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expected to continue in Phase 1 trials as a potential treatment for
gastrointestinal disorders.
"The reprioritization of our clinical portfolio to focus on our lead product candidates, tanespimycin and KOS-1584, strengthens our product focus and enables us to direct resources toward our highest potential value clinical programs," said Helen S. Kim, Kosan's President and Chief Business Officer. "We believe that tanespimycin and KOS-1584 are Kosan's most valuable near-term product opportunities. Tanespimycin is the most advanced Hsp90 inhibitor in clinical development and has the potential to be the first Hsp90 inhibitor to reach the market. We believe that developing KOS-1584 in non-small cell lung cancer, and advancing tanespimycin in breast cancer while we complete our TIME registration program in multiple myeloma, will be major value drivers for Kosan. We plan to continue to review our portfolio strategies with the goal of ensuring effective and efficient use of our resources."
Tanespimycin in Myeloma Evaluation (TIME) Registration Program on Track
The pivotal Phase 3 TIME-1 trial, the foundation of the tanespimycin registration program in multiple myeloma, is open and enrolling patients. TIME-1 is an open-label, randomized, multi-center, international trial that is designed to enroll approximately 470 patients with first-relapse disease. The TIME clinical program will utilize Kosan's improved, proprietary, injectable suspension formulation of tanespimycin. TIME-1 is designed with a primary endpoint of progression-free survival (PFS) and is designed to show a 2.75 month PFS benefit in patients treated with tanespimycin plus Velcade(R) (bortezomib) compared to patients treated with bortezomib alone.
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
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