Treatment of immune diseases by oral administration of autoantigens

• US 5,869,093 A
• Filed: 10/24/1994
• Issued: 02/09/1999
• Est. Priority Date: 06/24/1987
• Status: Expired due to Term

• Current Assignee: Bronson Nutritionals LLC (Kabco Pharmaceuticals, Inc.)
• Original Assignee: Autoimmune, Inc.
• Inventors: Weiner, Howard L., Hafler, David A.
• Primary Examiner(s): ACHUTAMURTHY, PONNATHAPURA N
• Application Number:
  US08/328,562
• Time in Patent Office: 1,569 Days
• Field of Search: 530/326, 530/327, 530/328, 530/729, 530/330, 530/350, 530/387.1, 424/184.1, 424/185.1, 424/451, 424/458, 424/463, 424/464, 424/474, 424/489, 514/2, 514/21, 514/825
• US Class Current: 424/451
• CPC Class Codes: A61K 2039/542 oral/gastrointestinal
• CPC Class Codes: A61K 2039/543 intranasal
• CPC Class Codes: A61K 38/1709 from mammals
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61K 39/0008 Antigens related to auto-immune diseases; Preparations to induce self-tolerance
• CPC Class Codes: C07K 14/4713 Autoimmune diseases, e.g. Insulin-dependent diabetes mellitus, multiple sclerosis, rheumathoid arthritis, systemic lupus erythematosus; Autoantigens
• CPC Class Codes: C07K 14/78 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]

Abstract

The invention is directed to a method of treating a T cell-mediated autoimmune disease in animals, including humans, by the oral administration of autoantigens, fragments of autoantigens, or analogs structurally related to those autoantigens, which are specific for the particular autoimmune disease. The method of the invention includes both prophylactic and therapeutic measures.

Claims

1. An oral pharmaceutical dosage form for the treatment of rheumatoid arthritis comprising an effective amount of type II collagen or an autoimmune suppressive fragment thereof and a pharmaceutically acceptable carrier.

2. The oral dosage form of claim 1 comprising an effective amount of type II collagen.

3. The dosage form of claim 1 wherein said effective amount is within the range of about 10 μ

g/day to 100 mg/day.

4. The dosage form of claim 1 wherein said effective amount is within the range of about 100 μ

g/day to 30 mg/day.

5. The dosage form of claim 1 wherein said type II collagen is purified.

6. The dosage form of claim 1 wherein said type II collagen is substantially free of contaminants from its natural source.

7. The dosage form of claim 1 wherein said type II collagen is in a form that is soluble in water.

8. The oral dosage form of claim 1 wherein said effective amount is within the range of about 10 μ

g/day to 100 μ

g/day.

9. The oral dosage form of claim 1 wherein said type II collagen is chicken collagen.

10. The dosage form of claim 1 comprising a solid dosage form.

11. The dosage form of claim 10 wherein said dosage form is a capsule.

12. The dosage form of claim 10 wherein said dosage form is a tablet.

13. The dosage form of claim 1 wherein said collagen is substantially pure.

26. The dosage form of claim 1 comprising a semi-solid dosage form.

27. The dosage form of claim 6 comprising a semi-solid dosage form.

28. The dosage form of claim 7 comprising a semi-solid dosage form.

29. The dosage form of claim 6 comprising a semi-solid dosage form.

14. A solid oral pharmaceutical dosage form for the treatment of rheumatoid arthritis consisting essentially of an effective amount of type II collagen or an autoimmune suppressive fragment thereof and a pharmaceutically acceptable carrier.

15. The dosage form of claim 14 wherein said effective amount is within the range of about 10 μ

g/day to 100 mg/day.

16. The dosage form of claim 14 wherein said effective amount is within the range of about 100 μ

g/day to 30 mg/day.

17. The dosage form of claim 14 wherein said type II collagen is purified.

18. The dosage form of claim 14 wherein said type II collagen is substantially free of contaminants from its natural source.

19. The dosage form of claim 14 wherein said type II collagen is in a form that is soluble in water.

20. The oral dosage form of claim 14 wherein said effective amount is within the range of about 10 μ

g/day to 100 μ

g/day.

21. The oral dosage form of claim 14 wherein said type II collagen is chicken collagen.

22. The dosage form of claim 14 wherein said dosage form is a capsule.

23. The dosage form of claim 14 wherein said dosage form is a tablet.

24. The dosage form of claim 14 wherein said collagen is substantially pure.

25. A solid oral pharmaceutical dosage form for the treatment of rheumatoid arthritis consisting essentially of an effective amount of purified type II collagen and a pharmaceutically acceptable carrier.