Claims for Patent: 9,132,138

Summary for Patent: 9,132,138

Title:	Method for the treatment of multiple sclerosis
Abstract:	A method for treating a subject with multiple sclerosis is disclosed herein. In one embodiment, a method is provided for treating a subject with multiple sclerosis that includes administering to the subject a therapeutically effective amount of 2ME2 or a derivative thereof.
Inventor(s):	Mak; Tak Wah (Toronto, CA), Duncan; Gordon Stuart (Toronto, CA)
Assignee:	CASI Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	13/789,849
Patent Claims:	1. A method of inhibiting or reducing lymphocyte activation and proliferation in a subject undergoing autoimmune demyelination, which comprises administering to the subject a therapeutically effective amount of a 2ME2 compound having the following formula: ##STR00002## wherein R.sub.a is selected from the group consisting of --OCH.sub.3, --OCH.sub.2CH.sub.3, --CH.sub.3, --CH.sub.2CH.sub.3, --CCCH.sub.3, --CHCH--CH.sub.3, and --CH.sub.2--CHCH.sub.2. 2. The method of claim 1, which further comprises administering to the subject a second agent selected from the group consisting of a steroid, an anti-inflammatory compound, an immunosuppressive compound, and an antioxidant. 3. The method of claim 2, wherein the second agent is beta-interferon. 4. The method of claim 2, wherein the second agent is glatiramer acetate. 5. The method of claim 2, wherein the second agent is lipoic acid. 6. The method of claim 2, wherein the second agent is a monoclonal antibody. 7. The method of claim 2, wherein the second agent is selected from the group consisting of daclizumab, rituximab, and natalizumab. 8. The method of claim 2, wherein the second agent is sanglifehrin A or a compound having cyclophilin D inhibitory activity. 9. The method of claim 1, wherein administration of the 2ME2 compound is oral, parenteral, transdermal, topical, intravenous, subcutaneous, intramuscular, intradermal, ophthalmic, epidural, intratracheal, sublingual, buccal, rectal, vaginal, nasal, or inhalation. 10. A method of inhibiting or reducing NFATc1 nuclear translocation and NFAT-dependent gene transcription in a subject undergoing autoimmune demyelination, which comprises administering to the subject a therapeutically effective amount of a 2ME2 compound having the following formula: ##STR00003## wherein R.sub.a is selected from the group consisting of --OCH.sub.3, --OCH.sub.2CH.sub.3, --CH.sub.3, --CH.sub.2CH.sub.3, --CCCH.sub.3, --CHCH--CH.sub.3, and --CH.sub.2--CHCH.sub.2. 11. The method of claim 10, which further comprises administering to the subject a second agent selected from the group consisting of a steroid, an anti-inflammatory compound, an immunosuppressive compound, and an antioxidant. 12. The method of claim 11, wherein the second agent is beta-interferon. 13. The method of claim 11, wherein the second agent is glatiramer acetate. 14. The method of claim 11, wherein the second agent is lipoic acid. 15. The method of claim 11, wherein the second agent is a monoclonal antibody. 16. The method of claim 11, wherein the second agent is selected from the group consisting of daclizumab, rituximab, and natalizumab. 17. The method of claim 11, wherein the second agent is sanglifehrin A or a compound having cyclophilin D inhibitory activity. 18. The method of claim 10, wherein administration of the 2ME2 compound is oral, parenteral, transdermal, topical, intravenous, subcutaneous, intramuscular, intradermal, ophthalmic, epidural, intratracheal, sublingual, buccal, rectal, vaginal, nasal, or inhalation. 19. A method of inhibiting or reducing T cell cytokine production in a subject undergoing autoimmune demyelination, which comprises administering to the subject a therapeutically effective amount of a 2ME2 compound having the following formula: ##STR00004## wherein R.sub.a is selected from the group consisting of --OCH.sub.3, --OCH.sub.2CH.sub.3, --CH.sub.3, --CH.sub.2CH.sub.3, --CCCH.sub.3, --CHCH--CH.sub.3, and --CH.sub.2--CHCH.sub.2. 20. The method of claim 19, which further comprises administering to the subject a second agent selected from the group consisting of a steroid, an anti-inflammatory compound, an immunosuppressive compound, and an antioxidant. 21. The method of claim 20, wherein the second agent is beta-interferon. 22. The method of claim 20, wherein the second agent is glatiramer acetate. 23. The method of claim 20, wherein the second agent is lipoic acid. 24. The method of claim 20, wherein the second agent is a monoclonal antibody. 25. The method of claim 20, wherein the second agent is selected from the group consisting of daclizumab, rituximab, and natalizumab. 26. The method of claim 20, wherein the second agent is sanglifehrin A or a compound having cyclophilin D inhibitory activity. 27. The method of claim 19, wherein administration of the 2ME2 compound is oral, parenteral, transdermal, topical, intravenous, subcutaneous, intramuscular, intradermal, ophthalmic, epidural, intratracheal, sublingual, buccal, rectal, vaginal, nasal, or inhalation.

Details for Patent 9,132,138

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2039-02-26
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2039-02-26
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/27/2016		2039-02-26
Biogen Inc.	ZINBRYTA	daclizumab	Injection	761029	05/26/2017		2039-02-26