Claims for Patent: 8,105,611

Summary for Patent: 8,105,611

Title:	Treatment of autoimmune disorder with a neurotoxin
Abstract:	Methods of treating one or more autoimmune disorders include a step of administering a Clostridial neurotoxin, such as a botulinum toxin, to a patient that has an autoimmune disorder. In one aspect, a method includes a step of administering the neurotoxin to the thymus gland or near the thymus gland of the patient. In another aspect, a method includes a step of administering the neurotoxin in combination with administering a cytokine inhibitor to the patient. Compositions are also described.
Inventor(s):	Tong; Kenneth L. (Carlsbad, CA), Van Schaack; Pamela D. (Costa Mesa, CA)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	11/156,502
Patent Claims:	1. A method for treating a non-arthritic autoimmune disorder in a patient in need thereof, the method comprising: administering an effective amount of a Clostridial neurotoxin to a location in proximity to the thymus gland of a patient to alleviate at least one symptom of the non-arthritic autoimmune disorder, thereby treating the non-arthritic autoimmune disorder; wherein the effective amount of a botulinum toxin is that amount which causes alleviation of a symptom of the non-arthritic autoimmune disorder without systemic toxicity resulting. 2. The method of claim 1, wherein the Clostridial neurotoxin is administered to a location containing cholinergic neurons innervating the thymus gland. 3. The method of claim 1, wherein the Clostridial neurotoxin is administered directly to the thymus gland. 4. The method of claim 1, wherein the Clostridial neurotoxin is selected from the group consisting of botulinum toxins types A, B, C.sub.1, D, E, F, and G. 5. The method of claim 1, wherein the Clostridial neurotoxin is botulinum toxin type A. 6. The method of claim 1, wherein the botulinum toxin administered is a botulinum toxin type A in an amount from no less than about 1 unit and no more than about 50 units of a botulinum toxin type A per injection site per patient treatment session. 7. The method of claim 1, wherein the botulinum toxin administered is a botulinum toxin type A in an amount from no less than about 2 unit and no more than about 200 units of a botulinum toxin type A per injection site per patient treatment session. 8. The method of claim 1, wherein the botulinum toxin administered is a botulinum toxin type B in an amount from no less than about 40 unit and no more than about 2500 units of a botulinum toxin type B per injection site per patient treatment session. 9. The method of claim 1, wherein the administering comprises a step selected from the group consisting of injecting a composition comprising a botulinum toxin component and a carrier component into the patient, and placing an implant device comprising a botulinum toxin into the patient. 10. The method of claim 1, further comprising administering a cytokine inhibitor to the patient in an amount effective to alleviate at least one symptom of the non-arthritic autoimmune disorder. 11. The method of claim 1, wherein the non-arthritic autoimmune disorder is selected from the group consisting of scleroderma or CREST syndrome, Sjogren's syndrome, Goodpasture's syndrome, Wegener's granulomatosis, temporal arteritis/giant cell arteritis, Type 1 Diabetes Mellitus, Hashimoto's thyroiditis, Graves' disease, celiac disease, Crohn's diseases, ulcerative colitis, multiple sclerosis, Guillain-Barre syndrome, Addison's disease, primary biliary sclerosis, sclerosing cholangitis, autoimmune hepatitis, Raynaud's phenomenon, pernicious anemia, Addison's disease, dermatomyositis, myasthenia gravis, Pemphigus vulgaris, autoimmune hemolytic anemia, autoimmune thrombocytopenic purpura, vasculitis, and amyotrophic lateral schierosis. 12. A method for treating a non-arthritic autoimmune disorder in a patient in need thereof, the method comprising: administering an effective amount of a Clostridial neurotoxin and an effective amount of a cytokine inhibitor to a patient to alleviate at least one symptom of the non-arthritic autoimmune disorder, thereby treating the non-arthritic autoimmune disorder; wherein the effective amount of a botulinum toxin is that amount which causes alleviation of a symptom of the non-arthritic autoimmune disorder without a systemic toxicity resulting. 13. The method of claim 12, wherein the Clostridial neurotoxin and cytokine inhibitor are administered in amounts that provide a greater relief of the at least one symptom of the non-arthritic autoimmune disorder compared to the administration of only the Clostridial neurotoxin or the cytokine inhibitor alone to a patient to treat the same non-arthritic autoimmune disorder. 14. The method of claim 12, wherein the Clostridial neurotoxin is selected from the group consisting of botulinum toxins types A, B, C.sub.1, D, E, F, and G. 15. The method of claim 12, wherein the Clostridial neurotoxin is botulinum toxin type A. 16. The method of claim 12, wherein the botulinum toxin administered is a botulinum toxin type A in an amount from no less than about 1 unit and no more than about 50 units of a botulinum toxin type A per injection site per patient treatment session. 17. The method of claim 12, wherein the botulinum toxin administered is botulinum toxin type A in an amount from no less than about 2 unit and no more than about 200 units of a botulinum toxin type A per injection site per patient treatment session. 18. The method of claim 12, wherein the botulinum toxin administered is a botulinum toxin type B in an amount from no less than about 40 unit and no more than about 2500 units of a botulinum toxin type B per injection site per patient treatment session. 19. The method of claim 12, wherein the Clostridial neurotoxin and the cytokine inhibitor are administered to the patient in a single composition. 20. The method of claim 12, wherein the Clostridial neurotoxin is administered to the thymus gland of the patient. 21. The method of claim 12, wherein the Clostridial neurotoxin is botulinum toxin type A and the cytokine inhibitor is selected from the group consisting of cytokine neutralizers, cytokine receptor blockers, anti-inflammatory cytokines, and combinations thereof. 22. The method of claim 12, wherein the Clostridial neurotoxin is administered in an amount effective in inhibiting neuropeptide mediated inflammation, and the cytokine inhibitor is administered in an amount effective in inhibiting cytokine mediated inflammation. 23. The method of claim 1, wherein the non-arthritic autoimmune disorder is a systemic non-arthritic autoimmune disease. 24. The method of claim 1, wherein the non-arthritic autoimmune disorder is a localized non-arthritic autoimmune disease. 25. The method of claim 12, wherein the non-arthritic autoimmune disorder is selected from the group consisting of scleroderma or CREST syndrome, Sjogren's syndrome, Goodpasture's syndrome, Wegener's granulomatosis, temporal arteritis/giant cell arteritis, Type 1 Diabetes Mellitus, Hashimoto's thyroiditis, Graves' disease, celiac disease, Crohn's diseases, ulcerative colitis, multiple sclerosis, Guillain-Barre syndrome, Addison's disease, primary biliary sclerosis, sclerosing cholangitis, autoimmune hepatitis, Raynaud's phenomenon, pernicious anemia, Addison's disease, dermatomyositis, myasthenia gravis, Pemphigus vulgaris, autoimmune hemolytic anemia, autoimmune thrombocytopenic purpura, vasculitis, and amyotrophic lateral schlerosis. 26. The method of claim 12, wherein the non-arthritic autoimmune disorder is a systemic non-arthritic autoimmune disease. 27. The method of claim 12, wherein the non-arthritic autoimmune disorder is a localized non-arthritic autoimmune disease.

Details for Patent 8,105,611

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	12/08/2000		2039-02-26