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www.fdanews.com/articles/68720-kosan-initiates-phase-ii-trial-of-kos-862-for-prostate-cancer

Kosan Initiates Phase II Trial of KOS-862 for Prostate Cancer

February 14, 2005

Kosan Biosciences has begun a multicenter Phase II clinical trial to evaluate the safety and efficacy of KOS-862 (Epothilone D) as monotherapy for prostate cancer.

KOS-862 is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel, and preclinical models have shown the compound to be effective against paclitaxel-resistant tumors.

According to the Phase II trial design, KOS-862 will be administered weekly by intravenous administration for three of four weeks at a dose of 100 mg/m2. The trial is expected to enroll between 20 and 50 patients in hormone refractory patients who have progressed following treatment with a docetaxel-based regimen. Changes in prostate specific antigen and tumor response will be assessed to determine clinical activity.