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Kosan/Roche compound enters phase II prostate cancer trial

Kosan Biosciences has initiated a multi-center phase II clinical trial to evaluate the safety and efficacy of its Roche co-developed potential Taxol rival, KOS-862, in prostate cancer.

KOS-862 (Epothilone D) is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel (marketed as Taxol by Bristol-Myers squibb). Preclinical models have shown the compound to be effective against paclitaxel-resistant tumors.

The phase II trial follows encouraging data from preclinical and clinical trials to date and will evaluate the anti-tumor activity and clinical benefit of KOS-862 in prostate cancer.

The trial is expected to enroll between 20 and 50 hormone refractory patients who have progressed following treatment with a docetaxel-based regimen. Changes in prostate specific antigen (PSA) and tumor response will be assessed to determine clinical activity.

Under a global development and commercialization agreement between Roche and Kosan, Roche has the worldwide exclusive right to market and sell KOS-862 and epothilone analogs owned by or licensed to Kosan for the treatment of cancer.

Kosan will co-develop and has the right to co-promote Kosan/Roche epothilone products in the US for the treatment of cancer. The Roche-Kosan partnership’s clinical plans include evaluating KOS-862 in ongoing phase Ib combination studies with Eli Lilly’s Gemzar, Bristol-Myers Squibb’s Paraplatin and Genentech’s Herceptin and a phase II monotherapy trial in metastatic breast cancer.

Kosan is expecting interim data from the first stage of the phase II prostate cancer study in Q4 2005.