You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 7,393,863


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 7,393,863
Title:Methods of using N-{[2-(2,6-dioxo(3-piperidyl)-1,3-dioxoisoindolin-4-yl]methyl}cyclopropyl- -carboxamide for the treatment and management of myelodysplastic syndromes
Abstract: Methods of treating, preventing and/or managing myelodysplastic syndromes are disclosed. Specific methods encompass the administration of an immunomodulatory compound, or a pharmaceutically acceptable salt, solvate, hydrate, stereoisomer, clathrate, or prodrug thereof, alone or in combination with a second active ingredient, and/or the transplantation of blood or cells. Specific second active ingredients are capable of affecting or blood cell production. Pharmaceutical compositions, single unit dosage forms, and kits suitable for use in methods of the invention are also disclosed.
Inventor(s): Zeldis; Jerome B. (Princeton, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:11/654,550
Patent Claims:1. A method of treating a myelodysplastic syndrome, which comprises administering to a patient in need thereof about 5 to about 100 mg per day of N-{[2-(2,6-dioxo(3-piperidyl)-1,3-dioxoisoindolin-4-yl]methyl}cycl- opropyl-carboxamide having the formula: ##STR00009## or a pharmaceutically acceptable salt, solvate or stereoisomer thereof.

2. The method of claim 1, wherein the compound is N-{[2-(2,6-dioxo(3-piperidyl)-1,3-dioxoisoindolin-4-yl]methyl}cyclopropyl- -carboxamide having the formula: ##STR00010## as a free base.

3. The method of claim 1, wherein the compound is a pharmaceutically acceptable salt.

4. The method of claim 1, wherein the compound is a pharmaceutically acceptable solvate.

5. The method of claim 1, wherein the compound is a pharmaceutically acceptable stereoisomer.

6. The method of claim 5, wherein the stereoisomer is an enantiomerically pure R isomer.

7. The method of claim 5, wherein the stereoisomer is an enantiomerically pure S isomer.

8. The method of claim 1, which further comprises administering a therapeutically effective amount of a second active agent.

9. The method of claim 8, the second active agent is capable of improving blood cell production.

10. The method of claim 8, wherein the second active agent is a cytokine, hematopoietic growth factor, an anti-cancer agent, an antibiotic, a proteasome inhibitor, or an immunosuppressive agent.

11. The method of claim 10, wherein the second active agent is etanercept, imatinib, anti-TNF-.alpha. antibodies, infliximab, G-CSF, GM-CSF, EPO, topotecan, pentoxifylline, ciprofloxacin, irinotecan, vinblastine, dexamethasone, IL2, IL8, IL18, Ara-C, vinorelbine, isotretinoin, 13-cis-retinoic acid, arsenic trioxide or a pharmacologically active mutant or derivative thereof.

12. The method of claim 1, wherein the myelodysplastic syndrome is refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or chronic myelomonocytic leukemia.

13. The method of claim 1, wherein the compound or a pharmaceutically acceptable salt, solvate or stereoisomer thereof is administered before, during or after transplanting umbilical cord blood, placental blood, peripheral blood stem cell, hematopoietic stem cell preparation or bone marrow in the patient.

14. The method of claim 11, wherein the second active agent is dexamethasone.

15. The method of claim 1, wherein the patient is not previously treated for a myelodysplastic syndrome.

16. The method of claim 1, wherein the patient has been previously treated for a myelodysplastic syndrome.

17. The method of claim 1, wherein the compound is administered orally.

18. The method of claim 17, wherein the compound is administered in the form of a capsule or tablet.

19. The method of claim 1, wherein the compound is administered cyclically.

20. The method of claim 19, wherein the compound is administered once or twice every day for sixteen or twenty-four weeks.

21. The method of claim 19, wherein one cycle comprises the administration of the compound and at least one, two, or three weeks of rest.

22. The method of claim 19, wherein the number of cycle is from one to twelve cycles.

23. The method of claim 19, wherein the compound is administered in an amount of from about 5 to about 50 mg per day for 21 days every 28 days for sixteen or twenty-four weeks.

24. The method of claim 4, wherein said solvate is a hydrate.

25. The method of claim 1, wherein the compound is administered in an amount of from about 5 mg per day to about 50 mg per day.

26. The method of claim 1, wherein the compound is administered in an amount of 5 mg per day.

27. The method of claim 1, wherein the compound is administered in an amount of 10 mg per day.

28. The method of claim 1, wherein the compound is administered in an amount of 20 mg per day.

29. The method of claim 1, wherein the compound is administered in an amount of 25 mg per day.

30. The method of claim 1, wherein the compound is administered in an amount of 50 mg per day.

31. The method of claim 1, wherein the compound is administered in an amount of from about 25 mg every other day to about 50 mg every other day.

32. The method of claim 1, wherein the compound is administered in a cycle of about 16 weeks and about once or twice every day.

33. The method of claim 32, wherein said cycle comprises at least one (1), two (2), or three (3) weeks of rest.

34. The method of claim 1, wherein the compound is administered in an amount of 20 mg per day or 50 mg per day for 21 days out of a block of 28 days.

35. The method of claim 1, wherein the compound is administered orally in an amount of 5 mg as a capsule per day.

36. The method of claim 1, wherein the compound is administered orally in an amount of 25 mg as a capsule per day.

Details for Patent 7,393,863

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2022-10-15
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2022-10-15
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2022-10-15
Immunex Corporation ENBREL etanercept Injection 103795 09/27/2004 ⤷  Try a Trial 2022-10-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.