Treating vitamin D responsive diseases

• US 6,989,377 B2
• Filed: 06/13/2002
• Issued: 01/24/2006
• Est. Priority Date: 12/21/1999
• Status: Expired due to Fees

• Current Assignee: Wisconsin Alumni Research Foundation (University of Wisconsin System)
• Original Assignee: Wisconsin Alumni Research Foundation (University of Wisconsin System)
• Inventors: Nashold, Faye E., Hayes, Colleen E.
• Primary Examiner(s): QAZI, SABIHA NAIM
• Application Number:
  US10/170,746
• Publication Number:
  US 20030109506A1
• Time in Patent Office: 1,321 Days
• Field of Search: 514/167, 552/653
• 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 31/59 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
• CPC Class Codes: A61K 38/2066 IL-10
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Abstract

The present invention relates to therapeutics for the prevention and treatment of vitamin D responsive diseases in humans, as well as other animals, through the use of biologically active vitamin D compounds in combination with at least one other immunomodulatory compound such as interleukin-10, interleukin-4, or a TNFα inhibitor.

Claims

1. A method of treatment, comprising:

administering a therapeutically effective amount of a biologically active vitamin D compound selected from 1,25-dihydroxyvitamin D₃ or 1α

-hvdroxyvitamin D₃, and a therapeutically effective amount of interleukin-10 to a subject with symptoms of a vitamin D responsive disease, wherein said vitamin D responsive disease is selected from the group consisting of osteoporosis, renal osteodystrophy, psoriasis, multiple sclerosis, arthritis, ulcerative colitis, and Crohn'"'"'s disease.

2. The method of claim 1, wherein said administration does not cause severe or moderate hypercalcemia.

3. The method of claim 1, further comprising determining if said subject is an IL-10 deficient subject.

4. The method of claim 1, wherein said at least one vitamin D responsive disease is selected from the group consisting of osteoporosis, renal osteodystrophy, psoriasis, multiple sclerosis, and arthritis.

5. The method of claim 1, wherein said vitamin D responsive disease is ulcerative colitis or Crohn'"'"'s disease.

6. The method of claim 1, wherein said interleukin-10 is human.

7. The method of claim 1, wherein said interleukin-10 is recombinant.

8. The method of claim 1, wherein said biologically active vitamin D compound is 1,25-dihydroxyvitamin D₃.

9. The method of claim 1, wherein said biologically active vitamin D compound is 1α

-hydroxyvitamin D₃.

10. The method of claim 1, wherein said administering is via a transdermal patch.

11. The method of claim 1, wherein said therapeutically effective amount of said biologically active vitamin D compound comprises a daily dose of at least 5 μ

g per day.

12. The method of claim 1, wherein said therapeutically effective amount of said interleukin-10 comprises a daily dose of approximately 4-6 μ

g per kilogram of said subject per day.

13. A composition comprising a first amount of a biologically active vitamin D compound selected from 1,25-dihydroxyvitamin D₃ or 1α

-hydroxyvitamin D₃, and a second amount of interleukin-10, wherein said first amount is between 0.01 μ

g and 50 μ

g, and wherein said second amount is between 25 μ

g and 500 μ

g.

14. The composition of claim 13, wherein said first amount is between 0.1 μ

g and 25 μ

g.

15. The composition of claim 13, wherein said second amount is between 175 μ

g-400 μ

g.

16. The composition of claim 13, wherein said second amount is between 250 μ

g-350 μ

g.

17. The composition of claim 13, wherein said interleukin-10 is human.

18. The composition of claim 13, wherein said interleukin-10 is recombinant.

19. The composition of claim 13, wherein said biologically active vitamin D compound is 1,25-dihydroxyvitamin D₃.

20. The composition of claim 13, wherein said biologically active vitamin D compound is 1α

-hydroxyvitamin D₃.