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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

is of safety and efficacy to be conducted based on predefined criteria. Kosan anticipates providing more information on the TIME-1 trial design upon initiation.

The TIME-2 clinical trial is being conducted at clinical sites primarily in the US and in Europe and is designed to enroll approximately 130 patients with relapsed-refractory multiple myeloma. The trial is designed to test three different doses of tanespimycin in combination with the approved dose and schedule of bortezomib (Velcade(R)) (1.3 mg/m2). The tanespimycin dose groups are 50 mg/m2, 175 mg/m2 and 340 mg/m2. Tanespimycin will be administered twice weekly as a one-hour intravenous infusion on a cycle of two weeks of treatment every three weeks (the same schedule as bortezomib). Patients eligible to participate in the TIME-2 trial must have been treated with and progressed following at least three prior treatments for multiple myeloma. Prior regimens must include bortezomib and lenalidomide (Revlimid(R)). The primary endpoint of the trial is the dose response based on objective response rate after 4 cycles of treatment. Secondary endpoints include a comparison of response rate between the three dose groups, progression-free survival, time to treatment failure and overall survival. Objective response rate in multiple myeloma is measured primarily by the patient's level of M protein.

About the Special Protocol Assessment

As stated in the Prescription Drug User Fee Act (PDUFA) and FDA's Guidance for Industry Special Protocol Assessment, "...having agreed to the design, execution, and analyses proposed in protocols reviewed under this process ... the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident. Thus, documented special protocol assessments should be considered binding on the review division and should not be changed at any time..." as
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SOURCE Kosan Biosciences Incorporated
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