SAN FRANCISCO and SAN DIEGO, April 14 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced that data from an ongoing Phase 1-2 clinical trial showed that the Company's novel androgen receptor antagonist, MDV3100, continued to reduce serum levels of prostate specific antigen (PSA), a marker of tumor growth, in the lowest expanded dose group tested after three months of treatment. Over-expression of the androgen receptor is believed to contribute to the progression of castration-resistant prostate cancer. These observed declines were consistent with the inhibition of androgen receptor signaling. MDV3100 continued to be well-tolerated in all dose groups.
The data were presented as part of a special late-breaker clinical plenary session at the American Association for Cancer Research (AACR) Annual Meeting in San Diego. The oral presentation, entitled "Phase I-II study of the androgen receptor antagonist MDV3100 in castration-resistant prostate cancer," was presented by Howard Scher, M.D., chief of the Genitourinary Oncology Service and the D. Wayne Calloway Chair in Urologic Oncology at Memorial Sloan-Kettering Cancer Center in New York.
"The declines in PSA observed thus far and the general tolerability of this treatment are encouraging, and further data currently being generated will clarify its role as a potential therapy for patients with castration-resistant prostate cancer," said Dr. Scher.
"We continue to be encouraged by the results observed at this low dose of MDV3100. In addition, we are testing higher doses to assess a dose response," said David Hung, M.D., president and chief executive officer of Medivation. "The analysis of the association between PSA declines and clinical outcomes is ongoing. We look forward to providing additional results from this clinical trial at an upcoming medical conference."
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 partners as appropriate to complement its internal efforts. For more information, please go to http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding anticipated clinical and regulatory milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. None of the Company's product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation's preclinical and clinical data, so its views remain subject to change. Medivation's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2007, include information about additional factors that could affect the Company's financial and operating results.
SOURCE Medivation, Inc.