IP Library Granted Patent US 10,028,940
Granted Patent B2
US 10,028,940 · App. 15/461,131 · Granted Jul 24, 2018

Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders

Inventors: Michael E. Bozik (Pittsburgh, PA); Steven Dworetzky (Jefferson Hills, PA)
Assignee: Knopp Biosciences LLC
A61K31/428
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Quick Facts
Patent No.
US 10,028,940
App. No.
15/461,131
Granted
Jul 24, 2018
Kind
B2
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.

Claims (28)

1. A method of treating multiple myeloma in a subject comprising administering to the subject in need thereof a therapeutically effective amount of dexpramipexole or a pharmaceutically acceptable salt thereof.

2. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole is from about 1 mg to about 1,000 mg per day.

3. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole is from about 50 mg to about 600 mg per day.

4. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole is from about 150 mg to about 300 mg per day.

5. The method of claim 1 , wherein administering is selected from a group consisting of administering a fraction of the therapeutically effective amount two or more times per day, administering an amount equal to about half of the therapeutically effective amount twice per day, and administering the therapeutically effective amount every 12 hours.

6. The method of claim 1 , wherein administering comprises administering about 150 mg two times per day.

7. The method of claim 1 , further comprising an induction step, wherein said induction step is selected from a group consisting of 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-α inhibitor, a fusion protein, an anti-inflammatory drug, and a combination thereof.

8. The method of claim 7 , wherein the tyrosine kinase inhibitor is imatinib.

9. The method of claim 7 , wherein the anti IL-5 monoclonal antibody is selected from the group consisting of mepolizumab and reslizumab.

10. The method of claim 7 , wherein the IL-5 receptor monoclonal antibody is benralizumab.

11. The method of claim 7 , wherein the anti IL-13 monoclonal antibody is lebrikizumab.

12. The method of claim 7 , wherein the anti IL-4 receptor monoclonal antibody is dupilumab.

13. The method of claim 7 , wherein the anti IgE monoclonal antibody is omalizumab.

14. The method of claim 7 , wherein the TNF-α inhibitor is selected from the group consisting of infliximab, adalimumab, certolizumab pegol, and golimumab.

15. The method of claim 7 , wherein the fusion protein is etanercept.

16. The method of claim 1 , wherein administering comprises administering about 75 mg two times per day.

17. The method of claim 1 , wherein administering comprises administering about 300 mg two times per day.

18. The method of claim 1 , wherein the therapeutically effective amount of dexpramipexole is administered as an initial dosing regimen and then as a maintenance dosing regimen.

19. The method of claim 18 , wherein the therapeutically effective amount of the initial dosing regimen is from about 50 mg to about 1,500 mg per day.

20. The method of claim 18 , wherein the therapeutically effective amount of the initial dosing regimen is from about 150 mg to about 300 mg per day.

21. The method of claim 18 , wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 500 mg per day.

22. The method of claim 18 , wherein the therapeutically effective amount of the initial dosing regimen is from about 300 mg to about 600 mg per day.

23. The method of claim 18 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 50 mg to about 1,500 mg per day.

24. The method of claim 18 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 150 mg to about 300 mg per day.

25. The method of claim 18 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 500 mg per day.

26. The method of claim 18 , wherein the therapeutically effective amount of the maintenance dosing regimen is from about 300 mg to about 600 mg per day.

27. The method of claim 1 , wherein the therapeutically effective amount is administered orally.

28. The method of claim 1 , wherein the therapeutically effective amount is administered topically.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Nov 21, 2025
From: HERCULES CAPITAL, INC., AS AGENT
To: ARETEIA THERAPEUTICS, INC.
Reel/Frame 072993/0621 →
SECURITY INTEREST Recorded Oct 10, 2025
From: ARETEIA THERAPEUTICS, INC.
To: HERCULES CAPITAL, INC., AS AGENT
Reel/Frame 072540/0980 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2023
From: KNOPP BIOSCIENCES LLC
To: ARETEIA THERAPEUTICS, INC.
Reel/Frame 062849/0759 →
RELEASE OF SECURITY INTEREST Recorded Apr 12, 2022
From: AMERICAN MONEY MANAGEMENT CORPORATION
To: KNOPP BIOSCIENCES LLC
Reel/Frame 059572/0530 →
SECURITY INTEREST Recorded Apr 12, 2021
From: KNOPP BIOSCIENCES LLC
To: AMERICAN MONEY MANAGEMENT CORPORATION
Reel/Frame 055889/0064 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2017
From: DWORETZKY, STEVEN
To: KNOPP BIOSCIENCES LLC
Reel/Frame 043891/0802 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2017
From: BOZIK, MICHAEL E.
To: KNOPP BIOSCIENCES LLC
Reel/Frame 043891/0615 →
Continuity (4)
Continuation 14912058
Provisional Application 61987117 · May 1, 2014
Provisional Application 61865592 · Aug 13, 2013
Related Publication 20170281604A1 · Oct 5, 2017