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Phase II Clinical Trials of KOS-862 (Epothilone D) Evaluate Antitumor Activity

HAYWARD, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated announced today the start of multi-center Phase II clinical trials within the Kosan and Roche partnership to evaluate the efficacy of KOS-862 (Epothilone D) as a monotherapy for colorectal, non-small cell lung (NSCLC) and metastatic breast cancers. KOS-862 will be administered weekly for three of four weeks at a dose of 100 mg/m2.

"These multiple Phase II monotherapy clinical trials are designed to evaluate the antitumor activity and clinical benefit of KOS-862. In addition to these trials, the Kosan and Roche partnership will evaluate KOS-862 in Phase Ib combination studies with Gemzar®, Paraplatin®, Herceptin®, and Xeloda®," said Robert G. Johnson, Jr., M.D., Ph.D., Senior Vice President, Medical Affairs and Corporate Development and Chief Medical Officer, Kosan Biosciences.

Data related to the safety and tolerability of KOS-862, as well as preliminary evidence of antitumor activity from two Phase I clinical trials of KOS-862, including data from the recommended Phase II dose, were presented at the AACR-NCI-EORTC International Conference. The two posters were: "Phase I Dose Escalating and Pharmacokinetic (PK) Study of KOS-862 (Epothilone D): Phase II Dose and Schedule Defined" (abstract #A248) and "A Phase I Study to Determine the Safety and Pharmacokinetics of Continuous Intravenous Administration of KOS-862 (Epothilone D) in Patients with Solid Tumors" (abstract #A261).

KOS-862, partnered with Roche under a global development and commercialization agreement, is one of Kosan's two lead oncology programs. KOS-862 is a polyketide that inhibits cancer calls by the same mechanism a paclitaxel, and in preclinical models was shown to be effective against paclitaxel-resistant tumors.

Under the collaboration agreement between Kosan and Roche, Roche has the worldwide exclusive right to market and sell KOS-862 and epothilone D analogs owned by or licensed to Kosan for the treatment of cancer, and Kosan will co-develop and has the right to co-promote its epothilone D products in the U.S. for the treatment of cancer.

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