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Onyx Pharmaceuticals Presents Interim Results of Phase 1b Carfilzomib Combination Trial
Date:6/4/2010

equent months while remaining on the initial doses of each agent.

"Based on promising results from this trial, we are planning to enroll patients in a Phase 3 trial to further evaluate this three-drug combination therapy in patients with relapsed myeloma," said Michael Kauffman, M.D., Ph.D., Chief Medical Officer at Onyx.  "Later this year, we expect to submit a U.S. New Drug Application filing for carfilzomib as a single agent for relapsed/refractory myeloma under the accelerated approval mechanism, pending the top-line results from our Phase 2b trial, known as the 003-A1 study."  

About the Carfilzomib Development Program

Carfilzomib is a selective, next-generation proteasome inhibitor that is being investigated in a broad clinical trial program in multiple myeloma.

The pivotal Phase 2b monotherapy study, also known as 003-A1, enrolled patients with relapsed/refractory multiple myeloma.  Top-line results, expected mid-year, may support the filing of a U.S. New Drug Application (NDA) by year-end 2010.  

A European Phase 3 clinical trial of carfilzomib is planned in relapsed/refractory myeloma and is designed to support a registrational filing with the EMA. Carfilzomib is also being evaluated in advanced solid tumors.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the U.S., more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.(ii)  According to estimates by the

SOURCE Onyx Pharmaceuticals, Inc.
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