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 29, 2024

Claims for Patent: 8,623,384


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,623,384
Title:Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of acute myelogenous leukemia
Abstract: Methods of treating, preventing or managing leukemias are disclosed. The methods encompass the administration of an immunomodulatory compound of the invention known as Revlimid.RTM. or lenalidomide. The invention further relates to methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods of the invention are also disclosed.
Inventor(s): Zeldis; Jerome B. (Princeton, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:13/889,473
Patent Claims:1. A method of treating acute myelogenous leukemia in a human, which comprises administering for a period of time, followed by a rest for a period of time, and repeating this sequential administration, to a human having acute myelogenous leukemia escalating doses of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, wherein a starting dose is between about 2.5 mg/day and about 25 mg/day, and a maximum dose is between about 25 mg/day and about 75 mg/day.

2. The method of claim 1, wherein the acute myelogenous leukemia is relapsed, refractory or resistant to conventional therapy.

3. A method of treating acute myelogenous leukemia in a human, which comprises administering for a period of time, followed by a rest for a period of time, and repeating this sequential administration, to a human having acute myelogenous leukemia escalating doses of 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, wherein a starting dose is between about 2.5 mg/day and about 10 mg/day, and a maximum dose is between about 5 mg/day and about 50 mg/day; and a therapeutically effective amount of a second active agent.

4. The method of claim 3, wherein the second active agent is an antibody, hematopoietic growth factor, cytokine, anti-cancer agent, antibiotic, cox-2 inhibitor, immunomodulatory agent, immunosuppressive agent, or corticosteroid.

5. The method of claim 3, wherein the second active agent is rituximab, fludarabine, azacitidine or a combination thereof.

6. The method of claim 5, wherein 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione is administered after the administrations of rituximab and fludarabine.

7. The method of claim 1 or 3, wherein the starting dose of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 25 mg per day.

8. The method of claim 1 or 3, wherein the amount of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 35 mg per day.

9. The method of claim 8, wherein the maximum dose of 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione administered is about 50 mg per day.

10. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered daily on days 1 through 21 followed by seven days rest in each 28 day cycle.

11. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione administered is enantiomerically pure.

12. The method of claim 11, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione administered is S enantiomer.

13. The method of claim 11, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione administered is R enantiomer.

14. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered in the form of a capsule or tablet.

15. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered in an amount of about 25 mg/day to 50 mg/day for 21 days followed by seven days rest in each 28 day cycle.

16. The method of claim 15, further comprising administration of rituximab in an amount of 375 mg/m.sup.2.

17. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered orally.

18. The method of claim 1 or 3, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered in the form of a capsule.

19. The method of claim 18, wherein 3-(4-amino-oxo-1,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione is administered in the capsule of 5 mg, 10 mg, 15 mg, or 25 mg.

20. The method of claim 18, wherein the capsule comprises the 3-(4-amino-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, lactose anhydrous, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.

21. The method of claim 1 or 3, wherein the starting dose is escalated each week.

22. The method of claim 1 or 3 wherein the starting dose is escalated every 28 days.

23. The method of claim 3 wherein the second active agent is dexamethasone, prednisone, or a combination thereof.

Details for Patent 8,623,384

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2022-05-17
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2022-05-17
Genentech, Inc. RITUXAN HYCELA rituximab and hyaluronidase human Injection 761064 06/22/2017 ⤷  Try a Trial 2022-05-17
>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.