Kosan Initiates First KOS-862 Phase Ib Chemotherapy Combination Trial
Thursday March 4, 7:30 am ET
Roche/Kosan Collaboration to Initiate Additional Phase Ib Trials
HAYWARD, Calif., March 4 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) announced today the start of a Phase Ib clinical trial to evaluate KOS-862 (Epothilone D) as an anticancer therapy in combination with Gemzar® (gemcitabine HCl) in patients with advanced solid tumors. KOS-862 and Gemzar will be administered in a dose-escalating study designed to establish the maximum tolerated dose, pharmacokinetics, safety, and potential clinical benefit of the two drugs given in combination. Both KOS-862 and Gemzar will be given once weekly for three out of four weeks.
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"This is the first of several planned Phase Ib trials designed to evaluate KOS-862 in combination with standard chemotherapeutic regimens. In addition to the Phase Ib trial that Kosan is conducting, the Kosan/Roche partnership will evaluate KOS-862 in Phase Ib combination studies with Paraplatin® (carboplatin), Herceptin® (trastuzumab), and Xeloda® (capecitabine)," said Robert G. Johnson, Jr., M.D., Ph.D., Senior Vice President, Medical Affairs and Corporate Development and Chief Medical Officer, Kosan Biosciences.
The results of two preclinical studies evaluating KOS-862 and chemotherapeutic agents will be presented at AACR in March 2004 in Orlando, FL.
In December 2003, Kosan announced the start of multi-center Phase II clinical trials within the Kosan/Roche partnership to evaluate the efficacy of KOS-862 as monotherapy for colorectal, non-small cell lung (NSCLC) and metastatic breast cancers. KOS-862 is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel, and in preclinical models was shown to be effective against paclitaxel-resistant tumors. Under a global development and commercialization 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.
Kosan Biosciences has two lead clinical product candidates: KOS-862 and 17-AAG. Both compounds are derived from an important class of natural products known as polyketides. KOS-862 is in Phase II clinical trials and is part of the Roche global development and commercialization agreement. 17-AAG is being evaluated in multiple Phase I and Phase Ib clinical trials in collaboration with the National Cancer Institute. 17-AAG is a polyketide inhibitor of Hsp90 and interrupts several biological processes implicated in cancer cell growth and survival. By applying its expertise and proprietary technologies to generate polyketide analogs and by increasing the production yields of polyketides, Kosan has created a robust pipeline of potentially significant products for cancer, as well as for infectious disease and other therapeutic areas. For additional information on Kosan Biosciences, please visit the company's website at kosan.com . |
