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Last Updated: March 29, 2024

Claims for Patent: 8,906,932


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Summary for Patent: 8,906,932
Title:Methods of treating cancer using 3-(5-amino-2-methyl-4-oxo-4Hquinazolin-3-yl)-piperidine-2,6-dione
Abstract: Provided herein are methods of treating, preventing and/or managing cancers, which comprise administering to a patient 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or an enantiomer or a mixture of enantiomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, or polymorph thereof.
Inventor(s): Muller; George W. (Rancho Santa Fe, CA), Schafer; Peter H. (Somerset, NJ), Man; Hon-Wah (Princeton, NJ), Zhang; Ling-Hua (Mountain Lakes, NJ), Gandhi; Anita (Bernardsville, NJ), Chopra; Rajesh (Summit, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:13/417,088
Patent Claims:1. A method of treating or managing non-Hodgkin's lymphoma, comprising administering to a patient in need of such treatment or management a therapeutically effective amount of 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, which has the following structure: ##STR00004## or an enantiomer or mixture of enantiomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, or polymorph thereof; wherein the non-Hodgkin's lymphoma is diffuse large B-cell lymphoma of the activated B-cell phenotype.

2. The method of claim 1, wherein the diffuse large B-cell lymphoma is characterized by the expression of one or more biomarkers overexpressed in RIVA, U2932, TMD8 or OCI-Ly10 cell lines.

3. The method of claim 1, wherein the non-Hodgkin's lymphoma is relapsed or refractory.

4. The method of claim 1, wherein the non-Hodgkin's lymphoma is drug-resistant.

5. A method for treating or managing non-Hodgkin's lymphoma, comprising: (i) identifying a patient having non-Hodgkin's lymphoma sensitive to treatment with 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione; and (ii) administering to the patient a therapeutically effective amount of 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione or a pharmaceutically acceptable salt, solvate or hydrate thereof; wherein the non-Hodgkin's lymphoma is diffuse large B-cell lymphoma of the activated B-cell phenotype.

6. The method of claim 5, wherein the diffuse large B-cell lymphoma is characterized by the expression of one or more biomarkers overexpressed in RIVA, U2932, TMD8 or OCI-Ly10 cell lines.

7. The method of claim 5, wherein identifying a patient having non-Hodgkin's lymphoma sensitive to treatment with 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or a salt, solvate or hydrate thereof, comprises characterization of the non-Hodgkin's lymphoma phenotype of the patient as an activated B-cell subtype.

8. The method of claim 7, wherein the non-Hodgkin's lymphoma phenotype is characterized as an activated B-cell subtype of diffuse large B-cell lymphoma.

9. The method of claim 7, wherein the non-Hodgkin's lymphoma phenotype is characterized by the expression of one or more biomarkers overexpressed in RIVA, U2932, TMD8 or OCI-Ly10 cell lines.

10. The method of claim 5, wherein identification of the non-Hodgkin's lymphoma phenotype comprises obtaining a biological sample from a patient having lymphoma.

11. The method of claim 10, wherein the biological sample is a lymph node biopsy, a bone marrow biopsy, or a sample of peripheral blood tumor cells.

12. The method of claim 5, wherein identifying a patient having non-Hodgkin's lymphoma sensitive to treatment with 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or a salt, solvate or hydrate thereof, comprises identification of a gene associated with the activated B-cell phenotype.

13. The method of claim 12, wherein the gene associated with the activated B-cell phenotype is selected from the group consisting of IRF4/MUM1, FOXP1, SPIB, CARD11 and BLIMP/PDRM1.

14. The method of claim 5, wherein identifying a patient having non-Hodgkin's lymphoma sensitive to treatment with 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or a salt, solvate or hydrate thereof, comprises measuring the level of NF-.kappa.B activity in a biological sample obtained from the patient.

15. The method of claim 14, wherein the biological sample is a lymph node biopsy, a bone marrow biopsy, or a sample of peripheral blood tumor cells.

16. The method of claim 7, wherein characterization of the non-Hodgkin's lymphoma phenotype of the patient as an activated B-cell subtype comprises measuring one or more of the following: (i) overexpression of SPIB, a hematopoietic-specific Ets family transcription factor required for survival of activated B-cell subtype cells; (ii) higher constitutive IRF4/MUM1 expression than GCB subtype cells; (iii) higher constitutive FOXP1 expression up-regulated by trisomy 3; (iv) higher constitutive Blimp1, i.e., PRDM1, expression; (v) higher constitutive CARD11 gene expression; and (vi) an increased level of NF-.kappa.B activity relative to non-activated B-cell subtype DLBCL cells.

17. The method of claim 1, wherein the compound is 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione hydrochloride, or a salt, solvate or hydrate thereof.

18. The method of claim 1, further comprising the administration of a therapeutically effective amount of one or more additional active agents.

19. The method of claim 18, wherein the additional active agent is selected from the group consisting of an alkylating agent, an adenosine analog, a glucocorticoid, a kinase inhibitor, a SYK inhibitor, a PDE3 inhibitor, a PDE7 inhibitor, doxorubicin, chlorambucil, vincristine, bendamustine, forskolin and rituximab.

20. The method of claim 19, wherein the additional active agent is rituximab.

21. The method of claim 1, wherein 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or a pharmaceutically acceptable salt, solvate or hydrate thereof is administered in an amount of from about 0.5 to about 50 mg per day.

22. The method of claim 21, wherein the compound is administered in an amount of about 0.5 to about 5 mg per day.

23. The method of claim 21, wherein the compound is administered in an amount of about 0.5, 1, 2, 4, 5, 10, 15, 20, 25 or 50 mg per day.

24. The method of claim 21, wherein the compound is orally administered.

25. The method of claim 21, wherein the compound is administered in a capsule or tablet.

26. The method of claim 25, wherein the compound is administered in 10 mg or 25 mg of a capsule.

27. The method of claim 1, wherein the compound is administered for 21 days followed by seven days rest in a 28 day cycle.

Details for Patent 8,906,932

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2031-03-11
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 02/19/2002 ⤷  Try a Trial 2031-03-11
Genentech, Inc. RITUXAN HYCELA rituximab and hyaluronidase human Injection 761064 06/22/2017 ⤷  Try a Trial 2031-03-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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