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Last Updated: March 28, 2024

Claims for Patent: 9,295,669


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Summary for Patent: 9,295,669
Title:Combination therapy for proliferative disorders
Abstract: The present invention relates to a combination therapy of propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]-amide}, or a pharmaceutically acceptable salt thereof, and an interferon for treating a patient suffering from a proliferative disorder, in particular a solid tumor, for example, colorectal cancer, melanoma, and thyroid cancer. In particular, the present invention relates to such a therapy wherein the interferon is peginterferon alfa-2a and the disorder is melanoma containing the V600E b-Raf mutation.
Inventor(s): Dhingra; Kapil (Sparta, NJ), Higgins; Brian (Fresh Meadows, NY), Kolinsky; Kenneth (Bloomingdale, NJ), Lee; Richard J. (New York, NY), Lestini; Brian (Union City, NJ), Packman; Kathryn (Bloomfield, NJ), Su; Fei (Paramus, NJ)
Assignee: Hoffman La-Roche Inc. (Nutley, NJ)
Application Number:13/313,042
Patent Claims:1. A method of treating a patient suffering from a proliferative disorder, comprising administering to the patient: (A) a first component which comprises, as an active agent, propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof; and (B) a second component which comprises, as an active agent, peginterferon alfa-2a; wherein said propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide} is administered in an amount of from about 1700 mg/day to about 2100 mg/day, wherein said amount is about 25 mg/kg, and said peginterferon alfa-2a is administered in an amount of from about 180 .mu.g/week to about 630 .mu.g/week, and wherein said proliferative disorder is selected from the group consisting of: colorectal cancer, melanoma, and thyroid cancer, wherein said cancer involves a tumor comprising b-Raf having the V600E mutation.

2. A method according to claim 1 wherein said patient is a human.

3. A method according to claim 1 wherein said proliferative disorder is melanoma containing the V600E b-Raf mutation.

4. A method according to claim 1 wherein propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, is substantially in amorphous form.

5. A method according to claim 1 wherein propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, is in amorphous form.

6. A method according to claim 1 wherein propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, is contained in a solid molecular complex formed with hydroxypropyl methyl cellulose acetate succinate such that it is immobilized in its amorphous form.

7. A method according to claim 6 wherein the amounts of propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, are hydroxypropyl methyl cellulose acetate succinate in said complex are in a ratio of from about 1:9 to about 5:5, respectively.

8. A method according to claim 6 wherein the amounts of propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, and hydroxypropyl methyl cellulose acetate succinate in said complex are in a ratio of about 3:7, respectively.

9. A method according to claim 6 wherein said first component comprises a blend wherein about 97% by weight of the blend is said complex and about 3% by weight of the blend is silicon dioxide.

10. A method according to claim 6 wherein said first component comprises a suspension of said complex in a pharmaceutically acceptable carrier.

11. A method according to claim 1 wherein said first component comprises a tablet comprising a solid molecular complex of propane-1-sulfonic acid{3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl-2,4-difl- uoro-phenyl]amide}, or a pharmaceutically acceptable salt thereof, and hydroxypropyl methyl cellulose acetate succinate.

Details for Patent 9,295,669

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Zr Pharma& Gmbh PEGASYS peginterferon alfa-2a Injection 103964 10/16/2002 ⤷  Try a Trial 2030-12-14
Zr Pharma& Gmbh PEGASYS peginterferon alfa-2a Injection 103964 01/07/2004 ⤷  Try a Trial 2030-12-14
Zr Pharma& Gmbh PEGASYS peginterferon alfa-2a Injection 103964 09/29/2011 ⤷  Try a Trial 2030-12-14
Hoffmann-la Roche Inc. PEGASYS COPEGUS COMBINATION PACK peginterferon alfa-2a and ribavirin 125083 06/04/2004 ⤷  Try a Trial 2030-12-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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