>>ORLANDO, Fla.--(BUSINESS WIRE)--May 21, 2002--Kosan Biosciences Incorporated (NASDAQ:KOSN - News) announced today interim results from its initial clinical trial of KOS-862 (Epothilone D) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fla. Epothilones are polyketide natural products that inhibit cancer cells by the same mechanism as paclitaxel, and also are effective against paclitaxel-resistant tumors. The poster presentation entitled "KOS-862 (Epothilone D): Results of a Phase I Dose-escalating Trial in Patients with Advanced Malignancies" may be seen today from 8:00 a.m. to 11:00 a.m. in the Orange County Convention Center, Level 2, Hall C.
Kosan has two ongoing Phase I clinical trials of KOS-862 with a third trial expected to be initiated this year, each examining a different dosing regimen in patients with advanced solid tumors. As proven in the development of tubulin polymerizing agents, determination of the optimal dosing regimen is critical in the efficient development of drug candidates in this class. Today's presentation outlines interim results from the first of Kosan's Phase I clinical trials, which seeks to determine drug-related toxicity, pharmacokinetics and pharmacodynamics of escalating intravenous doses of KOS-862 administered every three weeks. To date, the trial has evaluated drug administration in seven dose escalations from 9 to 150 mg/m2. The results to date show KOS-862 is well-tolerated without dose limiting toxicities or myelosuppression. Pharmacokinetics are linear at the dose range tested to date, with dose-independent clearance, minimal inter-patient variability and stable upon repeat administration, all positive characteristics that contribute towards the rapid development of an anticancer agent. Pharmacodynamic measurements demonstrate dose-dependent biological activity of KOS-862 in peripheral blood cells in the form of tubulin stabilization. The predicted high dose based on preclinical studies has not been reached. Accordingly, dose escalation is continuing as planned. The clinical development program for KOS-862 remains on schedule for the initiation of Phase II testing during Q4/02 or Q1/03.<<
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