Claims for Patent: 9,994,642

Summary for Patent: 9,994,642

Title:	Methods for treating progressive multiple sclerosis
Abstract:	The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.
Inventor(s):	Smith; Craig (Seattle, WA), Chin; Peter S. (San Francisco, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA)
Application Number:	15/597,021
Patent Claims:	1. A method of treating multiple sclerosis in a patient comprising administering an effective amount of an anti-CD20 antibody to the patient to provide an initial antibody exposure of 0.6 grams followed by a second antibody exposure of 0.6 grams, the second exposure not being provided until from 24 weeks or 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody, wherein the anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region. 2. The method of claim 1, wherein the initial antibody exposure comprises a first dose and a second dose of anti-CD20 antibody, wherein the first dose and second dose of anti-CD20 antibody is 0.3 grams. 3. The method of claim 2, wherein the second dose is administered from 3 to 17 days from the time the first dose was administered. 4. The method of claim 2, wherein the second dose is administered from 6 to 16 days from the time the first dose was administered. 5. The method of claim 2, wherein the second dose is administered from 13 to 16 days from the time the first dose was administered. 6. The method of claim 2, wherein the second dose is administered 15 days from the time the first dose was administered. 7. The method of claim 2, wherein the second antibody exposure comprises a single dose of anti-CD20 antibody, wherein the single dose of anti-CD20 antibody is 0.6 grams. 8. The method of claim 1, further comprising providing a third antibody exposure. 9. The method of claim 8, wherein the third anti-CD20 antibody exposure is provided 24 weeks or 6 months from the second exposure. 10. The method of claim 8, further comprising providing a fourth antibody exposure. 11. The method of claim 10, wherein the fourth antibody exposure is provided 24 weeks or 6 months from the third exposure. 12. The method of claim 10, further comprising providing a fifth antibody exposure. 13. The method of claim 12, wherein the fifth antibody exposure is provided 24 weeks or 6 months from the fourth exposure. 14. The method of claim 12, wherein subsequent antibody exposures are administered at intervals of 24 weeks or 6 months. 15. The method of claim 1, wherein a second medicament is administered with the initial exposure or later exposures, wherein the anti-CD20 antibody is the first medicament. 16. The method of claim 15, wherein the second medicament is selected from the group consisting of an interferon, glatiramer acetate, a cytotoxic agent, a chemotherapeutic agent, mitoxantrone, methotrexate, cyclophosphamide, chlorambucil, azathioprine, gamma globulin, Campath, anti-CD4, cladribine, corticosteroid, mycophenolate mofetil (MMF), cyclosporine, a cholesterol-lowering drug of the statin class, estradiol, testosterone; a hormone replacement drug, a TNF inhibitor, a disease-modifying anti-rheumatic drug (DMARD), a non-steroidal anti-inflammatory drug (NSAID), levothyroxine, cyclosporin A, a somatastatin analogue, a cytokine or cytokine receptor antagonist, an anti-metabolite, an immunosuppressive agent, an integrin antagonist or antibody, an LF A-1 antibody, efalizumab, an alpha 4 integrin antibody, natalizumab, and another B-cell surface marker antibody. 17. The method of claim 1, wherein the multiple sclerosis is primary progressive multiple sclerosis (PPMS). 18. The method of claim 1, wherein the multiple sclerosis is relapsing remitting multiple sclerosis (RRMS). 19. The method of claim 1, wherein the subject has never been previously treated with an anti-CD20 antibody. 20. The method of claim 1, wherein the anti-CD20 antibody is administered intravenously. 21. The method of claim 1, wherein anti-CD20 antibody is the only medicament administered to the subject to treat multiple sclerosis. 22. The method of claim 1, wherein the subject has elevated anti-myelin basic protein (MBP), anti-myelin oligodendrocytic glycoprotein (MOG), anti-ganglioside and/or anti-neurofilament antibody levels. 23. The method of claim 1, wherein elevated levels of B cells are present in cerebrospinal fluid (CSF), multiple sclerosis lesion, or serum of the subject. 24. An article of manufacture comprising: (a) a container comprising an anti-CD20 antibody, which anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region; and (b) a package insert with instructions for treating multiple sclerosis in a patient, wherein the instructions indicate that an amount of anti-CD20 antibody is administered to the patient that is effective to provide an initial antibody exposure of 0.6 grams followed by a second antibody exposure of 0.6 grams, the second exposure not being administered until from 24 weeks or 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody. 25. A method of treating multiple sclerosis in a patient comprising administering an effective amount of an anti-CD20 antibody to the patient to provide an initial antibody exposure of about 0.6 grams followed by a second antibody exposure of about 0.6 grams, the second exposure not being provided until from about 6 months from the initial exposure, and each of the antibody exposures is provided to the patient as one or two doses of antibody, wherein the anti-CD20 antibody comprises a VH domain comprising the amino acid set forth in SEQ ID NO: 8, a VL domain comprising the amino acid sequence set forth in SEQ ID NO: 2, and a human IgG1 constant region. 26. The method of claim 25, wherein the initial antibody exposure comprises a first dose and a second dose of anti-CD20 antibody, wherein the first dose and second dose of anti-CD20 antibody about is 0.3 grams.

Details for Patent 9,994,642

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2028-09-16
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2028-09-16
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2028-09-16
Genentech, Inc.	RAPTIVA	efalizumab	Injection	125075	10/27/2003		2028-09-16
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2028-09-16