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Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
Date:9/6/2007

iate the TIME-1 trial at the end of 2007 or early 2008.

"Kosan's successful completion of both the Special Protocol Assessment process with the FDA and Scientific Advice from the EMEA for our TIME-1 trial provides us with a clear roadmap to registration in major countries around the world for this potentially important new treatment for patients with multiple myeloma," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "We believe that Kosan's TIME program is the most advanced Hsp90 inhibitor clinical program in the industry, underscoring Kosan's leadership in this promising new class of anticancer therapies. We appreciate the widespread support we have received from the US and international myeloma clinician and patient communities."

About TIME

The TIME clinical program utilizes Kosan's improved, proprietary injectable suspension formulation of tanespimycin. The injectable suspension formulation is designed to provide important benefits, including improved patient safety, due to the elimination of Cremophor(R) and the associated need for steroid premedication to prevent hypersensitivity reactions. Tanespimycin injectable suspension also has a potentially enhanced intellectual property position and permits easier drug preparation and administration compared to the prior formulation.

The TIME-1 trial will be an open-label, randomized, multi-center trial conducted in the US and in Europe that is designed to enroll over 450 patients with relapse of multiple myeloma following a single prior course of treatment (first-relapse). The trial is designed to compare two groups: patients treated with bortezomib plus tanespimycin and patients treated with bortezomib alone. Tanespimycin will be administered at a dose of 340 mg/m2 and all patients will receive standard doses of bortezomib (1.3 mg/m2). TIME-1 is designed with a primary endpoint of progression-free survival. TIME-1 is designed to include an interim analys
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SOURCE Kosan Biosciences Incorporated
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