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Kosan Initiates Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer
Date:4/14/2008

HAYWARD, Calif., April 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced that the Phase 2 trial of epothilone KOS-1584 in patients with non-small cell lung cancer has been initiated. The Phase 2 trial is an open-label, multi-center, monotherapy study of KOS-1584 in patients with measurable advanced or metastatic non-small cell lung cancer who have previously received only one prior chemotherapy regimen. The primary endpoint of the Phase 2 trial is objective response rate. Secondary endpoints include progression-free survival, time to progression, time to treatment failure, time to response, duration of response and overall survival. KOS-1584 will be administered via a 3-hour intravenous infusion weekly for two weeks out of every three weeks at a dose of 25 mg/m(2). The Phase 2 trial will enroll up to 50 patients in a two-stage Simon design.

"We have been impressed by the breadth and level of activity and tolerability we have observed with KOS-1584 in our Phase 1 trials and believe that KOS-1584 has competitive potential in the emerging epothilone class of anticancer agents," said Helen S. Kim, Kosan's President and Chief Executive Officer. "Kosan's epothilone strategy is to advance KOS-1584 to its next inflection point while seeking a corporate partner to conduct a registration program and advance our preclinical product candidate, KOS-1803, into clinical development. We believe that KOS-1584's therapeutic profile and potential for near-term commercialization enhance its value for potential pharmaceutical collaborators."

KOS-1584 is a member of a class of cytotoxic macrolides (epothilones) capable of causing mitotic arrest by polymerization of cellular microtubules. Since microtubules
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SOURCE Kosan Biosciences Incorporated
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