Use of biologically active vitamin D compounds for the prevention and treatment of inflammatory bowel disease

• US 20020128241A1
• Filed: 12/21/2001
• Published: 09/12/2002
• Est. Priority Date: 12/21/1999
• Status: Active Grant

• 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.
• Granted Patent: US 6,858,595 B2
• Time in Patent Office: Days
• US Class Current: 514/167
• 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: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Methods of treating inflammatory bowel disease are described, and in particular the prevention and treatment of inflammatory bowel disease in humans as well as other animals. These methods involve the administration of biologically active vitamin D compounds, and therapeutic compositions thereof, so that the symptoms of Inflammatory Bowel Disease are reduced or relieved.

Claims

1. A method of treatment, comprising:

a) providing;

i) a subject with symptoms of inflammatory bowel disease, and

ii) a therapeutic composition comprising a biologically active vitamin D compound; and

b) administering said therapeutic composition to said subject under conditions such that said symptoms are reduced.

2. The method of claim 1, wherein said subject is a mammal.

3. The method of claim 1, wherein the subject is selected from a human, non-human primate, horse, dog, and cat.

4. The method of claim 1, wherein said therapeutic composition further comprises a transdermal patch.

5. The method of claim 1, wherein said biologically active vitamin D compound is selected from the group of vitamin D, 1α

,25-(OH)₂-16-ene-D₃, 1α

,25-(OH)₂-24-oxo-16-ene-D₃, 1α

,24R(OH)₂-D₃, 1α

,25(OH)₂-22-oxa-D₃, 20-epi-22-oxa-24a,24b,-dihomo-1α

,25(OH)₂-D₃, 20-epi-22-oxa-24a,26a,27a,-trihomo-1α

,25(OH)₂-D₃, 20-epi-22-oxa-24homo-1α

,25(OH)₂-D₃, 1,25-(OH)₂-16,23E-diene-26-trifluoro-19-nor-D₃.

6. The method of claim 1, wherein said biologically active vitamin D compound is selected from the analogs represented by the following formula:

7. The method of claim 1, wherein said administration is 0.1-20 μ

g per day per 160 pound subject.

8. The method of claim 1, wherein said administration does not cause serious hypercalcemia.

9. The method of claim 1, wherein said administration does not cause symptoms of hypercalcemia.

10. The method of claim 1, wherein the route of administration is selected from intravenously, orally, parenterally, topically, and rectally.

11. The method of claim 1, wherein said biologically active vitamin D compound is administered in a therapeutically effective amount.

12. The method of claim 11, wherein said therapeutically effective amount is the maximum the patient can tolerate without developing serious hypercalcemia.

14. The method of claim 13, wherein said biologically active vitamin D compound is selected from the group of vitamin D, 1α

,25-(OH)₂-16-ene-D₃, 1α

,25-(OH)₂-24-oxo-16 -ene-D₃, 1α

,24R(OH)₂-D₃, 1α

,25(OH)₂-22-oxa-D₃, 20-epi-22-oxa-24a,24b,-dihomo --1,25(OH)₂-D_{31, 20}-epi-22-oxa-24a,26a,27a,-trihomo-1α

,25(OH)₂-D₃, 20-epi-22-oxa -24homo-1α

,25(OH)₂-D₃, 1,25-(OH)₂-16,23E-diene-26-trifluoro-19-nor-D₃.

15. The method of claim 13, wherein said biologically active vitamin D compound is selected from the analogs represented by the following formula:

16. The method of claim 13, wherein said administration delays the onset of symptoms of inflammatory bowel disease.

17. The method of claim 13, wherein said subject at risk for inflammatory bowel disease is a human.

18. The method of claim 17, wherein said human is selected from a young adult, a person living in the United States, a person living in England, a person living in Northern Europe, a person of Jewish descent, a person living in a developing nation, a person with family members who suffer from inflammatory bowel disease or a person determined to carry an IBD risk gene.

19. The method of claim 13, wherein the route of administration is selected from intravenously, orally, parenterally, topically, and rectally.

20. The method of claim 13, wherein said therapeutic composition further comprises a transdermal patch.

13. A method of treatment, comprising:

a) providing;

i) a subject at risk for inflammatory bowel disease, and

ii) a therapeutic composition comprising a biologically active vitamin D compound; and

b) prophylactically administering said therapeutic composition to said subject.