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 advanced prostate cancer 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 advanced 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. Long-term follow-up efficacy data from this trial, presented at the American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO-GU) in February 2011, showed that MDV3100 continues to demonstrate durable antitumor activity as evaluated by median times to PSA progression and radiographic progression. These findings confirm the initial results published in The Lancet. Click here for press release. The Phase 3 AFFIRM trial has completed enrollment of men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. The Phase 3 PREVAIL trial is currently enrolling men with advanced prostate cancer who have not yet received chemotherapy. Click here for press release. The Phase 2 TERRAIN trial, comparing MDV3100 with bicalutamide, is currently enrolling men who have progressed while on LHRH therapy or following surgical castration. Click here for press release. A Phase 2 trial evaluating MDV3100 monotherapy is currently enrolling hormone-naïve patients. Click here for press release. |
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