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Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial
Date:6/16/2008

Pivotal Trial in Medullary Thyroid Cancer Planned to Initiate This Summer

SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) announced today that the company and the U.S. Food and Drug Administration (FDA) have reached agreement on the phase 3 registration trial of XL184, a small molecule anticancer compound targeting MET, RET, and VEGFR2, via the Special Protocol Assessment process. Exelixis has also discussed the trial design with European regulatory agencies. Exelixis is planning to initiate the phase 3 trial of XL184 as a potential treatment for medullary thyroid cancer (MTC) this summer.

The phase 3 trial has been designed in collaboration with internationally renowned experts in the field of thyroid malignancies, including Dr. Steven Sherman from the MD Anderson Cancer Center in Houston, Texas, Drs. Douglas Ball and Barry Nelkin from Johns Hopkins University in Baltimore, Maryland, and Dr. Martin Schlumberger from the Institut Gustave Roussy in Paris, France. This will be a randomized, placebo-controlled, double-blinded study of XL184 as single-agent therapy in 315 patients with unresectable, locally advanced, or metastatic MTC. Patients will be randomized in a 2:1 ratio to receive XL184 or placebo administered as a daily oral dose. The primary endpoint will be duration of progression-free survival. In a planned event-driven analysis, the study size provides 90% power to detect a 75% increase in progression-free survival in patients with documented progressive disease prior to study entry. Secondary endpoints will include overall survival, objective tumor response rate, and changes in serum biomarkers (carcinoembryonic antigen and calcitonin). Additional secondary endpoints will b
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SOURCE Exelixis, Inc.
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