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Proteolix Initiates Phase 1b Clinical Trial of Carfilzomib in a Combination Regimen for Patients With Relapsed Multiple Myeloma
Date:7/10/2008

Provides Update on Carfilzomib Development Program in Multiple Myeloma

SOUTH SAN FRANCISCO, Calif., July 10 /PRNewswire/ -- Proteolix, Inc. today announced that patient dosing has commenced in a Phase 1b clinical trial to evaluate the safety and efficacy of Proteolix's lead anti-cancer agent, carfilzomib (PR-171), in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma. Carfilzomib selectively blocks proteasome activity, causing apoptosis in cancer cells. In single agent Phase 1 studies carfilzomib has demonstrated encouraging anti-tumor activity and has been generally well tolerated.

The Phase 1b clinical trial is designed to evaluate safety and to establish a maximum-tolerated dose of carfilzomib in combination with lenalidomide and dexamethasone on a twenty-eight day treatment cycle. Lenalidomide in combination with dexamethasone is indicated for use in patients with multiple myeloma who have had at least one prior therapy. Patients will be divided into four cohorts and will receive escalating doses of carfilzomib and lenalidomide, combined with a set dose of dexamethasone. A secondary endpoint for the trial is overall response rate at four months.

"Carfilzomib has been generally well-tolerated in patients and we believe that the product's selectivity and potency provide a solid rationale for use in combination with existing treatment protocols," said Lori Kunkel, M.D., Proteolix's Chief Medical Officer. "Initiating our first combination trial of carfilzomib complements our multi-pronged strategy to thoroughly explore carfilzomib's potential in the treatment of patients with multiple myeloma for whom treatment options may be limited."

Carfilzomib Clinical Program in Multiple Myeloma

In addition to the Phase 1b clinical trial announced today, Proteolix is currently evaluating carfilzomib as a single agent for the treatment of multiple myeloma in two Phase 2 clinical trials.

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SOURCE Proteolix, Inc.
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