Healthcare Industry News: Dimebon
News Release - February 28, 2006
Medivation Exceeds Patient Enrollment Target in Phase 2 Alzheimer's Disease TrialSAN FRANCISCO--(HSMN NewsFeed)--Feb. 28, 2006--Medivation, Inc. (OTCBB:MDVN ) today announced that it has enrolled a total of 183 patients in its ongoing Phase 2 clinical trial of Dimebon to treat Alzheimer's disease, exceeding its projected enrollment target of 166 patients. The Company also announced it has closed enrollment of further patients into this study and, based on the study's twenty-six week dosing period, reaffirmed its prior forecast that the results of this study are scheduled to be announced in the third quarter of 2006.
David Hung, M.D., President and Chief Executive Officer of Medivation, stated: "Patient enrollment is a significant risk in conducting clinical trials; as such, we are particularly pleased not only to have met, but to have exceeded, our targeted patient enrollment in our Phase 2 Alzheimer's disease study. Our ability to enroll more than the targeted number of patients will increase the statistical power of this study. In addition, the achievement of this important milestone means we remain on track to deliver results from this trial as scheduled in the third quarter of this year."
Medivation, Inc. acquires promising pharmaceutical and medical device technologies in the late preclinical development phase, develops those technologies quickly and cost-effectively through human first proof-of-efficacy studies (generally the end of Phase 2 clinical trials), and seeks to sell or partner successful programs with larger pharmaceutical, biotechnology and medical device companies for late-stage clinical studies and commercialization. The Company intends to build and maintain a portfolio of 4 to 6 development programs at all times, targeting technologies with the potential to generate returns on investment of at least 6 fold within 3 years.
Medivation's current portfolio consists of small molecule drugs in development to treat 3 large, unmet medical needs - Alzheimer's disease, Huntington's disease and hormone-refractory prostate cancer, the last two of which are likely Orphan Drug indications. Dimebon(TM), with a 20-year record of human use and demonstrated efficacy in animal studies of both Alzheimer's disease (AD) and Huntington's disease (HD) and in a pilot clinical study of AD, is in a randomized, double-blind, placebo-controlled Phase 2 study in AD patients in Russia, the results of which are expected to be available in Q3 2006. Medivation also expects to initiate a U.S. Phase 1-2 study of Dimebon in HD patients in Q2 2006, and to receive the results of that study in Q4 2006. The MDVN 300 series compounds are scheduled to enter clinical development for the treatment of hormone-refractory prostate cancer by the end of 2006. Further information about Medivation can be found on its website (www.medivation.com).
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding the anticipated timing of regulatory and clinical milestones on the Company's Dimebon Alzheimer's disease and Huntington's disease programs, and the Company's MDVN300 family of small molecules for the treatment of hormone-refractory prostate cancer, 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. Our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2004 and our Quarterly Reports on Form 10-QSB for the quarters ended March 31, 2005, June 30, 2005, and September 30, 2005 include more information about factors that could affect our financial and operating results.
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