IP Library Granted Patent US 11,786,523
Granted Patent B2
US 11,786,523 · App. 16/964,401 · Granted Oct 17, 2023

Composition and method for reducing thrombocytopenia

Inventors: Lan Huang (New York, NY); Ramon Mohanlal (New York, NY); George Kenneth Lloyd (New York, NY)
Assignee: BEYONDSPRING PHARMACEUTICALS, INC.
A61K31/496A61K31/7068A61P7/02
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Quick Facts
Patent No.
US 11,786,523
App. No.
16/964,401
Granted
Oct 17, 2023
Kind
B2
Abstract

Disclosed herein are methods of reducing or preventing thrombocytopenia, in a clinically relevant manner, that is caused by chemotherapy or radiation therapy by administering plinabulin to a subject.

Claims (34)

1. A method of reducing thrombocytopenia, comprising administering plinabulin or a pharmaceutically acceptable salt thereof to a subject in need thereof, wherein the thrombocytopenia is induced by administration of gemcitabine or a chemotherapeutic composition comprising gemcitabine.

2. The method of claim 1 , wherein the subject has a grade 1 thrombocytopenia.

3. The method of claim 1 , wherein the subject has a grade 2 thrombocytopenia.

4. The method of claim 1 , wherein the subject has a grade 3 thrombocytopenia.

5. The method of claim 1 , wherein the subject has a grade 4 thrombocytopenia.

6. The method of claim 1 , wherein the plinabulin is administered at a dose in the range of about 2.5 mg/m 2 to about 17.5 mg/m 2 .

7. The method of claim 1 , wherein the plinabulin is administered at a dose in the range of about 8.5 mg/m 2 to about 32.5 mg/m 2 .

8. The method of claim 1 , wherein the plinabulin is administered at a dose in the range of about 9.5 mg/m 2 to about 15.5 mg/m 2 .

9. The method of claim 1 , wherein the plinabulin is administered at a dose in the range of about 15.5 mg/m 2 to about 24.5 mg/m 2 .

10. The method of claim 1 , further comprising administering gemcitabine prior to administering plinabulin.

11. The method of claim 10 , wherein the gemcitabine is administered about 1 hour prior to plinabulin administration.

12. The method of claim 1 , comprising reducing an incidence of a thrombocytopenia by at least 10%.

13. The method of claim 1 , comprising reducing an incidence of a thrombocytopenia by at least 30%.

14. The method of claim 1 , comprising reducing a duration of a thrombocytopenia by at least 50%.

15. A method of increasing platelet production, stimulating platelet formation, or increasing platelet count in a subject being administered gemcitabine, comprising administering plinabulin or a pharmaceutically acceptable salt thereof to the subject in need thereof.

16. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 1 mg/m 2 to about 50 mg/m 2 .

17. The method of claim 15 , wherein the subject has a grade 1 thrombocytopenia.

18. The method of claim 15 , wherein the subject has a grade 2 thrombocytopenia.

19. The method of claim 15 , wherein the subject has a grade 3 thrombocytopenia.

20. The method of claim 15 , wherein the subject has a grade 4 thrombocytopenia.

21. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 2.5 mg/m 2 to about 17.5 mg/m 2 .

22. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 8.5 mg/m 2 to about 32.5 mg/m 2 .

23. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 9.5 mg/m 2 to about 15.5 mg/m 2 .

24. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 15.5 mg/m 2 to about 24.5 mg/m 2 .

25. The method of claim 15 , wherein the plinabulin is administered at a dose in the range of about 22.5 mg/m 2 to about 32.5 mg/m 2 .

26. The method of claim 15 , further comprising administering gemcitabine prior to administering plinabulin.

27. The method of claim 26 , wherein the gemcitabine is administered about 1 hour prior to plinabulin administration.

28. The method of claim 15 , comprising reducing an incidence of a thrombocytopenia by at least 10%.

29. The method of claim 15 , comprising reducing an incidence of a thrombocytopenia by at least 30%.

30. The method of claim 15 , comprising reducing a duration of a thrombocytopenia by at least 50%.

31. A method of treating thrombocytopenia, comprising:

identifying a subject having a breast cancer, ovarian cancer, non-small cell lung cancer, pancreatic cancer, or bladder cancer; and

administering plinabulin or a pharmaceutically acceptable salt thereof to the subject in need thereof at a dose in the range of about 1 mg/m 2 to about 50 mg/m 2 to the subject;

wherein the thrombocytopenia is induced by administration of gemcitabine or a chemotherapeutic composition comprising gemcitabine.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 10, 2020
From: HUANG, LAN; MOHANLAL, RAMON; LLOYD, GEORGE KENNETH
To: BEYONDSPRING PHARMACEUTICALS, INC.
Reel/Frame 054322/0842 →
Continuity (3)
Provisional Application 62718814 · Aug 14, 2018
Provisional Application 62621543 · Jan 24, 2018
Related Publication 20210046068A1 · Feb 18, 2021
Cited By (3)
US 12,377,094 US 12,433,886 US 12,458,639