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

e assessment of the potential relationship between germline and/or tumor DNA sequence alterations and the efficacy of XL184, as well as assessment of pharmacodynamics and pharmacokinetics of XL184. It is expected that approximately 100 sites in 20 countries will participate in this study.

"We are very encouraged by the level of clinical activity in the ongoing XL184 phase 1 study showing a high response rate and durable disease control in medullary thyroid cancer patients, and believe that the FDA-approved phase 3 study design will allow us to rigorously evaluate the clinical benefit of XL184 in this population for which no standard of care is available," said Gisela Schwab, MD, executive vice president and chief medical officer at Exelixis.

The planned initiation of this phase 3 trial is based on encouraging data that were presented earlier this month at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO). Safety and clinical activity data were presented from an ongoing phase 1 trial of XL184 in 69 patients with various solid tumors, including 17 response-evaluable patients with MTC. These data showed a disease control rate (percentage of patients with partial responses or prolonged stable disease >3 months) of 100% in the evaluable MTC patients, with 53% of those patients (9 of 17) experiencing partial responses. The median duration of partial responses and stable disease for patients with MTC has not been reached (range 1+ to 22+ months). Most of the MTC patients in the trial had previously failed other treatments, including tyrosine kinase inhibitors with anti-RET activity (e.g., vandetanib, sorafenib, or motesanib), chemotherapeutic agents, immunotherapy, radioactive iodine, and radiotherapy.

Several additional studies with XL184 have recently been initiated to complement the planned pivotal trial in patients with MTC as part of Exelixis' strategy to rapidly advance compounds into areas of high unmet medical need whi
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SOURCE Exelixis, Inc.
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