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Phase 2 Trial Evaluates Safety and Efficacy of Epothilone D as Monotherapy for Prostate Cancer
"Based on encouraging data from preclinical and clinical trials, we are initiating a Phase II monotherapy trial to evaluate the antitumor activity and clinical benefit of KOS-862 in prostate cancer patients," said Robert G. Johnson, Jr., M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer, Kosan Biosciences. "In the fourth quarter of 2005, we expect to be able to take an interim look at data acquired during the first stage of the study."
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 (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 U.S. for the treatment of cancer. The Roche-Kosan partnership's clinical plans include evaluating KOS-862 in ongoing Phase Ib combination studies with Gemzar(R), Paraplatin(R) and Herceptin(R) and a Phase II monotherapy trial in metastatic breast cancer.
Source: Kosan Biosciences Incorporated