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http://biz.yahoo.com/prnews/031217/sfw089_1.html

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Exelixis Files IND Application for XL119

Wednesday December 17, 5:31 pm ET

SOUTH SAN FRANCISCO, Calif., Dec. 17 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL - News) has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) for XL119 (DEAE rebeccamycin), its lead proprietary anticancer compound. Under this new IND application, the company will sponsor and manage a Phase 3 clinical trial of XL119. Exelixis is currently undertaking activities leading to the initiation of the Phase 3 clinical trial of XL119 as a potential treatment for bile duct tumors, with the goal of beginning the study in the first half of 2004.

"XL119 represents a potential new treatment for bile duct cancer patients, and we are committed to moving expeditiously towards initiation of the Phase 3 clinical trial," said George A. Scangos, Ph.D., president and chief executive officer. "Bile duct tumors represent an unmet medical need, as currently there is no standard therapy for the approximately 30,000 patients worldwide diagnosed with this disease each year. The filing of the IND will help facilitate the advancement of XL119 into Phase 3 clinical trials, which we are eager to initiate. We also intend to continue to work with the NCI in planning additional Phase 2 exploratory studies of XL119 in various tumor types where the compound may demonstrate potential benefit."

In September of 2003, Exelixis reached an agreement with the FDA through the Special Protocol Assessment (SPA) process on the design of the XL119 Phase 3 clinical trial. Based on the SPA, 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.
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