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Kosan Opens TIME-1 Pivotal Phase 3 Trial in Multiple Myeloma
Date:1/3/2008

Kosan Leads Industry with Most Advanced Hsp90 Inhibitor in Clinical

Development New Supportive Trial in Less Refractory Patients to Replace Current TIME-2

Trial

Conference Call and Webcast Today

HAYWARD, Calif., Jan. 3 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that the Tanespimycin in Myeloma Evaluation or TIME-1 pivotal Phase 3 trial for tanespimycin as a potential treatment for multiple myeloma is open for enrollment. TIME-1 is a pivotal Phase 3 trial comparing tanespimycin in combination with bortezomib (Velcade(R)) with bortezomib alone in patients following a single prior course of treatment (first-relapse). Kosan has completed both a Special Protocol Assessment with the U.S. Food and Drug Administration and a Scientific Advice process with the Committee for Medicinal Products for Human Use of the centralized European Medicines Agency, thus, providing what the company believes is a validated path to registration in many major world markets for the TIME-1 trial. TIME-1 is the most advanced Hsp90 inhibitor clinical program in the industry, underscoring the company's leadership in this new class of anticancer therapies.

The TIME registration program is designed to include two trials: a pivotal Phase 3 trial (TIME-1) and a smaller supportive trial. The TIME-1 trial is proceeding on track and remains the foundation of the company's registration strategy. The TIME-2 trial, recently opened for patients who have failed numerous (at least three) prior myeloma therapies, will be closed and replaced with an alternative supportive trial. TIME-2 had been designed to support TIME-1 for full appr
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SOURCE Kosan Biosciences Incorporated
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