The TIME clinical program will utilize Kosan's improved, proprietary injectable suspension formulation of tanespimycin injectable suspension. The 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-2 clinical trial is being conducted at clinical sites primarily in the US and in Europe and is anticipated to enroll approximately 130 patients. Key aspects of the TIME-2 trial are as follows.
-- The trial is designed to test three different doses of tanespimycin in
combination with the approved dose and schedule of bortezomib
(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
-- 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 dose
groups, progression-free survival, time to treatment failure and
overall survival. Objective response rate in multiple myeloma is
measured primarily by the pa
|SOURCE Kosan Biosciences Incorporated|
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