Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multip...( Tanespimycin is the First Hsp90 In...),Health

Tanespimycin is the First Hsp90 Inhibitor to Enter Registration Trials

HAYWARD, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that it has successfully reached a binding agreement with the U.S. Food and Drug Administration (FDA) on the design of its TIME-1 clinical trial, a pivotal Phase 3 trial of its Hsp90 inhibitor tanespimycin as a treatment for patients with multiple myeloma. Through the FDA's Special Protocol Assessment (SPA) process, Kosan and the FDA have reached agreement on overall protocol design, primary efficacy endpoints and data analysis as well as aspects of expected labeling if the data from the pivotal trial are supportive and tanespimycin is approved by the FDA. This pivotal Phase 3 protocol, as well as the overall development program, have also completed the "Scientific Advice" process with the centralized European Medicines Agency (EMEA).

Kosan's registration program for tanespimycin, called Tanespimycin in Myeloma Evaluation or TIME, has been initiated and includes two clinical trials: TIME-1 and TIME-2. TIME-1 is a pivotal Phase 3 trial to be conducted in a first-relapse patient population. TIME-1 will evaluate the clinical benefit of adding tanespimycin to bortezomib and compare these results to those seen with single-agent bortezomib. The Special Protocol Assessment Kosan has completed applies to the TIME-1 trial. TIME-2, which is designed to be supportive of the TIME-1 trial, is a Phase 2/3 trial in patients with relapsed-refractory disease. The TIME-2 trial also has the potential to support registration in the relapsed-refractory setting. Kosan has initiated the TIME-2 trial, which is enrolling patients, and expects to init
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