Claims for Patent: 10,456,381

Summary for Patent: 10,456,381

Title:	Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders
Abstract:	Disclosed herein are methods of treating conditions, which may be associated with elevated levels of plasma cells and/or B-cells, with a therapeutically effective amount of dexpramipexole or pharmaceutical acceptable salt thereof.
Inventor(s):	Bozik; Michael E. (Pittsburgh, PA), Dworetzky; Steven (Jefferson Hills, PA)
Assignee:	Knopp Biosciences LLC (Pittsburgh, PA)
Application Number:	16/013,071
Patent Claims:	1. A method of treating a condition characterized by elevated levels of B-cells in a subject, comprising: administering to the subject in need thereof, a therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, wherein the condition is selected from the group consisting of diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma (MZL), small cell lymphocytic lymphoma, mantle cell lymphoma (MCL), Burkitt lymphoma, Waldenstrom's macroblobulinemia, B-cell leukemia, and any combination thereof. 2. The method of claim 1, wherein the B-cell leukemia is selected from the group consisting of B-cell chronic lymphocytic leukemia, B-cell acute lymphoblastic leukemia, B-cell acute lymphocytic leukemia, B-cell prolymphocytic leukemia, precursor B-cell lymphoblastic leukemia, hairy cell leukemia, and any combination thereof. 3. The method of claim 1, wherein the condition is further characterized by elevated levels of B-cell prolymphocytes in the peripheral blood. 4. The method of claim 1, wherein treating the condition results in a reduction of the levels of B-cells. 5. The method of claim 4, wherein the reduction of the levels of B-cells is in peripheral blood, a tissue, or a combination thereof. 6. The method of claim 5, wherein the tissue is selected from the group consisting of bone marrow, bone, kidney, lymph nodes, and any combinations thereof. 7. The method of claim 4, wherein the levels of B-cells are reduced by about 10% to about 100%. 8. The method of claim 4, wherein the levels of B-cells are reduced to normal. 9. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 1 mg to about 1,000 mg per day. 10. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 50 mg to about 600 mg per day. 11. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is from about 150 mg to about 300 mg per day. 12. The method of claim 1, wherein administering is selected from the group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering a dose equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours. 13. The method of claim 1, wherein administering comprises administering about 150 mg two times per day. 14. The method of claim 1, wherein administering comprises administering about 75 mg two times per day. 15. The method of claim 1, wherein administering comprises administering about 300 mg two times per day. 16. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole, or a pharmaceutically acceptable salt thereof, is administered via a route of administration selected from the group consisting of orally, by inhalation, intranasally, via intravenous administration, topically, and any combination thereof. 17. The method of claim 1, wherein the therapeutically effective amount is administered orally. 18. The method of claim 1, further comprising an induction step, wherein said induction step is administering a therapeutic agent selected from the group consisting of a glucocorticoid, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAID), a tyrosine kinase inhibitor, a fusion protein, a monoclonal antibody directed against one or more pro-inflammatory cytokines, a chemotherapeutic agent, a phenolic antioxidant, an anti-proliferative drug, an anti IL-5 monoclonal antibody, an IL-5 receptor monoclonal antibody, an anti IL-13 monoclonal antibody, an anti IL-13 receptor monoclonal antibody, an anti IL-4 monoclonal antibody, an anti IL-4 receptor monoclonal antibody, an anti IgE monoclonal antibody, a TNF-.alpha. inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof. 19. The method of claim 18, wherein the tyrosine kinase inhibitor is imatinib. 20. The method of claim 18, wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab, reslizumab, and combinations thereof. 21. The method of claim 18, wherein the IL-5 receptor monoclonal antibody is benralizumab. 22. The method of claim 18, wherein the anti IL-13 monoclonal antibody is lebrikizumab. 23. The method of claim 18, wherein the anti IL-4 receptor monoclonal antibody is dupilumab. 24. The method of claim 18, wherein the anti IgE monoclonal antibody is omalizumab. 25. The method of claim 18, wherein the TNF-.alpha. inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, golimumab, and combinations thereof. 26. The method of claim 18, wherein the fusion protein is etanercept. 27. The method of claim 1, wherein the therapeutically effective amount of dexpramipexole, or pharmaceutically acceptable salt thereof, is administered as an initial dosing regimen and then as a maintenance dosing regimen. 28. The method of claim 27, wherein the therapeutically effective amount of the initial dosing regimen is from about 50 mg to about 1,500 mg per day. 29. The method of claim 27, wherein the therapeutically effective amount of the initial dosing regimen is from about 150 mg to about 300 mg per day. 30. The method of claim 27, wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 500 mg per day. 31. The method of claim 27, wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 600 mg per day. 32. The method of claim 27, wherein the therapeutically effective amount of the maintenance dosing regimen is from about 50 mg to about 1,500 mg per day. 33. The method of claim 27, wherein the therapeutically effective amount of the maintenance dosing regimen is from about 150 mg to about 300 mg per day. 34. The method of claim 27, wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 500 mg per day. 35. The method of claim 27, wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 600 mg per day. 36. The method of claim 18, wherein said induction step is from about 1 week to about 6 months.

Details for Patent 10,456,381

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2033-08-13
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2033-08-13
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2033-08-13
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2033-08-13
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2033-08-13