Medivation's MDV3100 Demonstrates Substantial PSA Reductions in First Patient Groups Treated in Phase 1-2 Hormone Refractory Prostate Ca...( - Early study data from the two lowe...),Health

- Early study data from the two lowest dose groups show dose-dependent PSA

declines to date in all patients -

- Conference call to be held today at 8:30 A.M. Eastern time -

SAN FRANCISCO, Nov. 5 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that its selective androgen receptor modulator, MDV3100, to date has reduced serum levels of prostate specific antigen (PSA), a marker of tumor growth, in the six patients enrolled in the first two dose groups of its ongoing Phase 1-2 trial in hormone refractory prostate cancer. PSA declines were seen in a dose-dependent manner in these patients. In the lowest dose group, after two months of treatment PSA levels declined 45 percent to 66 percent. PSA levels in the second lowest dose group declined 75 percent to 89 percent after the first month of treatment. MDV3100 has been well tolerated to date in both dose groups.

The ongoing Phase 1-2 trial is an open-label U.S. study enrolling prostate cancer patients who have failed standard hormonal therapies. The study is enrolling patients in up to seven dose groups of three patients each at escalating doses, with each group continuing treatment for at least three months barring any safety issues. The six patients enrolled to date comprise the two lowest dose groups, which to date have completed one and two months of treatment. Patient accrual for higher dose groups is ongoing. Once a maximum tolerated dose has been established, treatment at that dose level will be expanded to 20 patients. The study endpoints include safety, tolerability, pharmacokinetics, effects on serum PSA levels and disease progression.

"While these results are still preliminary, the declines
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