Claims for Patent: 9,498,528

Summary for Patent: 9,498,528

Title:	Treatment of multiple sclerosis (MS)
Abstract:	A method for treatment of multiple sclerosis (MS) with Campath-1H with significant efficacy and a favorable safety profile is described, which offers an acceptable benefit/risk ratio. Especially described is the use of Campath-1H (alemtuzumab) for the production of a medicament for the treatment of multiple sclerosis (MS), comprising a first treatment cycle followed by at least one further treatment cycle of Campath-1H (alemtuzumab), in which each treatment cycle comprises 1-5 daily doses which are applied on consecutive days, wherein the daily dose is >0 and .ltoreq.12 mg, and wherein each treatment cycle is separated from the next cycle by at least 1-24 months. Also described are treatment regimens comprising the administration of less than 12 mg/day of Campath-1H for a period of 1-5 consecutive days.
Inventor(s):	Margolin; David H. (Somerville, MA), Hong; Walter (Whippany, NJ), Coles; Alasdair J. (Cambridge, GB), Compston; Alastair (Cambridge, GB), Shaked; Ze\'ev (San Antonio, TX)
Assignee:	GENZYME CORPORATION (Cambridge, MA) ALCAFLEU MANAGEMENT GMBH & CO. KG. (Ot Waltersdorf, DE)
Application Number:	11/900,211
Patent Claims:	1. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, the method comprising: administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in an initial treatment cycle, and at least 3 months after the initial treatment cycle, administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in a second treatment cycle. 2. The method of claim 1, wherein the anti-CD52 antibody is administered to the patient at 12 mg/day in the initial treatment cycle and in the second treatment cycle. 3. The method of claim 1 or 2, wherein the anti-CD52 antibody is administered to the patient for five consecutive days in the initial treatment cycle and three consecutive days in the second treatment cycle. 4. The method of claim 1, wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 12 months. 5. The method of claim 1, wherein the patient has no renewed MS activity for at least 12 months after the second treatment cycle. 6. The method of claim 1, wherein the 1-12 mg of the anti-CD52 antibody for each treatment day is administered to the patient via intravenous infusion. 7. The method of claim 1, wherein the patient is pre-medicated with a steroid immediately prior to the anti-CD52 antibody administration on the first three days of each treatment cycle. 8. The method of claim 7, wherein the steroid is methylprednisolone. 9. The method of claim 1, wherein the anti-CD52 antibody is administered to the patient at less than 12 mg/day in the initial treatment cycle and in the second treatment cycle. 10. The method of claim 1, wherein the patient is treated with acetaminophen or an antihistamine before, during or after treatment with the anti-CD52 antibody. 11. The method of claim 1, further comprising administering the anti-CD52 antibody at 1-12 mg/day for 1-5 days in one or more subsequent treatment cycles after the second treatment cycle, if the patient has renewed MS activity after the second treatment cycle. 12. The method of claim 1 or 2, wherein the anti-CD52 antibody is alemtuzumab. 13. The method of claim 1, wherein the patient has previously been treated with an MS drug that is not an anti-CD52 antibody. 14. The method of claim 13, wherein the patient has failed to respond to the previous MS treatment. 15. The method of claim 1, wherein the patient has a relapsing form of MS. 16. The method of claim 15, wherein the patient has relapsing-remitting MS. 17. The method of claim 15, wherein the patient has active relapsing MS. 18. The method of claim 1, wherein the patient is treated with a steroid before or during treatment with the anti-CD52 antibody. 19. The method of claim 1, wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 6 months. 20. The method of claim 1, wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 18 months. 21. The method of claim 1, wherein the period of time between the initial treatment cycle and the second treatment cycle is at least 24 months. 22. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of alemtuzumab, the method comprising: administering alemtuzumab to the patient at 12 mg/day for five consecutive days in an initial treatment cycle, and 12 months after the initial treatment cycle, administering alemtuzumab to the patient at 12 mg/day for three consecutive days in a second treatment cycle. 23. The method of claim 22, wherein the 12 mg of alemtuzumab for each treatment day is administered to the patient via intravenous infusion. 24. The method of claim 22, wherein the patient is pre-medicated with a steroid immediately prior to alemtuzumab administration for the first three days of each treatment cycle. 25. The method of claim 22, wherein the patient has a relapsing form of MS. 26. A method of reducing the risk of relapse, or the risk of progression of clinically significant disability, in a multiple sclerosis (MS) patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, the method comprising: administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in an initial treatment cycle, and at least 3 months after the initial treatment cycle, administering the anti-CD52 antibody to the patient at 1-12 mg/day for 1-5 days in a second treatment cycle. 27. The method of claim 26, wherein the anti-CD52 antibody is alemtuzumab. 28. The method of claim 26, wherein the patient has a relapsing form of MS. 29. A method of treating multiple sclerosis (MS) in a patient with a single MS immunotherapeutic consisting of an anti-CD52 antibody, wherein the method comprises: administering a total dose of 10-60 mg of the anti-CD52 antibody to the patient over 1-5 days in an initial treatment cycle, and at least 3 months after the initial treatment cycle, administering a total dose of 10-60 mg of the anti-CD52 antibody to the patient over 1-5 days in a second treatment cycle. 30. The method of claim 29, wherein the anti-CD52 antibody is alemtuzumab. 31. The method of claim 29, wherein the patient has a relapsing form of MS. 32. The method of claim 22, 26, or 29, wherein the patient has previously been treated with an MS drug that is not an anti-CD52 antibody. 33. The method of claim 32, wherein the patient has failed to respond to the previous MS treatment. 34. The method of claim 22, 26, or 29, wherein the patient has not received prior MS therapy. 35. The method of claim 26 or 29, wherein the second treatment cycle is administered at least 12 months after the first treatment cycle. 36. The method of claim 22, 26, or 29, wherein the patient is treated with a steroid to manage infusion-related side effects. 37. The method of claim 1, 22, 26, or 29, wherein the two treatment cycles stabilize or decrease progression of neurological disability. 38. The method of claim 1, 22, 26, or 29, wherein the two treatment cycles stabilize or reduce central nervous system lesions as detected by imaging. 39. The method of claim 22, 26, or 29, further comprising administering the anti-CD52 antibody at 1-12 mg/day for 1-5 days in a further treatment cycle in response to renewed MS activity. 40. The method of claim 1, 22, 26, or 29, wherein the anti-CD52 antibody is administered to the patient in only the initial and second treatment cycles. 41. A method of treating a relapsing form of multiple sclerosis (MS) in a patient, the method comprising: administering alemtuzumab to the patient at 12 mg/day for five consecutive days in an initial treatment cycle, and 12 months after the initial treatment cycle, administering alemtuzumab to the patient at 12 mg/day for three consecutive days in a second treatment cycle, wherein the 12 mg of alemtuzumab for each treatment day is administered to the patient via intravenous infusion over a period of 4 hours, and wherein the patient is pre-medicated with a steroid immediately prior to alemtuzumab administration for the first three days of each treatment cycle. 42. The method of claim 41, wherein the method produces a therapeutic effect within the treated patient that is sustained for at least 12 months after the second treatment cycle and the therapeutic effect is a reduction in the risk of relapse. 43. The method of claim 41, wherein the method produces a therapeutic effect within the treated patient that is sustained for at least 12 months after the second treatment cycle and the therapeutic effect is a reduction in the risk for progression of clinically significant disability. 44. The method of claim 41, wherein the steroid is methylprednisolone and is administered to the patient at 1 g/day intravenously. 45. The method of claim 41, wherein the patient is treated with acetaminophen or an antihistamine before, during or after treatment with alemtuzumab.

Details for Patent 9,498,528

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2026-09-13
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2026-09-13
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2026-09-13