SAN FRANCISCO and SAN DIEGO, April 14 Medivation, Inc. (Nasdaq: MDVN) today announced that data from an ongoingPhase 1-2 clinical trial showed that the Company's novel androgen receptorantagonist, MDV3100, continued to reduce serum levels of prostate specificantigen (PSA), a marker of tumor growth, in the lowest expanded dose grouptested after three months of treatment. Over-expression of the androgenreceptor is believed to contribute to the progression of castration-resistantprostate cancer. These observed declines were consistent with the inhibitionof androgen receptor signaling. MDV3100 continued to be well-tolerated in alldose groups.
The data were presented as part of a special late-breaker clinical plenarysession at the American Association for Cancer Research (AACR) Annual Meetingin San Diego. The oral presentation, entitled "Phase I-II study of theandrogen receptor antagonist MDV3100 in castration-resistant prostate cancer,"was presented by Howard Scher, M.D., chief of the Genitourinary OncologyService and the D. Wayne Calloway Chair in Urologic Oncology at MemorialSloan-Kettering Cancer Center in New York.
"The declines in PSA observed thus far and the general tolerability ofthis treatment are encouraging, and further data currently being generatedwill clarify its role as a potential therapy for patients withcastration-resistant prostate cancer," said Dr. Scher.
"We continue to be encouraged by the results observed at this low dose ofMDV3100. 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 isongoing. We look forward to providing additional results from this clinicaltrial at an upcoming medical conference."
The ongoing Phase 1-2 trial is an open-label U.S. study enrolling prostatecancer patients who have failed standard hormonal therapies. The study iscurrently planned to enroll patients in 4 dose-expansion cohorts. Of the 21patients treated at the lowest expanded dose of 60 mg/day evaluated at threemonths, 43 percent showed a >50 percent decline in PSA levels from baseline.The study endpoints include safety, tolerability, pharmacokinetics, effects onserum PSA levels and disease progression.
Medivation expects to complete the study, and report final top-lineresults, in 2008. If these results are positive, Medivation expects to seekU.S. Food and Drug Administration (FDA) agreement to enter pivotal Phase 3registration study in castration-resistant prostate cancer.
About Prostate Cancer
Prostate cancer is the most common non-skin cancer in the United Statesand the third most common cancer worldwide. More than 1 million men in theUnited States have prostate cancer. An estimated 186,320 new cases areexpected to be diagnosed in 2008, and approximately 28,660 men are expected todie this year from the disease. Patients with castration-resistant (alsoknown as hormone-refractory) prostate cancer have few treatment options and apoor prognosis.
Medivation, Inc. is a biopharmaceutical company with small molecule drugsin clinical development to treat three large, unmet medical needs --Alzheimer's disease, Huntington's disease and castration-resistant (also knownas hormone-refractory) prostate cancer. The Company's strategy is to identifypromising product candidates, to develop them in a rapid, cost-effectivemanner, and to seek development and/or commercialization partners asappropriate to complement its internal efforts. For more information, pleasego to http://www.medivation.com.
This press release contains forward-looking statements, includingstatements regarding anticipated clinical and regulatory milestones, which aremade pursuant to the safe harbor provisions of the Private Securities