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Medivation Completes Enrollment of Phase 1-2 Trial of MDV3100 in Castration-Resistant Prostate Cancer Patients
Date:12/17/2008

SAN FRANCISCO, Dec. 17 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that it has completed patient enrollment in a Phase 1-2 dose-escalation clinical trial of MDV3100, its novel androgen receptor antagonist, in castration-resistant prostate cancer patients, and that it will seek approval from the U.S. Food and Drug Administration (FDA) to advance to Phase 3 clinical trials next year.

The open-label, U.S. Phase 1-2 study evaluated prostate cancer patients who had failed standard hormonal therapies, including men who had also failed standard chemotherapy regimens. A total of 140 men were enrolled in the trial, which evaluated doses between 30 and 600 mg/day. Patients are being followed and may remain on treatment for as long as they continue to tolerate the drug and their disease does not progress.

Preliminary results of this trial, covering 73 treated patients in the 60, 150 and 240 mg/day dose groups, were presented in October at the 20th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The data showed encouraging and durable anti-tumor activity as measured by prostate specific antigen (PSA) declines, radiographic findings, circulating tumor cell (CTC) changes and time on treatment. These data also suggested a dose-response trend, with a higher percentage of patients in the 240 mg/day dose group experiencing 90 percent reduction in PSA levels, radiographic partial responses and conversions to favorable CTC counts of less than five post-treatment.

The Company expects to move into Phase 3 trials with either the 240 or the 360 mg/day dose, both of which have been generally well tolerated. The 480 mg/day dose did not have acceptable tolerability due to side effects, primarily fatigue. Efficacy data from the 360 mg/day dose group are under analysis and wil
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SOURCE Medivation, Inc.
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