Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat critically ill patients with serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers.
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Medivation has completed patient enrollment in an ongoing, open-label, U.S. Phase 1-2 clinical trial of MDV3100. The trial enrolled 140 patients with CRPC who had failed standard hormonal therapies, including those who had also failed standard chemotherapy regimens. Study endpoints included safety, tolerability, pharmacokinetics, effects on serum prostate-specific antigen (PSA) levels, a marker of tumor growth, and disease progression. Efficacy and safety data from this trial were presented in May 2009 at the American Society of Clinical Oncology’s 2009 Annual Meeting. Data presented showed that MDV3100 demonstrated anti-tumor activity across dose levels and a broad range of endpoints in both chemotherapy-naïve and post-chemotherapy patients. Click here for press release. Safety data, which included all 140 patients enrolled in the trial, showed MDV3100 to be generally well tolerated at doses up to and including 240 mg/day. The most frequently reported adverse event was fatigue. The Phase 3 AFFIRM trial is currently enrolling men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. Click here for press release. |
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