The topical composition can be in anhydrous form, aqueous form, or emulsion form. Relative to the total weight of the composition, the compound can be used topically at a concentration of 0.001% to 10% by weight (e.g., 0.01% to 1% by weight). In some variations, the compound can be used by weight at a concentration greater than 10% (e.g., less than or equal to 20%, less than or equal to 25%, less than or equal to 30%, less than or equal to 35%, less than or equal to 40%, less than or equal to 45%, less than or equal to 50%, etc.).

[0349] For administration by inhalation, the compounds described herein (e.g., antipathogenic compounds) can be conveniently delivered from an insufflator, a nebulizer pressurized package, or other convenient means of delivering an aerosol. The pressurized package may contain a suitable propellant, such as dichlorodifluoromethane, trichlorofluoromethane, dichlorotetrafluoroethane, carbon dioxide or other suitable gas. In the case of a pressurized aerosol, the unit dose can be determined by providing a valve to deliver a metered amount. Alternatively, for administration by inhalation or insufflation, the compounds of the invention may take the form of a dry powder composition, such as a mixture of the compound and a suitable powder base such as lactose or starch. The powder composition may be present in unit dosage form, for example, in a capsule, cartridge, gelatin or blister pack, from which the powder can be administered with the aid of an inhaler or insufflator. Other potential applications may include industrial applications, such as "microbicides", for use in agriculture, food production, and the like.

[0350] Preferred unit dosage formulations include those containing an effective dose, as hereinbelow recited, or an appropriate fraction thereof, of the active ingredient.

[0351] It should be understood that in addition to the ingredients particularly mentioned above the formulations of this invention may include other agents conventional in the art having regard to the type of formulation in question, for example those suitable for oral administration may include flavoring agents.

[0352] The compounds described herein (e.g., antipathogenic compounds) can be administered orally or by injection at a certain dose. Tablets or other presentation forms provided in discrete units can conveniently contain a certain amount of the compound of the present invention, which is effective at the dose or multiples thereof. For example, the compounds described herein (e.g., antipathogenic compounds) can be administered at a daily dose of about 0.001 mg / kg to 100 mg / kg body weight, taken in 1-3 doses. In some variations, the compound can be administered systemically, typically at a concentration between 0.001% and 10% by weight, preferably between 0.01% and 1% by weight, relative to the weight of the composition.

[0353] Mixtures of amino acids and fatty acids (e.g., L-Arg and UCA, L-Arg and capric acid, etc.) may be considered collectively or separately as the active ingredient (or if separately, multiple active ingredients) which may be combined with a carrier material to produce a single dosage form which varies depending upon the host being treated and the particular mode of administration.

[0354] The compounds described herein (e.g., antipathogenic compounds) can be administered in various ways, such as orally, topically or by injection. The exact amount of the compound administered to the patient may be the responsibility of the attending physician. The specific dosage level of any particular patient may depend on a variety of factors, including the activity of the specific compound used, age, body weight, overall health, sex, diet, administration time, administration route, excretion rate, drug combination, the exact disorder to be treated, and the severity of the indication or condition to be treated. Similarly, the route of administration may vary depending on the condition and its severity.

[0355] In some cases, it may be appropriate to administer at least one compound described herein (e.g., an antipathogenic compound) or a pharmaceutically acceptable salt, ester, or prodrug thereof in combination with another therapeutic agent. By way of example only, if one of the side effects experienced by a patient when receiving one of the compounds herein is hypertension, it may be appropriate to administer an antihypertensive agent in combination with the initial therapeutic agent. Alternatively, by way of example only, the therapeutic effect of one of the compounds described herein may be enhanced by administering an adjuvant (i.e., the adjuvant itself has only minimal therapeutic benefit, but after being combined with another therapeutic agent, the overall therapeutic benefit to the patient is enhanced). Alternatively, by way of example only, the benefit experienced by the patient may be increased by administering one of the compounds described herein together with another therapeutic agent (also including a treatment regimen) that also has a therapeutic benefit. By way of example only, in pain treatment involving the administration of one of the compounds described herein, the therapeutic benefit may also be increased by providing the patient with another pain therapeutic agent. In any case, regardless of the disease, disorder, or condition being treated, the overall benefit experienced by the patient may be simply the sum of the two therapeutic agents, or the patient may experience a synergistic benefit.

[0356] Specific non-limiting examples of possible combinations with the compounds described herein can include using the compounds with inert or active compounds, or other drugs, including wetting agents, flavor enhancers, preservatives, stabilizers, humidity regulators, pH regulators, osmotic pressure regulators, emulsifiers, UV-A and UV-B screening agents, antioxidants, depigmenting agents (such as hydroquinone or kojic acid), emollients, humectants (such as glycerol), PEG 400 or urea, antiseborrheic or antiacne agents (e.g. S-carboxymethylcysteine, S-benzylcysteamine, their salts or their derivatives) or benzoyl peroxide, antibiotics such as erythromycin and tetracycline, chemotherapeutic agents such as paclitaxel, antifungal agents such as ketoconazole, agents that promote hair regrowth, for example, minoxidil (2,4-diamino-6-piperidinopyrimidine 3-oxide), nonsteroidal anti-inflammatory drugs, carotenoids, especially p-carotene, antipsoriatic drugs such as anthralin and its derivatives, eicosa-5,8,11,14-tetraynoic acid and eicosa-5,8,11-triynoic acid and their esters and amides, Vitamin A, such as RAR or RXR receptor ligands, which are natural or synthetic, corticosteroids or estrogens, α-hydroxy acids and α-keto acids or derivatives thereof, such as lactic acid, malic acid, citric acid, and salts, amides or esters thereof, or parahydroxy acids or derivatives thereof (such as salicylic acid and salts, amides or esters thereof), ion channel blockers (such as potassium channel blockers), or more particularly for pharmaceutical compositions, in combination with drugs known to interfere with the immune system and anticonvulsants, including but not limited to topiramate, topiramate analogs, carbamazepine, valproic acid, lamotrigine, gabapentin, phenytoin, etc. and mixtures thereof or pharmaceutically acceptable salts. Those skilled in the art will carefully select other compounds to be added to these compositions so that the advantageous properties inherently associated with the compounds of the present invention are not or are not substantially adversely affected by the intended addition.

[0357] In any case, multiple therapeutic agents (at least one of which is a compound of the invention) may be administered in any order or even simultaneously. If used simultaneously, the multiple therapeutic agents may be provided in a single unified form or in multiple forms (by way of example only, as a single pill or as two separate pills). One of the therapeutic agents may be given in multiple doses, or both may be given in multiple doses. If not simultaneously, the time intervals between multiple doses may be of any duration ranging from a few minutes to four weeks.

[0358] Thus, in another aspect, provided herein is a method for treating a disease, disorder, condition or symptom in a patient (e.g., a human or animal) in need of such treatment, the method comprising administering to the patient an amount of a compound of the present invention effective to alleviate or prevent the disease, disorder, condition or symptom, in combination with at least one other drug known in the art for treating the disease.

[0359] Any anti-pathogenic or anti-cancer composition described herein can be formulated for coating surfaces, including coating surfaces of medical devices, to prevent bacterial colonization, biofilm formation, and nosocomial infection. The use of medical devices (including long-term use) can lead to bacterial colonization, biofilm formation, and nosocomial bacterial infection (commonly known as hospital infection). This includes catheter-related bloodstream infections, plastic surgery implants, ventilator-related pneumonia, surgical site infections, and catheter-related urinary tract infections. This may require the removal and / or replacement of medical devices. Antipathogenic preparations (e.g., including amino acids and fatty acids) can be applied to the surface of medical devices in a variety of ways, including ion bonding to the surface, passive adsorption, or embedding the preparation in a polymer matrix. The preparation can be used in combination with other molecules, biofilm matrix degradation substances, or other antimicrobial agents. Any medical device can be coated as described herein, including, for example, implantable medical devices (stents, shunts, vascular occlusion coils, grafts, pins, plates, etc.) and non-implantable devices (catheters, masks, surgical tools, etc.).

[0360] Any method described herein (including user interfaces) may be implemented as software, hardware, or firmware and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., a computer, tablet, smartphone, etc.) which, when executed by the processor, causes the processor to control the execution of any steps, including but not limited to: displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, reminding, etc.

[0361] Fig.26 It is a table showing a matrix of examples of combining fatty acids (C4-C20 amino acids) with amino acids in a molar ratio of 1: 1. Individual cells indicate the ability of each specific combination to form a testable solution and provide an anti-pathogenic / anti-cancer effect. It can be seen that amino acids with charged basic side chains ("charged side chain-basic"), such as arginine, histidine and lysine, show a strong ability to form solutions and provide therapeutic effects. In this preliminary analysis, arginine and lysine were slightly more stable in forming miscible solutions compared to histidine. In addition, although virtually all fatty acids show the ability to bind to amino acids with charged basic side chains (arginine, histidine, lysine), C8-C20 fatty acids are slightly stronger. When only amino acids and fatty acids are mixed in a molar ratio of 1: 1, it is found that the combination marked "no" or represented by (-) is immiscible (therefore failing to show anti-pathogenic / anti-cancer effects). Example

[0362] An example of a therapeutically effective composition is referred to herein as GS-1. GS-1 is a composition of UCA and LARG, wherein the molar ratio of UCA:LARG is 5:4 (1:0.76 by weight). For example, GS-1 can be prepared by heating at 65 degrees Celsius and adding 15 grams of LARG to 75 grams of water and stirring until completely dissolved, and then adding 19.8 grams of UCA while heating and stirring.

[0363] Fig.13 The efficacy of GS-1 against eight isolates of methicillin-resistant Staphylococcus aureus (MRSA) at a drug dilution of 1:16 was shown. MRSA is Gram-positive. Fig.13 As shown, GS-1 causes almost universal, complete (100%) killing of MRSA isolates. In this example, bacteria (MRSA isolates) are placed on fresh plates and allowed to grow for 30 hours. A suspension inoculum (e.g., 1McFarland solution in sterile water) is prepared from the plate, from which turbidity can be optically read. A standard inoculum can then be cultured in culture medium, and 100 μL of this solution is then mixed with 100 μL of the drug product and grown for 16-20 hours at various dilutions. Repeated samples can then be checked (e.g., precipitated at 7,000 RPM for 15 minutes, resuspended in PBS, and serial dilutions are plated and grown for 24 hours). Repeated plates at multiple dilutions can then be imaged and colonies counted. The treated samples are compared with untreated samples (e.g., water containing no UCA and LARG) and inoculum (showing cell viability).

[0364] Fig.14 The therapeutic effect of the GS-1 composition on Escherichia coli (EC) is illustrated. Two Escherichia coli (EC) isolates were tested at a drug dilution of 1:16. As shown, at this dilution, the GS-1 composition completely killed (100%) the bacteria. The data were collected as described above and show the comparison between untreated bacteria and the inoculum.

[0365] Similarly, Fig.15 The in vitro efficacy of GS-1 against three isolates of CRE-positive Klebsiella pneumoniae (KPCRE) is demonstrated at a drug dilution of 1: 16. As with EC and MRSA, GS-1 completely killed (100%) bacteria of each isolate.

[0366] Fig.16 Similar efficacy of GS-1 against two isolates of Pseudomonas aeruginosa (PSA) was shown at a drug dilution of 1:8. In this example, all (100%) bacteria were killed. Similar results (>99.9% killed) were observed at a dilution of 1:16 (not shown).

[0367] GS-1 has also been found to have anticancer activity. For example, treatment of cultured rat glioma cancer cells with progressively diluted concentrations of GS-1 resulted in inhibition of all or nearly all cancer cells at a dilution of 1:128, and even significant inhibition at lower dilutions (e.g., 1:256 and 1:512), such as Fig.17 and 18A -18E. For example, Fig.17 In the present study, rat glioma cancer cells were cultured to approximately 90% confluence, trypsinized, and plated at high titers (e.g., 4,500 per well), allowed to settle and adhere overnight, and then treated with specific dose dilutions of GS-1. Serial cell dilutions were examined for each GS-1 dose, and the treated cells were cultured for 24 hours before the medium was replaced with fresh medium (including GS-1) and the MTS assay (based on the reduction of MTS tetrazolium compounds by live cells) was performed to quantify healthy cells by colorimetric changes. Fig.17 The percentage of inhibition of cancer cell proliferation compared to untreated cells is shown.

[0368] Figures 18A-18E Cancer cells treated with increasing dilutions of GS-1 are shown ( Figures 18A-18D ) and images of untreated cancer cells ( Fig.18E ). Each image is a micrograph showing the efficacy of GS-1 in killing C6 rat glioma cancer cells in vitro as a function of drug dilution. FIG. 18A to FIG. 18E Each of the figures shows a fluorescent image using a vital (e.g., PI) dye that is overlaid with a non-fluorescent image to visually show unhealthy cells (dead or dying cancer cells) relative to healthy cells. Figures 18A-18D As shown, unhealthy cells take up the PI dye and fluoresce, while healthy cells do not. Fig.17 Consistently, higher dilutions of GS-1 (1:64 and 1:128) were almost completely effective in killing cancer cells, with almost all cells fluorescing, whereas higher dilutions (e.g., 1:256 and 1:512) were less effective, with fewer cells fluorescing. Fig.18E No cells fluoresce in . Each of these images was taken at the same exposure to allow for comparison.

[0369] Studies testing the effects of GS-1 on 'normal' cells (including cells from healthy animals) showed that GS-1 showed no effect on normal cells compared to cancer cells, including at high (undiluted) concentrations.

[0370] Animal studies were also conducted to establish the in vivo safety and efficacy of GS-1. In one example study, 16 rats were given a dermal abrasion in an area of ​​4 x 4 cm and then infected with methicillin-resistant Staphylococcus aureus (MRSA). After 24 hours, half of the rats received GS-1 treatment and half received saline treatment (untreated control), twice a day for 7 days. At the end of the 7th day, skin swabs and tissue punches from the infected site were collected and analyzed for signs of infection (efficacy), and blood was drawn and analyzed for signs of toxicity (safety). All rats treated with GS-1 showed no signs of infection after 7 days, and no signs of toxicity or side effects compared to untreated control animals.

[0371] As noted above, generally speaking, the compositions described herein may include one or more fatty acids and one or more amino acids in a fatty acid:amino acid molar ratio of about 1:0.6 to about 1:1.6. Figure 1-1 8 illustrates a composition in which the fatty acid is UCA and the amino acid is LARG, however, the compositions and methods described herein are not limited to UCA and LARG. For example, Fig. 20 A comparison of a UCA / LARG composition ("GS-1") with mixtures of capric acid / LARG ("GS-2"), caprylic acid / LARG ("GS-3"), and linoleic acid / LARG ("GS-4") is shown, each of which exhibited significant antipathogenic activity at comparable concentrations compared to the untreated case and inoculum controls. For example, in Fig. 20 In each example, when diluted and used to treat MRSA, the weight ratio of fatty acids to amino acids in the composition was approximately 1:0.76 (fatty acids:amino acids). GS-1, GS-2, and GS-3 all had an aqueous mixture of fatty acids:amino acids with a total active pharmaceutical ingredient (API) of approximately 32% w / w, which was diluted in water at a ratio of 1:128 to a total API concentration of approximately 0.25% w / w. GS-4 had a total API concentration of approximately 1.64 mg / mL (0.16% w / w). Fig. 20 In the study, GS-1 and GS-2 produced almost complete bactericidal effects on MRSA (shown by the absence of bars), while GS-3 and GS-4 substantially reduced MRSA compared to untreated controls. It is important to note that GS-4 was used at a lower concentration than GS-1 to GS-3 (e.g., total API was 0.16% w / w instead of 0.25% w / w for GS-1 to GS-3). All of these results suggest that its efficacy is comparable to or even higher than that of commercially available antibiotics, such as the topical antibiotic mupirocin ("betroban").

[0372] Figure 21-23 Specific results for each of GS-2, GS-3 and GS-4 are shown. Fig.21The activity of the combination of capric acid and LARG (in a weight ratio of 1:0.76) was shown. Fig.21 In the treatment, the concentration was about 2.51 mg / mL (0.25% w / w) of total API (eg, decanoic acid and LARG). Six separate clinical isolates were treated with GS-2 in solution for 24 hours and resulted in complete killing (eg, 100% sterilization) of all MRSA present.

[0373] Fig. 22 A similar test using a composition comprising caprylic acid and LARG (GS-3) in a ratio of 1:0.76 w / w was shown. The concentration of caprylic acid / LARG in the treatment solution was 2.52 mg / mL (0.25% w / w) for the total API and was added to six clinical MRSA isolates and treated for 24 hours. In this assay, GS-3 (caprylic acid / LARG) produced an inhibitory effect on 66.7% of the isolates and a bacteriostatic effect on 33.3%. The concentration of the caprylic acid / LARG composition can be increased to obtain a complete bactericidal effect.

[0374] Fig.23 An example of combining a mixture of linoleic acid and LARG (GS-4) is shown. In this example, six MRSA clinical isolates were treated in solution for 24 hours using C18 linoleic acid at a total API concentration of 1.64 mg / mL (0.16% w / w). The GS-4 mixture produced a bactericidal effect on 50% of the isolates and an inhibitory effect on 50%.

[0375] Fig.24 An example of a composition of fatty acids and amino acids in a ratio of 1:0.76 w / w as described above is shown. In this example, the fatty acid is UCA and the amino acid is lysine (GS-5). Fig.24 As shown, five MRSA clinical isolates were treated with GS-5 (UCA / Lysine) at a total API concentration of 2.46 mg / mL (0.25% w / w) in solution for 24 hours. The GS-5 composition was bactericidal in all isolates, as shown (note the logarithmic scale).

[0376] Similarly, Fig.25 An example of a composition of a fatty acid and an amino acid is shown, wherein the amino acid is histidine. The complex of histidine and UCA may have a ratio of 1:0.76 w / w (e.g., a molar ratio of UCA:histidine of about 1.25:1). Fig.25As shown, histidine has significant bactericidal and bacteriostatic effects on methicillin-sensitive Staphylococcus aureus (MSSA). In this example, four clinical isolates were treated with GS-6 (UCA: histidine as described above) at a total API concentration of 2.71 mg / mL (0.25% w / w) in solution for 24 hours. GS-6 had a bactericidal effect (100%) in all isolates, as shown in Table 1. Fig.25 shown.

[0377] Thus, based on the data and other experiments, the amino acids vary with positively charged (basic at physiological pH) fatty acids (e.g., UCA: L-ARG, UCA: lysine, and UCA: histidine), while other amino acids are less effective (or ineffective, such as D-arginine and other uncharged amino acids) in producing a bactericidal effect. Thus, in some variations, the amino acids can be limited to charged (particularly positively charged) amino acids, such as amino acids with charged basic side chains.

[0378] Combination with other active agents

[0379] Typically, any therapeutic composition described herein may include one or more other ingredients that may act as or enhance the activity of fatty acids and amino acids. For example, any therapeutic composition described herein may be combined with one or more other active ingredients to provide different or enhanced properties, such as enhanced efficacy.

[0380] In some variations, the compositions described herein may include additional agents that destroy cell membranes. In some variations, the compositions described herein may include antibiotics, such as polymyxins (e.g., polymyxin B or polymyxin E), to further enhance efficacy. Typically, the therapeutic compositions described herein may be combined with one or more non-ribosomal peptides (e.g., actinomycin, bacitracin, daptomycin, vancomycin, tesabecin, tyrosine, gramicidin, amphotericin A, ACV-tripeptide, epothilone, bleomycin, cyclosporin (cyclosporin A), etc.). Additional components added together with the compositions described herein, such as polymyxins, may allow the use of substantially lower amounts of antibiotics and / or may significantly enhance the efficacy of antibiotics.

[0381] As described above, the compositions described herein have both anti-pathogenic (e.g., anti-bacterial, anti-viral, anti-fungal, etc.) and anti-cancer effects. Fig. 27A graph outlining the test results of one example of a composition described herein, comprising LARG and UCA (GS-1) in a molar ratio of approximately 1:1, is shown. In this example, in vitro activity against human cancer cells is shown. The graph shows untreated and treated values ​​for each of a variety of cancer cell lines. All results are for a working drug concentration of 0.3% w / w. All cancer cell lines examined showed a significant reduction in cancer cell viability 24 hours after exposure to the composition as measured by absorbance (e.g., absorbance at 493 nm). In this example, prostate cancer cells, breast cancer cells, melanoma cancer cells, leukemia cells, and lung cancer cells each showed a reduction after treatment with a 0.3% solution of GS-1.

[0382] Figure 28-32 The anti-cancer effect of one example of the therapeutic composition described herein (e.g., GS-1) is illustrated. Similar results may also be observed or expected to be observed with other therapeutic compositions comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, including for substantially all C4-C20 fatty acids and amino acids (including arginine, histidine and / or lysine, etc.).

[0383] For example, Fig.28 is a graph showing the results of a composition of a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, which showed anticancer efficacy against cultured PC3 human prostate cancer cells. The mixture is a mixture of LARG and UCA, treating human prostate cancer cells. Fig.28 In the experiment, the viability of cancer cells was completely reduced after 24 hours of treatment with 0.30% of the composition (GS-1), while the viability of cancer cells cultured with 0.150% of the composition was reduced by 99.5%. PC3 human prostate cancer cells were seeded on a sterile 96-well plate at 7000 cells per well. After 24 hours of growth, the cells were further incubated for 24 hours at 37 degrees Celsius with a dilution (GS-1-2) of 30% of the stock solution concentration of GS-1. After incubation, the culture medium and the test article were removed and replaced with fresh preheated culture medium. 20 μL MTS was added to each well containing 100 μL culture medium and incubated for 2 hours. After incubation, analysis was performed on a 96-well colorimetric plate reader. All data were blank-subtracted using 100 μL culture medium and 20 μL MTS-deficient cells (n=12 wells per treatment, n=24 wells without treatment). Error bars are standard deviations.

[0384] Similar results were observed with cultured breast cancer cells. Fig.29In the figure, the MTS cell viability obtained after MCF7 breast cancer cells were seeded on a sterile 96-well plate at 7000 cells per well was measured. After 24 hours of growth, the cells were incubated with a dilution of GS-1 from a 30% stock solution concentration (GS-1-2) at 37 degrees Celsius for 24 hours. After incubation, the culture medium and test article were removed and replaced with fresh preheated culture medium. 20 μL of MTS was added to each well containing 100 μL of culture medium and incubated for 2 hours. After incubation, the plate was analyzed on a 96-well colorimetric plate reader. All data were blank-subtracted (12 wells per treatment, 12 wells untreated) using 100 μL of culture medium and 20 μL of MTS-deficient cells. Incubation with 0.300% of the composition (GS-1) showed that the viability of cultured breast cancer cells was reduced by 89.8%.

[0385] Fig.30 Results of treatment of cultured human skin cancer (MM170 human melanoma cells) after 24 hours of treatment are shown. Fig.30 MM170 human melanoma cells were seeded onto sterile 96-well plates at 7,000 cells per well. As described above, after 24 hours of growth, the cells were incubated at 37 degrees Celsius with dilutions of GS-1 (from a 30% stock solution) for 24 hours. After incubation, the culture medium and test article were removed and replaced with fresh preheated culture medium. 20 μL MTS was added to each well containing 100 μL culture medium and incubated for 2 hours. After incubation, analysis was performed on a 96-well colorimetric plate reader. All data were blank-subtracted using 100 μL culture medium + 20 μL MTS-deficient cells. Treated wells = 12 wells. Untreated wells = 24. Error bars represent standard deviations. A complete reduction in viability (e.g., 100%) was observed using a concentration of 0.300%.

[0386] Treatment of cultured human leukemia cells showed a similar trend; incubation with a 0.075% solution resulted in a 99.8% reduction in the viability of cultured cells. U937 human leukemia cells were seeded onto sterile 96-well plates at 7,000 cells per well. After 24 hours of growth, the cells were incubated with GS-1 dilutions (from a 30% stock concentration) at 37 degrees Celsius for 24 hours. After incubation, the culture medium and test article were removed and replaced with fresh pre-warmed culture medium. 20 μL of MTS was added to each well containing 100 μL of culture medium and incubated for 2 hours. After incubation, analysis was performed on a 96-well colorimetric plate reader. All data were blank-subtracted using 100 μL of culture medium and 20 μL of MTS-deficient cells. Treated wells: n=4 (3 wells per n; 12 wells in total). Untreated wells n=8 (3 wells per n; 24 wells in total).

[0387] After treatment with a 0.30% solution of the GS-1 therapeutic composition, cultured human lung cancer cells (A549 human alveolar adenocarcinoma cells) also showed an almost complete reduction in viability (e.g., to 98.8%), as shown in FIG. Fig.32 As shown. A549 human lung cancer cells were seeded onto sterile 96-well plates at 7,000 cells per well. As described above, after 24 hours of growth, the cells were incubated with dilutions of GS-1 (from a 30% stock concentration) at 37 degrees Celsius for 24 hours. After incubation, the culture medium and test article were removed and replaced with fresh preheated culture medium. 20 μL of MTS was added to each well containing 100 μL of culture medium and incubated for 2 hours. After incubation, analysis was performed on a 96-well colorimetric plate reader. All data were blank-subtracted using 100 μL of culture medium and 20 μL of MTS-deficient cells. n = 12 wells per treatment (3 replicates x 4). n = 35 wells without treatment. Error bars are standard deviations.

[0388] As mentioned above, similar anticancer results were observed using other combinations of amino acids and fatty acids. Fig.33 is a graph showing very similar data for GS-2 (a mixture of LARG and capric acid). Fig.33 In, the effect of GS-2 on A549 human alveolar adenocarcinoma cells is shown. At a GS-2 concentration of 0.300%, it was found that the viability of lung cancer cells was reduced by 98.2%. As described above for GS-1, A549 human lung cancer cells were seeded on a sterile 96-well plate at 7,000 cells per well. After 24 hours of growth, the cells were incubated at 37 degrees Celsius with GS-2 dilutions (from a stock solution concentration of 30%) for 24 hours. After incubation, the culture medium and the test article were removed and replaced with fresh preheated culture medium. 20 μL of MTS was added to each well containing 100 μL of culture medium and incubated for 2 hours. After incubation, analysis was performed on a 96-well colorimetric plate reader. All data were blank-subtracted using 100 μL culture medium and 20 μL MTS-deficient cells. n = 12 wells (3 replicates x 4) per treatment. Untreated group, n = 70 wells. Error bars are standard deviations.

[0389] As described above, these therapeutic compositions having a molar ratio of fatty acid:amino acid of about 1:0.6 to about 1:1.6 are also effective antiviral agents. For example, Fig.34 is a graph showing the efficacy of these therapeutic compositions against HSV infected cells. In this graph, two GS-1 concentrations were shown to be effective against HSV infected cells (150 μg / mL and 75 μg / mL). Fig.35An example of a therapeutic composition of fatty acids: amino acids (e.g., GS-1) was shown to have similar results against pseudo-Ebola infected cells at three working concentrations. Preliminary results showed the same effects when these therapeutic compositions were used to treat other viral agents such as influenza and smallpox.

[0390] Thus, the compositions described herein are generally effective against bacteria, including both Gram-positive and Gram-negative bacteria. For example, GS-1 and GS-2 (as well as all other fatty acid: amino acid therapeutic compositions within the specified molar ratios tested) exhibited active antibacterial effects against both Gram-positive and Gram-negative bacteria. For example, any of the fatty acid: amino acid therapeutic compositions described herein also exhibited efficacy against Clostridium difficile (C. difficile) (data not shown).

[0391] System security

[0392] Systemic safety studies from rodents have shown that the therapeutic compositions described herein (e.g., therapeutic compositions having a molar ratio of fatty acid:amino acid of about 1:0.6 to about 1:1.6) are safe even at relatively high concentrations. Therefore, these compositions can be administered locally and / or systemically to treat patients in need thereof (e.g., for anti-pathogenic reasons and / or for the purpose of anti-cancer treatment). For example, in one study, an exemplary composition (e.g., GS-1) was administered by subcutaneous injection at a full strength 1.25 mL / kg dose level (corresponding to 381 mg / kg API) as a single dose. No side effects were observed.

[0393] In another study, GS-2 was administered as a single dose at full strength at a dose level of 10 mL / kg (corresponding to 3050 mg / kg of API) by subcutaneous injection. No side effects were observed. GS-2 was also administered once daily by subcutaneous injection at a dose level of 5 mL / kg (equivalent to 1525 mg / kg of API) for 14 days. No side effects were observed.

[0394] Antimicrobial coatings and additives

[0395] As mentioned above, the compositions described herein can be used for coatings and / or additives, including, for example, material additives to paints (pain), plastics, etc. For example, GS-1 is used to coat central venous catheters to provide antimicrobial activity against Gram-positive bacteria (MRSA) and Gram-negative bacteria (E. coli). In head-to-head testing, GS-1 provides performance equal to or better than chlorhexidine and silver coatings already used on the market. Coatings can be applied by spraying, dipping, etc. Coatings can be encapsulated, partially encapsulated, and / or unencapsulated.

[0396] The therapeutic compositions described herein can also be used as additives. For example, GS-1 was added to commercially available water-based coatings at concentrations of 5% w / w, 10% w / w, and 20% w / w to provide antimicrobial activity. At all concentrations, the GS-1 additive successfully eliminated Gram-positive bacteria (MRSA) and Gram-negative bacteria (E. coli) inoculated onto the surface within 24 hours. GS-1 was also added to commercially available plastics (polyurethane) at concentrations of 5% w / w and 10% w / w to provide antimicrobial properties. At both concentrations, the GS-1 additive successfully eliminated Gram-positive bacteria (MRSA) and Gram-negative bacteria (E. coli) inoculated onto the surface within 24 hours.

[0397] The methods and compositions described herein can also be used for non-medical / health applications, including industrial uses. In general, these methods and compositions can be used for any process or application in which amino acids can be used to solubilize fatty acids. Fatty acids are used in many industrial applications due to their carbon skeletons, such as for the manufacture of nylon. A common problem with the use of fatty acids is that they are insoluble and only liquid at high temperatures (thus requiring a lot of energy to heat). The methods and compositions described herein, in which amino acids, particularly amino acids with charged basic side chains (e.g., lysine, histidine, arginine) can be used to solubilize fatty acids (e.g., C4-C40 fatty acids, C4-C20 fatty acids, C8-C20 fatty acids, C8-C18 fatty acids, etc.), the molar ratio of the amino acids to the fatty acids is about 1:0.6 to about 1:1.6, and therefore may be beneficial at any time when fatty acids are needed in the solution.

[0398] dose

[0399] Generally, any suitable dosage can be used as part of the treatment described herein. Initial studies have shown that the compositions described herein can be provided in a dosage range, for which very low concentrations (e.g., less than 0.1% w / w) may be effective, but even higher concentrations may be effective and have little (if any) side effects. For example, any method described herein can be used to treat subjects in the range between about 30% w / w and about 0.001% w / w. In some variations, a dose of about 15% w / w to about 0.01% w / w can be given to a patient. A dose between about 10% to about 0.01% w / w can be used to treat a patient. A dose between about 5% to about 0.01% w / w can be used to treat a patient. In some variations, a dose between about 2.5% to about 0.01% w / w can be used to treat a patient. In some variations, a dose between about 1% to about 0.01% w / w can be used to treat a patient. In some variations, a dose between about 0.5% to about 0.001% w / w can be used to treat a patient. In some variations, a patient may be treated with a dosage of between about 0.25% and about 0.001% w / w. In some variations, a patient may be treated with a dosage of between about 0.25% and about 0.01% w / w.

[0400] More than one dose may be provided (e.g., 1x per day, 2x per day, 3x per day, 4x per day, 5x per day, etc., once every 36 hours, once every 48 hours, once every 60 hours, once per week, etc.).

[0401] stability

[0402] Typically, the therapeutic compositions described herein may include a ratio of fatty acids (e.g., undecylenic acid) and amino acids (e.g., L-arginine) that are stable for storage. For example, a molar ratio of UCA to LARG (UCA:LARG) of, for example, about 1:0.6 to about 1:1.6 (particularly about 1:0.65 to 1:1.4, such as about 1:0.65 to 1:1.3, about 1:0.65 to 1:1, etc.) may be stable for days, weeks, or months at temperatures above 0 degrees Celsius. Further in some variations, the compositions described herein (e.g., compositions of UCA and LARG) may be stable for a long time, such as greater than 24 hours (greater than 2 days, 3 days, 4 days, 7 days, 10 days, 14 days, 21 days, 30 days, 60 days, 120 days, 6 months, 1 year, etc.) at even lower temperatures, particularly at temperatures such as -20°C.

[0403] In particular, compositions of UCA and LARG having a molar ratio of about 1:1 (e.g., about 1:0.95 by weight) or about 5:4 (e.g., about 1:0.76 by weight) can be particularly stable at lower temperatures and for longer periods of time. See, e.g., Fig.19 .exist Fig.19 (Table 3) shows the results of freeze stability (24 hours at -20 degrees Celsius), indicating that the molar ratio of UCA to LARG of 1:1 (e.g., about 1:0.95 by weight) and 5:4 (e.g., 1:0.76 by weight) showed excellent stability at lower temperatures compared to other ratios of UCA:LARG. Fig.19 All tested compositions can be effectively used as antipathogen and / or anticancer compositions, and all tested compositions can remain stable for a long time when stored under conditions above freezing (e.g., >0 degrees Celsius >24 hours), but are exceptionally stable when the molar ratio of UCA:LARG is 1:1 and 5:4. In any of these examples, additional stabilizers can be included to enhance stability.

[0404] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an" and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise. It will be further understood that when the terms "include" and / or "comprise" are used in this specification, the presence of the stated features, steps, operations, elements and / or components is specified, but the presence or increase of one or more other features, steps, operations, elements, components and / or groups is not excluded. As used herein, the term "and / or" includes any and all combinations of one or more related listed items and can be abbreviated as " / ".

[0405] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, without departing from the teachings of the present invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0406] Throughout this specification and the following items, unless the context requires otherwise, the word "comprise" and words such as "contain" and "include" are used to mean that various components (such as compositions and devices including devices and methods) can be used together in methods and articles. For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0407] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or "consisting essentially of" various components, steps, subcomponents or sub-steps.

[0408] As used in the specification and project book, including in the examples, and unless otherwise explicitly stated, all numbers can be interpreted as starting with the word "about" or "approximately", even if the term does not appear explicitly. When describing the amplitude and / or position, the phrase "about" or "approximately" can be used to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, the value of the numerical value can be + / -0.1% of the specified value (or numerical range), + / -1% of the specified value (or numerical range), + / -2% of the specified value (or numerical range), + / -5% of the specified value (or numerical range), + / -10% of the specified value (or numerical range), etc. Any numerical value given here should also be understood to include about or approximately the value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all sub-ranges contained therein. It should also be understood that, as appropriately understood by the technician, when a numerical value is disclosed, "less than or equal to" the value, "greater than or equal to the value" and the possible range between these values ​​are also disclosed. For example, if a value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed, as well as between 10 and 15. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0409] Although various illustrative embodiments are described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the invention described in the project. For example, in alternative embodiments, the order in which the various method steps described may be performed may often be changed, while in other alternative embodiments, one or more method steps may be skipped. Optional features of various device and system embodiments may be included in some embodiments, while in other embodiments, they may not be included. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention, as set forth in the project.

[0410] The embodiments and illustrations included herein show the specific embodiments that the subject matter of the present invention can be implemented by way of illustration and not limitation. As mentioned, other embodiments can be used and other embodiments can be derived therefrom, so that structural and logical replacement and change can be performed without departing from the scope of the present disclosure. Only for convenience, the term "invention" can be used individually or collectively herein to refer to these embodiments of the subject matter of the present invention, without intending to limit the scope of the present application to any single invention or inventive concept (if the present invention in fact discloses multiple). Therefore, although specific embodiments have been illustrated and described herein, any scheme calculated for achieving the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or changes of various embodiments. By reading the above description, the combination of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A therapeutic composition for use as an antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6 and an antibiotic, wherein the amino acid is L-arginine, and wherein the fatty acid is undecylenic acid, further wherein the antibiotic is not a fatty acid.

2. The composition of claim 1, wherein the antibiotic comprises an agent that disrupts cell membranes.

3. The composition of claim 1, wherein the antibiotic comprises one or more non-ribosomal peptides.

4. The composition of claim 1, wherein the antibiotic comprises polymyxin.

5. The composition of claim 1, wherein the total concentration of the fatty acid:amino acid mixture is from about 35% to about 0.001% w / w.

6. The composition of claim 1, wherein the molar ratio of fatty acid:amino acid is between 1:0.6 and about 1:

1.

7. The composition of claim 1, wherein the molar ratio of fatty acid:amino acid is about a 1:1 molar ratio.

8. The composition of claim 1, wherein the molar ratio of fatty acid:amino acid is about a 5:4 molar ratio.

9. The composition of claim 1, wherein the composition is an aqueous composition.

10. The composition of claim 1, wherein the pH of the composition is between 6 and 10.

11. The composition of claim 1, wherein the pH of the composition is between 6.9 and 7.

8.

12. The composition of claim 1, further comprising an excipient other than cetyl alcohol.

13. The composition of claim 9, wherein the excipient is formulated for topical administration.

14. The composition of claim 9, wherein the excipient comprises an emulsifier.

15. The composition of claim 1, further comprising a cooling or heating additive.

16. The composition of claim 1, wherein the composition is formulated as a liquid in a form suitable for topical administration to a human.

17. The composition of claim 1, wherein the composition is formulated for one or more of: oral, intraperitoneal, transdermal, rectal, and inhalable administration.

18. The composition of claim 1, wherein the composition is configured for coating a medical device.

19. The composition of claim 1, wherein the composition is formulated as an emulsion in a form suitable for topical administration to humans.

20. The composition of claim 1, wherein the composition is formulated for parenteral administration.

21. The composition of claim 1, wherein the composition is formulated for transmucosal administration.

22. The composition of claim 1, wherein the composition is formulated for topical administration.

23. A composition comprising an aqueous solution of a mixture of undecylenic acid:L-arginine, the mixture forming a complex of undecylenic acid and arginine in a molar ratio of 1:0.6 to 1:1.

6.

24. The composition of claim 23, wherein the composition comprises at least 0.001% w / w of a complex of undecylenic acid:L-arginine.

25. The composition of claim 23, wherein the molar ratio of undecylenic acid:L-arginine is 1:0.6 to 1:1.

2.

26. The composition of claim 23, wherein the molar ratio of undecylenic acid:L-arginine is about a 1:1 molar ratio.

27. The composition of claim 23, wherein the composition is substantially free of cetyl alcohol and rhein.

28. The composition of claim 23, further comprising an excipient, a diluent, a carrier or a flavoring agent.

29. The composition of claim 28, wherein the excipient, diluent, carrier or fragrance is suitable for topical administration or application to a surface.

30. The composition of claim 23, wherein the composition is formulated as a liquid, emulsion, solution, ointment, or cream in a form suitable for topical administration to a human or application to a surface.

31. The composition of claim 23, wherein the composition is formulated for one or more of oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalable, and topical administration.

32. The composition of claim 23, wherein the composition is formulated for administration as a hand sanitizer or a surface sanitizer.

33. The composition of claim 23, further comprising benzalkonium chloride.

34. A composition comprising an aqueous solution of a complex of undecylenic acid:L-arginine, wherein the molar ratio of undecylenic acid:L-arginine is from 1:0.6 to 1:1.6, and the total concentration is at least about 0.001% w / w, wherein the composition is substantially free of cetyl alcohol.

35. The composition of claim 34, wherein the molar ratio of undecylenic acid:L-arginine is 1:0.6 to 1:1.

2.

36. The composition of claim 34, wherein the molar ratio of undecylenic acid:L-arginine is about a 1:1 molar ratio.

37. The composition of claim 34, further comprising an excipient, a diluent, a carrier or a flavoring agent.

38. The composition of claim 37, wherein the excipient, diluent, carrier or fragrance is suitable for topical administration or application to a surface.

39. The composition of claim 34, wherein the composition is formulated as a liquid, emulsion, solution, ointment or cream in a form suitable for topical administration to a human or application to a surface.

40. The composition of claim 34, wherein the composition is formulated for one or more of oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalable, and topical administration.

41. The composition of claim 34, further comprising benzalkonium chloride.

42. The composition of claim 34, wherein the composition is formulated for administration as a hand sanitizer or a surface sanitizer.

43. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of an antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6 as a complex, wherein the total concentration of undecylenic acid:L-arginine is at least about 0.001% w / w.

44. The method of claim 43, wherein the molar ratio of undecylenic acid:L-arginine is about a 1:1 molar ratio.

45. The method of claim 43, wherein the antipathogenic composition is an aqueous composition.

46. ​​The method of claim 43, wherein administering comprises applying the antipathogenic composition to the skin of the patient.

47. The method of claim 43, wherein the pathogen is one or more of: gram-negative bacteria, gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli, and viruses.

48. A method of treating a surface to destroy pathogens, the method comprising: Applying to the surface an effective amount of a composition sufficient to kill, inactivate or inhibit the pathogen, the composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6 as a complex, wherein the total concentration of undecylenic acid:L-arginine is at least about 0.001% w / w.

49. The method of claim 48, wherein the molar ratio of undecylenic acid:L-arginine is about a 1:1 molar ratio.

50. The method of claim 48, wherein administering comprises administering the composition to disinfect a surface.

51. A composition comprising an aqueous solution of a mixture of capric acid:L-arginine, said mixture forming a complex of capric acid and arginine in a molar ratio of 1:0.6 to 1:1.

6.

52. The composition of claim 51, wherein the composition comprises at least 0.001% w / w of a complex of capric acid:L-arginine.

53. The composition of claim 51 or claim 52, wherein the molar ratio of capric acid:L-arginine is from 1:0.6 to 1:1.

2.

54. The composition of claim 51 or claim 52, wherein the molar ratio of capric acid:L-arginine is about a 1:1 molar ratio.

55. The composition of claim 51, wherein the composition is substantially free of cetyl alcohol and rhein.

56. The composition of any one of claims 51 to 55, further comprising an excipient, a diluent, a carrier or a flavoring agent.

57. The composition of claim 56, wherein the excipient, diluent, carrier or fragrance is suitable for topical administration or application to a surface.

58. The composition of any one of claims 51 to 57, wherein the composition is formulated as a liquid, emulsion, solution, ointment or cream in a form suitable for topical administration to a human or application to a surface.

59. The composition of any one of claims 51 to 56, wherein the composition is configured for one or more of oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalable, and topical administration.

60. The composition of any one of claims 51 to 59, wherein the composition is formulated for administration as a hand sanitizer or a surface sanitizer.

61. The composition of any one of claims 51 to 58, further comprising benzalkonium chloride.

62. A composition comprising an aqueous solution of a complex of capric acid:L-arginine, wherein the molar ratio of capric acid:L-arginine is from 1:0.6 to 1:1.6, and the total concentration is at least about 0.001% w / w, wherein the composition is substantially free of cetyl alcohol.

63. The composition of claim 62, wherein the molar ratio of capric acid:L-arginine is 1:0.6 to 1:1.

2.

64. The composition of claim 62, wherein the molar ratio of capric acid:L-arginine is about a 1:1 molar ratio.

65. The composition of any one of claims 62-64, further comprising an excipient, a diluent, a carrier or a flavorant.

66. The composition of claim 65, wherein the excipient, diluent, carrier or fragrance is suitable for topical administration or application to a surface.

67. The composition of any one of claims 62-66, wherein the composition is formulated as a liquid, emulsion, solution, ointment or cream in a form suitable for topical administration to a human or application to a surface.

68. The composition of any of claims 62-65, wherein the composition is formulated for one or more of oral, parenteral, intraperitoneal, transmucosal, transdermal, rectal, inhalable, and topical administration.

69. The composition of any one of claims 62-67, further comprising benzalkonium chloride.

70. The composition of any one of claims 62-69, wherein the composition is formulated for administration as a hand sanitizer or a surface sanitizer.

71. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of an antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6 as a complex, wherein the total concentration of capric acid:L-arginine is at least about 0.001% w / w.

72. The method of claim 61, wherein the molar ratio of capric acid:L-arginine is about a 1:1 molar ratio.

73. The method of claim 61, wherein the antipathogenic composition is an aqueous composition.

74. The method of any one of claims 61-63, wherein administering comprises applying the antipathogenic composition to the skin of the patient.

75. The method of any one of claims 61-64, wherein the pathogen is one or more of: gram-negative bacteria, gram-positive bacteria, fungi, mycobacteria, pneumonia bacteria, Escherichia coli, and viruses.

76. A method of treating a surface to destroy pathogens, the method comprising: Applying to the surface an effective amount of a composition sufficient to kill, inactivate or inhibit the pathogen, the composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6 as a complex, wherein the total concentration of capric acid:L-arginine is at least about 0.001% w / w.

77. The method of claim 66, wherein the molar ratio of capric acid:L-arginine is about a 1:1 molar ratio.

78. The method of claim 66 or 67, wherein administering comprises administering the composition to disinfect a surface.

79. Use of an antipathogenic composition in the manufacture of a medicament for administration to a patient to destroy pathogens, wherein the antipathogenic composition comprises a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6 as a complex, wherein the total concentration of capric acid:L-arginine is at least about 0.001% w / w.

80. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.

6.

81. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

82. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

83. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are amino acids with charged basic side chains.

84. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

85. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

86. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of an antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.

6.

87. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

88. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

89. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are amino acids having charged basic side chains.

90. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

91. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

92. A method of treating a patient to destroy cancer, the method comprising: A therapeutically effective amount of a therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of between about 1:0.6 and about 1:1.6 is administered to the patient.

93. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of fatty acids:amino acids at a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids.

94. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of fatty acids:amino acids at a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids.

95. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of fatty acids:amino acids at a molar ratio of between about 1:0.6 and about 1:1.6, wherein the amino acids are amino acids with charged basic side chains.

96. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of fatty acids:amino acids at a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C40 fatty acids and the amino acids are amino acids with charged basic side chains.

97. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of fatty acids:amino acids at a molar ratio of between about 1:0.6 and about 1:1.6, wherein the fatty acids are C4 to C20 fatty acids and the amino acids are amino acids with charged basic side chains.

98. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acids are one or more of: L-arginine, histidine, and lysine.

99. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C40 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

100. A therapeutic composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

101. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6 is administered to a patient in need thereof, wherein the amino acids are one or more of: arginine, histidine, and lysine.

102. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of a composition is administered to a patient in need thereof, the composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

103. A method of treating cancer, the method comprising: A therapeutically effective amount of a composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6 is administered to a patient in need thereof, wherein the amino acids are one or more of the following: arginine, histidine, and lysine.

104. A method of treating cancer, the method comprising: A therapeutically effective amount of a composition is administered to a patient in need thereof, the composition comprising a mixture of fatty acids:amino acids in a molar ratio of about 1:0.6 to about 1:1.6, wherein the fatty acids are one or more of the following: C4-C20 fatty acids, and the amino acids are one or more of the following: arginine, histidine, and lysine.

105. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.

6.

106. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

107. A therapeutic composition comprising a mixture of undecylenic acid:L-arginine at a total concentration of about 35% to about 0.001% w / w and a molar ratio of about 1:0.6 to about 1:

1.

108. A therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.

6.

109. A therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

110. A therapeutic composition comprising a mixture of capric acid:L-arginine at a total concentration of about 35% to about 0.001% w / w and a molar ratio of about 1:0.6 to about 1:

1.

111. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of an antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.

6.

112. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

113. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of undecylenic acid:amino acid in a molar ratio of about 1:0.6 to about 1:1.6, wherein the amino acid is one or more of the following: L-arginine, lysine, and histidine.

114. A method of treating a patient to destroy a pathogen, the method comprising: A therapeutically effective amount of an antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of capric acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.

6.

115. A method of treating a patient with an anti-pathogen composition to destroy a pathogen, the method comprising: A therapeutically effective amount of the antipathogenic composition is administered to the patient, the antipathogenic composition comprising a mixture of capric acid:L-arginine in a molar ratio of between about 1:0.6 and about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

116. A method of treating a patient with an anti-pathogenic composition to destroy a pathogen, the method comprising: The patient is administered a therapeutically effective amount of the antipathogenic composition, the antipathogenic composition comprising a molar ratio of about 1:0.6 to about 1: 1.6 Capric acid: a mixture of amino acids, wherein the amino acids are one or more of the following: L-arginine, lysine and histidine.

117. A method of treating a patient to destroy cancer, the method comprising: A therapeutically effective amount of a therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.

6.

118. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of undecylenic acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

119. A method of treating a patient to destroy cancer, the method comprising: A therapeutically effective amount of a therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.

6.

120. A method of treating a patient with a therapeutic composition to destroy cancer, the method comprising: A therapeutically effective amount of the therapeutic composition is administered to the patient, the therapeutic composition comprising a mixture of capric acid:L-arginine in a molar ratio of about 1:0.6 to about 1:1.6, wherein the therapeutic composition does not comprise cetyl alcohol.

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