Prevention of ovarian cancer by administration of a Vitamin D compound

• US 7,053,074 B2
• Filed: 01/18/2002
• Issued: 05/30/2006
• Est. Priority Date: 09/13/1996
• Status: Expired due to Fees

• Current Assignee: New Life Pharmaceuticals Incorporated
• Original Assignee: New Life Pharmaceuticals Incorporated
• Inventors: Rodriguez, Gustavo C., Whitaker, Regina Salas
• Primary Examiner(s): Cook, Rebecca
• Application Number:
  US10/051,662
• Publication Number:
  US 20020061867A1
• Time in Patent Office: 1,593 Days
• Field of Search: 514/167, 514/171, 514/181
• US Class Current: 514/167
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61K 31/593 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3

Abstract

The present invention relates to methods for preventing the development of epithelial ovarian cancer by administering a Vitamin D compound in an amount capable of increasing apoptosis in non-neoplastic ovarian epithelial cells of the female subject.

Claims

1. A pharmaceutical combination comprising 28 daily sequential dosages, said product including 21 sequential daily hormone dosages, with each hormone dosage comprising a progestin product and an estrogen product and with at least one of said hormone dosages further comprising a Vitamin D compound, and said product further including 7 other daily dosages that do not contain either estrogen and/or progestin and wherein said product is adapted for administration of said Vitamin D compound on a less frequently than daily basis.

2. The combination of claim 1 wherein the Vitamin D compound is 1,25 (OH)2 Vitamin D₃ (calcitriol).

3. The combination of claim 1 wherein the Vitamin D compound is Vitamin D₃ (cholecalciferol).

4. The combination of claim 1 wherein said the estrogen product is ethinyl estradiol.

5. The combination of claim 4 wherein the daily dosage of said ethinyl estradiol is less than or equal to 0.050 mg and greater than or equal to 0.020 mg.

6. The combination of claim 1 wherein the dosage of said Vitamin D compound in at least one of said hormone dosages is equivalent to at least 400 I.U.

7. The combination of claim 6 wherein the dosage of said Vitamin D compound in at least one of said hormone dosages is equivalent to at least 2000 I.U.

8. The combination of claim 7 wherein the dosage of said Vitamin D compound in at least one of said hormone dosages is equivalent to at least 4000 I.U.

9. The combination of claim 1 wherein said product is adapted for daily administration of said Vitamin D compound with each said daily hormone dosage.

10. The combination of claim 1 wherein said product is adapted for administration of said Vitamin D compound on a less frequently than daily basis.

11. The combination of claim 1 wherein said progestin product is a gonane.

12. The combination of claim 1 wherein said progestin product is a pregnane.

13. The combination of claim 1 wherein said progestin product is a estrane.

14. The combination of claim 1 wherein said progestin product is norgestimate.

15. The combination of claim 14 wherein said the estrogen product is ethinyl estradiol and the daily dosage of said ethinyl estradiol is less than or equal to 0.035 mg and greater than or equal to 0.020 mg.

16. The combination of claim 1 wherein at least one Vitamin D compound is in a single unit dosage with one dosage of said progestin product.

17. A pharmaceutical combination comprising 21 sequential daily dosages, said 21 daily dosages comprising a progestin product and/or an estrogen product, with at least one of said daily dosages further comprising a Vitamin D compound that does not have hydroxylation at both the 1 and 25 positions and wherein said product is adapted for administration of said Vitamin D compound on a less frequently than daily basis.

18. The combination of claim 17 wherein said Vitamin D compound is Vitamin D₂ (ergocalciferol).

19. The combination of claim 18 wherein the Vitamin D compound is Vitamin D₃ (cholecalciferol).

20. The combination of claim 19 wherein the dosage of said Vitamin D compound is equivalent to at least 400 I.U.

21. The combination of claim 17 wherein the dosage of said Vitamin D compound is equivalent to at least 2000 I.U.

22. The combination of claim 17 wherein the dosage of said Vitamin D compound is equivalent to at least 4000 I.U.

23. The combination of claim 17 wherein said product is adapted for daily administration of said Vitamin D compound with each daily hormone dosage.

24. The combination of claim 17 wherein said product is adapted for administration of said Vitamin D compound on a less frequently than daily basis.

25. The combination of claim 17 wherein said estrogen product is conjugated equine estrogen.

26. The combination of claim 20 wherein the dosage of said conjugated equine estrogen 0.625 mg.

27. The combination of claim 17 wherein said estrogen product is estrodiol.

28. The combination of claim 17 wherein the daily dosage equivalent of said progestin product is less than or equal to 10 mg of norethindrone.

29. The combination of claim 17 wherein the daily dosage equivalent of said progestin product is less than or equal to 2.5 mg of medroxyprogesterone acetate daily.

30. The combination of claim 17 wherein said Vitamin D compound is in a single unit dosage with said progestin product and/or estrogen product.

31. A pharmaceutical combination comprising 21 sequential daily dosages, said 21 daily dosages comprising a progestin product and/or an estrogen product, with at least one of said daily dosages further comprising a Vitamin D compound, and wherein said product is adapted for administration of said Vitamin D compound on a less frequently than daily basis.

32. The combination of claim 31 wherein said Vitamin D compound is Vitamin D₂ (ergocalciferol).

33. The combination of claim 31 wherein the Vitamin D compound is Vitamin D₃ (cholecalciferol).

34. The combination of claim 31 wherein said Vitamin D compound is calcitriol.

35. The combination of claim 31 wherein the dosage of said Vitamin D compound is equivalent to at least 400 I.U.

36. The combination of claim 31 wherein the dosage of said Vitamin D compound is equivalent to at least 2000 I.U.

37. The combination of claim 31 wherein the dosage of said Vitamin D compound is equivalent to at least 4000 I.U.

38. The combination of claim 31 wherein said progestin product is a gonane.

39. The combination of claim 31 wherein said progestin product is an estrane.

40. The combination of claim 31 wherein said progestin product is a progesterone.

41. The combination of claim 31 wherein said the estrogen product is conjugated equine estrogen.

42. The combination of claim 31 wherein the dosage of said conjugated equine estrogen is 0.625 mg.

43. The combination of claim 31 wherein said estrogen product is estradiol.

44. The combination of claim 31 wherein the daily dosage equivalent of said progestin product is less than or equal to 10 mg of norethindrone.

45. The combination of claim 31 wherein the daily dosage equivalent of said progestin product is less than or equal to 2.5 mg of medroxyprogesterone acetate daily.