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"The significant, rapid onset PSA declines experienced to date by our first six hormone refractory prostate cancer patients treated with MDV3100 mark an auspicious beginning to this trial," said David Hung, MD, president and chief executive officer of Medivation. "These declines occurred in a clearly dose-dependent manner at the lowest doses of MDV3100 tested, which suggests that higher doses may produce even greater PSA declines."
"It is important to consider these data in their proper context," continued Dr. Hung. "These PSA reductions are early data from a small number of patients. We do not yet know whether they will be confirmed at the end of the study, and even if they are confirmed we do not know if PSA reductions will correlate with an improvement in overall survival, the standard registration endpoint used in most pivotal Phase 3 studies for hormone-refractory prostate cancer. Nonetheless, we believe these early data provide strong proof of concept for MDV3100, and we eagerly await additional study data from these first two groups as well as from the higher dose groups still to come."
Medivation expects to complete the study, and report final top-line study results, in 2008. If these results are positive, Medivation expects to seek U.S. Food and Drug Administration (FDA) agreement in 2008 to enter pivotal Phase 3 registration studies in hormone refractory prostate cancer.
Teleconference/Webcast
Medivation will host a teleconference at 8:30 a.m. Eastern time today
to discuss the data. To participate in the live call by telephone, please
dial
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