Claims for Patent: 6,759,064

Summary for Patent: 6,759,064

Title:	Compositions based on vanilloid-catechin synergies for prevention and treatment of cancer
Abstract:	The invention described herein encompasses methods and compositions of preventing or treating cancer comprising the administration of a combination of catechins and vanilloids. Compositions of catechins include but not limited to, epigallocatechin gallate (EGCg), epicatechin (EC), epicatechin gallate (ECG), epigallocatechin (EGC). In a preferred embodiment the catechins have been treated with tannase. Compositions of vanilloids include, but are not limited to vanillylamine, the head group of capsaicin. The unique compositions of the invention contain various combinations of the catechins and vanilloids, in combination with each other or other therapeutic agents and are used to treat primary and metastatic cancers in humans. The invention also encompasses various modes of administration of the therapeutic compounds, including formulations which may be used as a dietary or nutritional supplement or as a therapeutic compound.
Inventor(s):	Morre ; Dorothy M. (West Lafayette, IN), Morre ; D. James (West Lafayette, IN)
Assignee:	Purdue Research Foundation (West Lafayette, IN)
Application Number:	10/081,903
Patent Claims:	1. A method for inhibition or treatment of a cancer in a mammal, said method comprising administering to a mammal a composition comprising tea catechins and vanilloids, in amounts effective to inhibit or treat the cancer, wherein the ratio of EC to EGCg concentration in said tea catechins is from about 10:1 to about 1000:1. 2. A method for inhibition or treatment of a cancer in a mammal, said method comprising administering to a mammal a composition comprising tea catechins adjunctively with a composition comprising vanilloids, wherein the amounts of tea catechins and vanilloids administered are effective to inhibit or treat the cancer, wherein the ratio of EC to EGCg concentration in said tea catechins is from about 10:1 to about 1000:1. 3. The method of claim 1 or 2 wherein the ratio of EC to EGCg concentration is about 100:1. 4. The method of claim 1 or 2 wherein the ratio of EC to EGCg concentration is about 1000:1. 5. The methods of claim 1 or 2 wherein gallic acid has been removed from the composition. 6. The method of claim 1 or 2 wherein the mammal is a human. 7. The method of claim 1 or 2 wherein the cancer is selected from a group comprising rectal carcinoma, colon carcinoma, breast carcinoma, ovarian carcinoma, small cell lung carcinoma, colon carcinoma, chronic lymphocytic carcinoma, hairy cell leukemia, osophogeal carcinoma, prostate carcinoma, breast cancer, myeloma, and lymphoma. 8. The method of claim 1 or 2 wherein the cancer is a tumor and wherein said tumor is a tumor of epithelial tissue, lymphoid tissue, connective tissue, bone, or central nervous system. 9. The method of claim 6 wherein the human is immunosuppressed by reason of having undergone anti-cancer therapy. 10. The method of claim 1 or 2 wherein the cancer is a metastases. 11. The method of claim 1 or 2 wherein the level of tea catechins and vanilloids is maintained at constant levels in the sera for at least 48 hours. 12. The method of claim 1 wherein said composition of tea catechins and vanilloids is a sustained release formulation and comprises at least one component which controls the release of said catechins and/or vanilloids. 13. The method of claim 2 wherein said composition of tea catechins or said composition of vanilloids or both are sustained release formulations and comprises at least one component which controls the release of said catechins and/or vanilloids. 14. A method for treatment of a cancer in a mammal, said method comprising administering to a mammal a composition comprising tea catechins and vanilloids, or pharmaceutically acceptable salts thereof, in combination with an effective amount of at least one other anti-cancer agent, in amounts effective to treat the cancer, wherein the cancer is a type having cancer cells which express tNOX, and wherein the ratio of EC to EGCg concentration in said tea catechins is from about 10:1 to about 1000:1. 15. The method of claim 14 in which said other anti-cancer agent is selected from a group consisting of adriamycin and adriamycin conjugates, mechlorethamine, cyclophosphamide, ifosfamide, melphalan, chlorambucil, hexamethylmelamine, thiotepa, busulfan, carmustine, lomustine, semustine, streptozocin, dacarbazine, methotrexate, fluorouacil, floxuridie, cytarabine, mercaptopurine, thioguanine, pentostatin, vinblastine, vincristine, etoposide, teniposide, actinomycin D, daunorubicin, doxorubicin, bleomycin, plicamycin, mitomycin, L-asparaginase, interferon-alpha, cisplatin, carboplatin, mitoxantrone, hydroxyurea, procarbazine, mitotane, aminoglutethimide, prednisone, hydroxyprogesterone caproate, medroxyprogesterone acetate, megestrol acetate, diethylstilbestrol, ethinyl estradiol, tamoxifen, testosterone propionate, fluoxymesterone, flutamide, leuprolide, acetogenins, e.g., bullatacin, and quassanoids, e.g. simalikalactone D and glaucarubolone, and pharmaceutically acceptable derivatives thereof. 16. The method of claim 1, 2, 10, or 14 in which said administration is made via an implantation device. 17. The method of claim 1, 2, 10, or 14 in which said administration is made with a sustained release formulation. 18. The method of claim 8 in which said administration is made parenterally, orally, or directly into the tumor. 19. The method of claim 1, 2, 10 or 14 wherein said vanilloid is vanillylamine. 20. A dietary or nutritional supplement comprising an effective amount of tea catechins and vanilloids to inhibit and/or treat cancer in a mammal, wherein the ratio of EC to EGCg concentration in said tea catechins is from about 10:1 to about 1000:1. 21. The supplement of claim 20 wherein the ratio of EC to EGCg concentration is about 100:1. 22. The supplement of claim 20 wherein the ratio of EC to EGCg concentration is about 1000:1. 23. The supplement of claim 20 wherein gallic acid has been removed from the composition. 24. The supplement of claim 20 wherein the supplement is a sustained release formulation comprising tea catechins and/or vanilloids and at least one component which controls release of said catechins and/or vanilloids. 25. The supplement of claim 20 wherein the supplement is formulated as an oral preparation comprising tablets or powders. 26. The supplement of claim 20 wherein the supplement is formulated as a sterile preparation. 27. The supplement of claim 20 wherein the supplement is formulated as a parenteral solution. 28. The supplement of claim 20 wherein said vanilloid is vanillylamine. 29. The supplement of claim 20 wherein daily dosage of the catechins is about 10 mg to about 800 mg and daily dosage of the vanilloids is about 0.1 mg to about 80 mg. 30. The supplement of claim 29 wherein daily dosage of the catechins is about 50 mg to about 400 mg and daily dosage of the vanilloids is about 0.05 mg to about 40 mg. 31. A pharmaceutical composition comprising an effective amount of tea catechins and vanilloids to inhibit and/or treat cancer in a mammal, wherein the ratio of EC to EGCg concentration in said tea catechins is from about 10:1 to about 1000:1. 32. The composition of claim 31 wherein the ratio of EC to EGCg concentration is about 100:1. 33. The composition of claim 31 wherein the ratio of EC to EGCg concentration is about 1000:1. 34. The composition of claim 31 wherein gallic acid has been removed from the composition. 35. The composition of claim 31 wherein the composition is a sustained release formulation comprising tea catechins and/or vanilloids and at least one component which controls release of said catechins and/or vanilloids. 36. The composition of claim 31 wherein the composition is formulated as an oral preparation comprising tablets or powders. 37. The composition of claim 31 wherein the composition is formulated as a sterile preparation. 38. The composition of claim 31 wherein the composition is formulated as a parenteral solution. 39. The composition of claim 31 wherein said vanilloids is vanillylamine. 40. The composition of claim 31 wherein daily dosage of the catechins is about 10 mg to about 1000 mg and daily dosage of the vanilloids is about 0.1 mg to about 100 mg. 41. The composition of claim 40 wherein daily dosage of the catechins is about 200 mg to about 600 mg and daily dosage of the vanilloids is about 2 mg to about 60 mg.

Details for Patent 6,759,064

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2021-02-22