Medivation Exceeds Patient Enrollment Target in Phase 2 Alzheimer's Disease Trial.SAN FRANCISCO -- Medivation, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :MDVN) today announced that it has enrolled a total of 183 patients in its ongoing Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of Dimebon to treat Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. , 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 To be announced (TBA) A contract for the purchase or sale of an MBS to be delivered at an agreed-upon future date but does not include a specified pool number and number of pools or precise amount to be delivered. 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." About Medivation 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 Huntington's disease, hereditary, acute disturbance of the central nervous system usually beginning in middle age and characterized by involuntary muscular movements and progressive intellectual deterioration; formerly called Huntington's chorea. and hormone-refractory prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. , the last two of which are likely Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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