USE OF A POLYPHENOL FOR THE TREATMENT OF A CANCEROUS OR PRE-CANCEROUS LESION OF THE SKIN

• US 20130245113A1
• Filed: 05/07/2013
• Published: 09/19/2013
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: Fougera Pharmaceuticals Incorporated (Novartis Ag)
• Original Assignee: Medigene AG
• Inventors: STOCKFLETH, Eggert
• Granted Patent: US 9,060,998 B2
• Time in Patent Office: Days
• US Class Current: 514/456
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 36/82 Theaceae (Tea family), e.g. camellia
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

The present invention refers to a method for treating cancerous or precancerous lesions of the skin by administering a pharmaceutically effective amount of a polyphenol to a patient as well as to the production of a medicament thereto.

Claims

1-34. -34. (canceled)

35. A method of treating lesions of the skin of a patient, said lesion being selected from the group consisting of skin cancer, cutaneous carcinoma, basal cell carcinoma, squamous cell carcinoma, epithelioma, epithelial tumors, skin neoplasm, Bowen'"'"'s disease, acanthoma, cancroid, cutaneous horn, lid tumors, xanthelasma, xanthoma, fibroma, verucca senilis, cheilocarcinoma, papillomatosis, penis carcinoma, radiodermatitis, sailor'"'"'s skin, tar cancer, vaginal carcinoma, vulvar cancer, erythroplasia queyrat and carcinoma of the tongue, said method comprising topically administering to the skin lesion a pharmaceutically effective amount of a polyphenol composition comprising (i) a mixture of polyphenols and (ii) a carrier, wherein the composition comprises from about 5% (w/w) to about 20% (w/w) of the mixture of polyphenols, wherein the mixture of polyphenols contains epicatechol, epicatechol gallate, epigallocatechol, epigallocatechol gallate, and gallocatechol gallate.

36. The method according to claim 35, wherein the patient is a human.

37. The method according to claim 35, wherein the polyphenol is isolated from tea or a tea extract.

38. The method according to claim 37, wherein the tea is a green tea.

39. The method according to claim 35, wherein the mixture of polyphenols contains (−

)-epicatechol, (−

)-epicatechol gallate, (−

)-epigallocatechol, (−

)-epigallocatechol gallate, and (−

)-gallocatechol gallate.

40. The method according to claim 35, wherein the mixture of polyphenols contains about 2-20% (w/w) epicatechol, about 2-20% (w/w) epicatechol gallate, about 1-25% (w/w) epigallocatechol, about 40-75% (w/w) epigallocatechol gallate, and about 0.5-20% (w/w) gallocatechol gallate.

41. The method according to claim 40, wherein the mixture of polyphenols contains about 10.8% (w/w) of (−

)-epicatechol, about 6.5% (w/w) of (−

)-epicatechol gallate, about 9.2% (w/w) of (−

)-epigallocatechol, about 54.8% (w/w) of (−

)-epigallocatechol gallate, and about 4.0% (w/w) of (−

)-gallocatechol gallate.

42. The method according to claim 35, wherein the mixture of polyphenols is combined with an additive.

43. The method according to claim 42, wherein the additive is selected from the group consisting of petroleum jelly, wax, oleyl alcohol, propylene glycol monostearate, propylene glycol monopalmitostearate, and isopropyl myristate.

44. The method according to claim 35, wherein the polyphenol composition contained in a carrier selected from the group consisting of an emulsion, a gel, a cream, and an ointment.

45. The method according to claim 35, wherein the method for treating said lesions is combined with a different anticancer treatment.

46. The method according to claim 45, wherein the different anticancer treatment is selected from the group consisting of surgery, electrodessication, curettage, excision, Mohs micrographic surgery, radiation, proton therapy, chemotherapy, photodynamic therapy, cryosurgery, laser, immunotherapy, vaccine therapy, and biologic therapy.

47. The method according to claim 35, wherein the composition comprises about 15% (w/w) mixture of polyphenols.