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Last Updated: October 17, 2019

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Claims for Patent: 7,611,702

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Summary for Patent: 7,611,702
Title:TNF-alpha blocker treatment for enterocolitis associated with immunostimulatory therapeutic antibody therapy
Abstract: The present invention provides methods for treating adverse events related to immunotherapy. More specifically, the present invention provides methods for treating the enterocolitis associated with anti-CTLA-4 antibody immunotherapy.
Inventor(s): Fischkoff; Steven (Short Hills, NJ), Lowy; Israel (Dobbs Ferry, NY), Yellin; Michael (Montclair, NJ), Yang; James Chung-Yin (Silver Spring, MD)
Assignee: Medarex, Inc. (Princeton, NJ)
Application Number:11/557,835
Patent Claims:1. A method for treating enterocolitis induced by an-anti-CTLA-4 antibody in a patient, comprising administering to the patient an amount of a TNF-.alpha. blocking agent effective to treat the enterocolitis, wherein the TNF-.alpha. blocking agent is selected from the group consisting of an anti-TNF-.alpha. antibody and a TNF receptor fusion protein.

2. The method of claim 1, wherein the anti-CTLA-4 antibody is a human sequence antibody that binds to human CTLA-4.

3. The method of claim 2, wherein the anti-CTLA-4 antibody is 10D1 (ipilimumab).

4. The method of claim 1, wherein the anti-TNF-.alpha. antibody is selected from the group consisting of infliximab, certolizumab pegol (CDP870), golimumab and adalimumab.

5. The method of claim 4, wherein the anti-TNF-.alpha. antibody is infliximab.

6. The method of claim 5, comprising administering infliximab in a single dose of about 5 mg/kg.

7. The method of claim 1, wherein the TNF-.alpha. blocking agent is administered intravenously.

8. The method of claim 1, wherein the anti-CTLA-4 antibody is for the treatment of cancer.

9. The method of claim 8, wherein the cancer is metastatic melanoma or renal cell carcinoma.

10. A method for treating enterocolitis induced by an-anti-CTLA-4 antibody in a patient, comprising administering to the patient an amount of a TNF-.alpha. blocking agent effective to treat the enterocolitis, wherein the TNF-.alpha. blocking agent is selected from the group consisting of an anti-TNF-.alpha. antibody and a TNF receptor fusion protein, wherein the enterocolitis induced by an anti-CTLA-4 antibody is refractory to steroid treatment.

11. The method of claim 10, wherein the anti-CTLA-4 antibody is a human sequence antibody that binds to human CTLA-4.

12. The method of claim 11, wherein the anti-CTLA-4 antibody is 10D1 (ipilimumab).

13. The method of claim 10, wherein the anti-TNF-.alpha. antibody is selected from the group consisting of infliximab, certolizumab pegol (CDP870), golimunab, and adalimumab.

14. The method of claim 13, wherein the anti-TNF-.alpha. antibody is infliximab.

15. The method of claim 14, comprising administering infliximab in a single dose of about 5 mg/kg.

16. The method of claim 10, wherein the TNF-.alpha. blocking agent is administered intravenously.

17. The method of claim 10, wherein the anti-CTLA-4 antibody is for the treatment of cancer.

18. The method of claim 17, wherein the cancer is metastatic melanoma or renal cell carcinoma.

19. The method of claim 1 or 10, further comprising administering an effective amount of a gut-decontaminating antibiotic to the patient.

20. The method of claim 1 or 10, wherein the TNF receptor fusion protein is etanercept.

Details for Patent 7,611,702

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Centocor Inc REMICADE infliximab VIAL 103772 001 1998-08-24   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX Orphan search
Immunex ENBREL etanercept VIAL; SUBCUTANEOUS 103795 001 1998-11-02   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX Orphan search
Immunex ENBREL etanercept SYRINGE 103795 002 1998-11-02   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX Orphan search
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX search
Ucb Inc CIMZIA certolizumab pegol INJECTABLE; INJECTION 125160 001 2008-04-22   Start Trial Medarex, Inc. (Princeton, NJ) 2025-11-08 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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