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.
|
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. In April 2010, efficacy and safety data from this trial were published in The Lancet. According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed 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. A Phase 3 trial in men with castration-resistant prostate cancer who have not previously been treated with chemotherapy will begin enrolling patients in 2010. |
 |
 |
| Medivation © 2010 |