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Medivation and Astellas Announce Initiation of Phase 2 Clinical Trial Comparing MDV3100 With Bicalutamide

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Medivation, Inc. and Astellas Pharma Inc. have announced treatment of the first patient in the TERRAIN study, a Phase 2 comparison of the investigational drug MDV3100, a triple-acting oral androgen receptor antagonist, with bicalutamide, a commonly used anti-androgen, in the treatment of advanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration.

"MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than existing anti-androgens and the TERRAIN study provides the opportunity to investigate this finding further in a clinical setting," said Lynn Seely, M.D., chief medical officer of Medivation. "MDV3100 is currently in Phase 3 testing for advanced prostate cancer, but our goal is to determine if MDV3100 can benefit men with prostate cancer earlier in the course of the disease."

The TERRAIN Phase 2 trial is expected to enroll approximately 370 patients in North America and Europe. The primary endpoint of the trial is progression-free survival. Information about patient eligibility and enrollment can be obtained by calling 800-888-7704 ext. 5473 or e-mailing clintrials.info@us.astellas.com.

"This is the first of two Phase 2 trials in earlier-stage disease that we will initiate this year to evaluate the potential benefit of MDV3100 in a broad spectrum of prostate cancer patients," said Steven Ryder, M.D., president, Astellas Pharma Global Development. "The second of our new Phase 2 trials will study MDV3100 in an even earlier-stage population - hormone naïve prostate cancer patients who are indicated for androgen deprivation therapy. We expect to begin that trial in the first half of this year."