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1. WO2007002356 - METHODS AND COMPOSITIONS CONTAINING NATURAL FOLATES FOR PROTECTING AGAINST RADIATION DAMAGE

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6 024415
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WHAT IS CLAIMED IS

1. A method for protecting a subject from harmful effects of ionizing radiation, said method comprising:
administering to the subject an effective amount of at least one reduced folate.

2. A method according to claim 1, wherein the reduced folate is selected from the group consisting of tetrahydrofolic acid, 5-methyl-tetrahydrofolic acid, 5-formyl-tetrahydrofolic acid, 10-formyl-tetrahydrofolic acid, 5,10-methylene-tetrahydrofolic acid, 5 , 10-methenyl-tetrahydrofolic acid, 5-formimino-tetrahydrofolic acid, 7 , 8-dihydrofolic acid, and polyglutamyl derivatives thereof.

3. A method according to claim 1, wherein the reduced folate is selected from the group consisting of (6S) -tetrahydrofolic acid, 5-methyl- (6S) -tetrahydrofolic acid, 5-fortnyl- (6S) -tetrahydrofolic acid, 10-formyl- (6R) -tetrahydrofolic acid, 5 , 10-methylene- (6R) -tetrahydrofolic acid, 5 , 10-methenyl- (6R) -tetrahydrofolic acid, 5-formimino-(6S) -tetrahydrofolic acid, and polyglutamyl derivatives thereof .

4. A method according to claim I1 wherein the reduced folate is selected from the group consisting of racemic tetrahydrofolic acid, racemic 5-methyl-tetrahydrofolic acid, racemic 5-formyl-tetrahydrofolic acid, racemic 10-formyl -tetrahydrofolic acid, racemic 5 , 10-methylene-tetrahydrofolic acid, racemic 5 , 10-methenyl-tetrahydrofolic acid, racemic 5-formimino-tetrahydrofolic acid, and
polyglutamyl derivatives thereof.

5. A method according to claim 1, wherein subject is one who is incurring exposure to a harmful level of
ionizing radiation.

6. A method according to claim 1, wherein subject is one who is at risk for incurring exposure to a harmful level ionizing radiation.

7. A method according to claim 1, wherein the ionizing radiation is gamma radiation.

8. A method according to claim 1, wherein the ionizing radiation is x-ray radiation.

9. A method according to claim 1, wherein the ionizing radiation is cosmic radiation.

10. A method according to claim 1, wherein the reduced folate is administered orally.

11. A method according to claim 1, wherein the reduced folate is administered orally in time-release
formulation.

12. A method according to claim 1, wherein the reduced folate is administered intravenously.

13. A method according to claim 1, wherein the reduced folate is administered in a composition that comprises the reduced folate.

14. A method according to claim 13 , wherein the composition further comprises one or more additional
biologically active materials.

15. A method according to claim 14, wherein the one or more additional biologically active materials comprises a radioprotective agent.

16. A method according to claim 15, wherein the radioprotective agent is an iodide salt.

17. A method according to claim 16, wherein the iodide salt is potassium iodide.

18. A method according to claim 15, wherein the radioprotective agent is a' steroidal radioprotective agent.

19. A method according to claim 18, wherein the steroidal radioprotective agent is an androstenediol .

20. A method according to claim 13, wherein the composition further includes, in addition to the reduced folate, one or more other vitamins.

21. A method according to claim 1, wherein the reduced folate is administered under conditions effective to establish and/or maintain a homeostatic plasma level of reduced folate greater than 20 nanomolar.

22. A method according to claim 1, wherein the reduced folate is administered under conditions effective to establish and/or maintain a homeostatic plasma level of reduced folate greater than about 30 nanomolar.

23. A method according to claim 1, wherein the reduced folate is administered at a daily dose of from about 0.45 micromoles to about 15 micromoles.

24. A method according to claim 1, wherein the reduced folate is administered in a dose containing from about 0.45 micromoles to about 2 millimoles.

25. A radioprotective composition comprising:
a fist radioprotective agent, said first radioprotective agent being a reduced folate; and
a second radioprotective agent.

26. A radioprotective composition according to claim 25, wherein the reduced folate is selected from the group consisting of tetrahydrofolic acid, 5-methyl-tetrahydrofolic acid, 5-formyl-tetrahydrofolic acid, 10-formyl-tetrahydrofolic acid, 5 , 10-methylene-tetrahydrofolic acid, 5 , 10-methenyl-tetrahydrofolic acid, 5-formimino-tetrahydrofolic acid, 7 , 8-dihydrofolic acid, and polyglutamyl derivatives thereof.

27. A radioprotective composition according to claim 25, wherein the reduced folate is selected from the group consisting of (6S) -tetrahydrofolic acid, 5-methyl- (6S) -tetrahydrofolic acid, 5-formyl- (6S) -tetrahydrofolic acid, 10-formyl- (6R) -tetrahydrofolic acid, 5 , 10 -methylene- (6R) -tetrahydrofolic acid, 5 , 10-methenyl- (6R) -tetrahydrofolic acid, 5-formimino- (6S) -tetrahydrofolic acid, and polyglutamyl derivatives thereof.

28. A radioprotective composition according to claim 25, wherein the reduced folate is selected from the group consisting of racemic tetrahydrofolic acid, racemic 5-methyl-tetrahydrofolic acid, racemic 5-fόrmyl-tetrahydrofolic acid, racemic 10-formyl-tetrahydrofolic acid, racemic 5,10-methylene-tetrahydrofolic acid, racemic 5 , 10-methenyl- tetrahydrofolic acid, racemic 5-formimino-tetrahydrofolic acid, and polyglutamyl derivatives thereof.

29. A radioprotective composition according to claim 25, wherein the second radioprotective agent is an iodide salt .

30. A radioprotective composition according to claim 29, wherein the iodide salt is potassium iodide.

31. A radioprotective composition according to claim 25, wherein the second radioprotective agent is a steroidal radioprotective agent.

32. A radioprotective composition according to claim 31, wherein the steroidal radioprotective agent is an androstenediol .

33. A radioprotective composition according to claim 25, wherein the composition is substantially free from vitamin B12.

34. A radioprotective composition according to claim 25, wherein the composition comprises from about 0.45 micromoles to about 2 millimoles of reduced folate.

35. A radioprotective composition according to claim 25, wherein the second radioprotective agent is
potassium iodide and wherein the composition comprises from about 1 milligram to about 500 milligrams of potassium iodide,

36. A radioprotective composition according to claim 35, wherein the composition comprises from about 0.45 micromoles to about 2 millimoles of reduced folate.

37. A method for protecting a subject from harmful effects of ultraviolet radiation, said method comprising:
administering to the subject a composition
comprising an effective amount of at least one reduced folate, wherein said composition is substantially free from vitamin B12.

38. A method according to claim 37, wherein the reduced folate is selected from the group consisting of tetrahydrofolic acid, 5-methyl -tetrahydrofolic acid, 5-formyl-tetrahydrofolic acid, 10-formyl-tetrahydrofolic acid, 5,10-methylene-tetrahydrofolic acid, 5 , 10 -methenyl-tetrahydrofolic acid, 5-formimino-tetrahydrofolic acid, 7 , 8-dihydrofolic acid, and polyglutamyl derivatives thereof.

39. A method according to claim 37, wherein the reduced folate is selected from the group consisting of (6S) -tetrahydrofolic acid, 5-methyl- (6S) -tetrahydrofolic acid, 5-formyl- (6S) -tetrahydrofolic acid, 10-formyl- (6R) -tetrahydrofolic acid, 5, 10 -methylene- (6R) -tetrahydrofolic acid, 5 , 10-methenyl- (6R) -tetrahydrofolic acid, 5-formimino- (6S) -tetrahydrofolic acid, and polyglutamyl derivatives thereof .

40. A method according to claim 37, wherein the reduced folate is selected from the group consisting of racemic tetrahydrofolic acid, racemic 5-methyl -tetrahydrofolic acid, racemic 5-formyl-tetrahydrofolic acid, racemic 10-formyl-tetrahydrofolic acid, racemic 5 , 10-methylene-tetrahydrofolic acid, racemic 5 , 10-methenyl-tetrahydrofolic acid, racemic 5-formimino-tetrahydrofolic acid, and
polyglutamyl derivatives thereof .

41. A method according to claim 37, wherein said composition comprises no vitamin B12 or wherein said
composition comprises vitamin B12 in an amount that is equal to or less than 300% of the recommended daily allowance of vitamin B12 for the subject.

42. A method according to claim 37, wherein said composition comprises no vitamin B12 or wherein said
composition comprises vitamin B12 in an amount that is equal to or less than 200% of the recommended daily allowance of vitamin B12 for the subject.

43. A method according to claim 37, wherein said composition comprises no vitamin B12 or wherein said
composition comprises vitamin B12 in an amount that is equal to or less than the recommended daily allowance of vitamin B12 for the subject.

44. A method according to claim 37, wherein the composition is administered orally.

45. A method according to claim 37, wherein the composition is administered topically.

46. A method according to claim 37, wherein the composition is a time-release composition and wherein the composition is administered orally.