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Phase III Trial Initiated for XL119, Potential Treatment for Bile Duct Tumors

SOUTH SAN FRANCISCO, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Exelixis, Inc. announced that the company and the U.S. Food and Drug Administration (FDA) have reached agreement on the Phase 3 registration trial of XL119, its small molecule anticancer compound, via the Special Protocol Assessment process. Exelixis is currently undertaking activities leading to the initiation of the Phase 3 trial of XL119 as a potential treatment for bile duct tumors, with the goal of beginning the study in the first half of 2004.

The Special Protocol Assessment process creates a binding written agreement between the sponsoring company and the FDA concerning the design of pivotal clinical trials, clinical end points, study conduct, data analysis, and other clinical trial issues. The final approval of the compound requires demonstration of statistically significant efficacy and acceptable safety.

"We appreciate the opportunity to work collaboratively with the FDA to reach agreement on the Special Protocol Assessment and believe that the outcome of our discussions has been successful," said Jeffrey R. Latts, M.D., senior vice president and chief medical officer. "We continue to be encouraged by the potential of XL119 as a treatment for bile duct tumors, and intend to work expeditiously to initiate the Phase 3 trial in this indication. Based on the Special Protocol Assessment, the trial will be a randomized, well-controlled comparative study of XL119 in several hundred patients as a single-agent therapy with a survival-based endpoint. We plan to implement the Phase 3 clinical plan for XL119 either on our own or in collaboration with a potential development partner."

Earlier this year, safety and activity data presented at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO) from a Phase 2 trial in 33 patients with bile duct tumors (gall bladder tumors and cholangiocarcinomas) treated with XL119 showed encouraging results relative to overall survival and progression free survival. Data from a Phase 2 trial in 36 patients with non-small cell lung cancer were also presented, and showed encouraging results relative to survival as well.

Source: Exelixis, Inc.

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