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 currently planned to enroll patients in 4 dose-expansion cohorts. Of the 21 patients treated at the lowest expanded dose of 60 mg/day evaluated at three months, 43 percent showed a >50 percent decline in PSA levels from baseline. The study endpoints include safety, tolerability, pharmacokinetics, effects on serum PSA levels and disease progression.
Medivation expects to complete the study, and report final top-line results, in 2008. If these results are positive, Medivation expects to seek U.S. Food and Drug Administration (FDA) agreement to enter pivotal Phase 3 registration study in castration-resistant prostate cancer.
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than 1 million men in the United States have prostate cancer. An estimated 186,320 new cases are expected to be diagnosed in 2008, and approximately 28,660 men are expected to die this year from the disease. Patients with castration-resistant (also known as hormone-refractory) prostate cancer have few treatment options and a poor prognosis.
Medivation, Inc. is a biopharmaceutical company with small molecule
drugs in clinical development to treat three large, unmet medical needs --
Alzheimer's disease, Huntington's disease and castration-resistant (also
known as hormone-refractory) prostate cancer. The Company's strategy is to
identify promising product candidates, to develop them in a rapid,
cost-effective manner, and to seek development and/or commercialization
|SOURCE Medivation, Inc.|
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