Claims for Patent: 8,501,717

Summary for Patent: 8,501,717

Title:	Methods to treat and/or prevent mucositis
Abstract:	The present invention relates to methods useful for treating and/or preventing mucositis using an active vitamin D compound.
Inventor(s):	Zong; Chen (Metuchen, NJ)
Assignee:	Merck, Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	12/524,683
Patent Claims:	1. A method for treating oral mucositis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an active vitamin D compound. 2. The method of claim 1, wherein the active vitamin D compound is selected from the group consisting of calcitriol, 1.alpha.-cacidol and calcifediol. 3. The method of claim 1, wherein the active vitamin D compound is calcitriol. 4. The method of claim 1, wherein the active vitamin D compound is administered by high pulse dose administration. 5. The method of claim 4, wherein the high dose pulse administration is administered no more frequently than once in three days. 6. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to reach supraphysiologic levels without inducing severe symptomatic hypercalcemia. 7. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to reach blood plasma levels greater than about 0.25 nM. 8. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to reach blood plasma levels equal to or greater than 1 nM. 9. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to reach blood plasma levels equal to or greater than 1 nM within 2 to 36 hours after administration. 10. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to maintain the subject's plasma level of the active vitamin D compound at or above 1 nM for 24 hours. 11. The method of claim 1, wherein the active vitamin D compound is administered in an amount sufficient to achieve an area under the curve concentration of equal to or greater than 24 nMhour. 12. The method of claim 1, wherein the active vitamin D compound is administered at a dose of about 15 .mu.g to about 1 mg. 13. The method of claim 1, wherein the active vitamin D compound is administered at a dose of about 15 .mu.g to 60 .mu.g. 14. The method of claim 1, wherein the active vitamin D compound is administered at a dose of about 30 .mu.g to 60 .mu.g. 15. The method of claim 1, wherein the active vitamin D compound is administered at a dose of about 45 .mu.g. 16. The method of claim 1, wherein the subject in need thereof is a cancer patient. 17. The method of claim 16, wherein the subject in need thereof does not have androgen induced prostate cancer. 18. The method of claim 1, wherein the mucositis is caused by radiation-induced toxicity in non-malignant tissue. 19. The method of claim 1, wherein the mucositis is caused by chemical-induced toxicity in non-malignant tissue. 20. The method of claim 19, wherein the chemical-induced toxicity is not caused by docetaxel. 21. The method of claim 1, wherein the active vitamin D compound is administered as a unit dosage form comprising about 10 .mu.g to about 75 .mu.g of calcitriol, about 50% MIGLYOL 812 and about 50% tocopherol peg-1000 succinate. 22. The method of claim 21, wherein the active vitamin D compound is administered as a unit dosage form comprising about 45 .mu.g of calcitriol, about 50% MIGLYOL 812 and about 50% tocopherol peg-1000 tocopherol. 23. The method of claim 21, wherein the active vitamin D compound is administered as a unit dosage form comprising about 15 .mu.g of calcitriol, about 50% MIGLYOL 812 and about 50% tocopherol peg-1000 tocopherol. 24. The method of claim 22 wherein the unit dosage form further comprises butylated hydroxyanisole and butylated hydroxytoluene. 25. The method of claim 23 wherein the unit dosage form further comprises butylated hydroxyanisole and butylated hydroxytoluene. 26. The method of claim 1, wherein the active vitamin D compound is administered orally, intravenously, parenterally, rectally, sublingually, intramuscularly, topically, nasally or transdermally. 27. The method of claim 26, wherein the active vitamin D compound is administered orally. 28. The method of claim 26, wherein the active vitamin D compound is administered intravenously. 29. The method of claim 1, wherein the active vitamin D compound is administered in combination with radiation therapy. 30. The method of claim 1, wherein the active vitamin D compound is administered in combination with chemotherapy. 31. The method of claim 1, wherein the active vitamin D compound is administered in combination with one or more therapeutic agents. 32. The method of claim 31, wherein the active vitamin D compound is administered in combination with a protease activated receptor-1 inhibitor. 33. The method of claim 31, wherein the active vitamin D compound is administered in combination with an agent selected from the group consisting of: a PAR-1 inhibitor, palifermin, glutamine, L-glutamine, teduglutide, sucralfate mouth rinses, iseganan, lactoferrin, mesna, trefoil factor, and CASAD; or a combination of two or more of the above.

Details for Patent 8,501,717

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KEPIVANCE	palifermin	For Injection	125103	12/15/2004		2027-02-09