Claims for Patent: 9,617,343

Summary for Patent: 9,617,343

Title:	Methods and compositions for treating lupus
Abstract:	The invention provides methods of treating lupus in a patient with an anti-CD52 antibody. Also includes are methods of increasing infiltration of regulatory T cells to affected sides of the patient\'s body, methods of reducing urine protein and/or albumin levels and methods of depleting lymphocytes to alleviate lupus symptoms.
Inventor(s):	Kaplan; Johanne M. (Sherborn, MA), Roberts; Bruce L. (Southborough, MA), Siders; William M. (Franklin, MA)
Assignee:	GENZYME CORPORATION (Cambridge, MA)
Application Number:	13/320,001
Patent Claims:	1. A method of increasing FoxP3.sup.+ regulatory T cells in a patient with lupus, comprising selecting a patient for treatment for lupus, and administering to the patient in vivo antibody therapy consisting of administration of an anti-CD52 monoclonal antibody, wherein the anti-CD52 monoclonal antibody increases FoxP3.sup.+ regulatory T cells in the patient, wherein the method does not include ex vivo expansion of T cells to produce regulatory T cells, thereby treating lupus in the patient. 2. The method of claim 1, wherein the method further comprises administering to the patient an agent that stimulates said regulatory T cells. 3. The method of claim 2, wherein the agent is rapamycin, a TGF-.beta., IL-10, IL-4, IFN-.alpha., vitamin D3, dexamethasone, or mycophenolate mofetil. 4. The method of claim 3, wherein the TGF-.beta. is an active or latent form of any one of TGF-.beta.1, TGF-.beta.2, TGF-.beta.3, TGF-.beta.4, and TGF-.beta.5. 5. The method of claim 1, wherein said regulatory T cells are increased at least at one site of inflammation. 6. The method of claim 5, wherein the site of inflammation is blood, central nervous system (CNS), heart, liver, joint, kidney, lung, skin, intestinal tract, or vasculature. 7. The method of claim 1, wherein the anti-CD52 monoclonal antibody reduces the level of urine protein, or urine albumin, or both, in the patient. 8. The method of claim 7, wherein the patient is a human. 9. The method of claim 7, wherein the anti-CD52 monoclonal antibody is a humanized or human anti-CD52 monoclonal antibody. 10. The method of claim 9, wherein the antibody is alemtuzumab. 11. The method of claim 1, wherein the patient is a human. 12. The method of claim 1, wherein the anti-CD52 monoclonal antibody is a humanized or human anti-human CD52 monoclonal antibody. 13. The method of claim 12, wherein the antibody is alemtuzumab. 14. The method of claim 1, wherein the anti-CD52 monoclonal antibody is administered in a monotherapy. 15. The method of claim 14, wherein said regulatory T cells are increased at least at one site of inflammation. 16. The method of claim 14, wherein the patient is a human and wherein the anti-CD52 monoclonal antibody is a humanized or human anti-human CD52 monoclonal antibody. 17. The method of claim 16, wherein the antibody is alemtuzumab.

Details for Patent 9,617,343

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2029-05-13
Genzyme Corporation	LEMTRADA	alemtuzumab	Injection	103948	11/14/2014		2029-05-13
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10/12/2004		2029-05-13