Kosan Initiates Phase II Trial of KOS-862 (Epothilone D) for Prostate Cancer
14 February 2005, 07:30am ET
HAYWARD, Calif., Feb. 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN) announced today the start of a multi-center Phase II clinical trial to evaluate the safety and efficacy of KOS-862 (EpothiloneD) 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.
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.
About Kosan
Kosan Biosciences has two first-in-class anticancer agents in Phase II and Phase Ib clinical trials: KOS-862 (Epothilone D) and 17-AAG, a geldanamycin analog and Hsp90 inhibitor. KOS-862, the Company's lead drug candidate, has a mechanism of action similar to taxanes and is partnered with Roche in a global development and commercialization agreement, along with a follow-on compound, KOS-1584, currently in Phase I testing. 17-AAG targets multiple pathways required for tumor growth and is being developed in collaboration with the National Cancer Institute, in addition to a second-generation geldanamycin analog, DMAG, now in Phase I trials. Kosan's proprietary formulation of 17-AAG, KOS-953, is in Phase I and Phase Ib trials. Kosan has generated a pipeline of potentially significant products for cancer, infectious disease and other therapeutic areas based on its proprietary technologies for discovering, developing and manufacturing polyketide analogs. Polyketides are an important class of natural products that have yielded numerous pharmaceuticals for the treatment of cancer, infectious diseases, high cholesterol, transplant rejection and other diseases. For additional information on Kosan Biosciences, please visit the Company's website at kosan.com.
SOURCE Kosan Biosciences
Web Site: kosan.com |
