SAN FRANCISCO and ORLANDO, Fla., March 15 /PRNewswire-FirstCall/ -- Medivation, Inc. today announced that clinical results from its first pivotal trial of Dimebon(TM) showed that behavioral symptoms were stabilized in patients with mild-to-moderate Alzheimer's disease (AD) over a one-year period, resulting in decreased caregiver distress. Benefits of Dimebon were seen across most behavioral symptoms and were most prominent in the symptoms of depression, apathy, hallucinations, irritability and motor disturbance (i.e., engaging in repetitive activities, such as pacing around the house). The data were presented today during a poster session on new research topics at the annual meeting of the American Association for Geriatric Psychiatry (AAGP) by Jeffrey Cummings, M.D., the Augustus Rose Professor of Neurology at the University of California, Los Angeles, and Director of the UCLA Alzheimer's Disease Center.
"These findings are noteworthy because behavioral symptoms are among the most difficult aspects of Alzheimer's disease that caregivers face, and often result in institutionalization of patients," said Dr. Cummings. "Given these behavioral data, together with the overall efficacy findings shown in the previously-reported Dimebon pivotal trial, I believe that Dimebon is one of the most promising Alzheimer's disease compounds in development."
Dimebon Improved NPI Score at Both Six Months and One Year
The data presented at the AAGP conference included results of an analysis of the 12 subdomains of the Neuropsychiatric Inventory (NPI), a measure of the behavioral symptoms of AD. During the study, the NPI was assessed at the beginning of the study and at weeks 12, 26, 39 and 52. Results showed that Dimebon-treated patients were significantly improved on the NPI total score compared with placebo-treated patients after six months (p=0.01) and one year of treatment (p=0.04). Dimebon treatment resulted in improvement over placebo on 8 of the 12 individual NPI subdomains.
Dimebon Reduced Caregiver Distress
Importantly, the behavioral improvements from Dimebon treatment resulted in a significant decrease in caregiver distress at 6 months (p=0.004) and at one year (p=0.04), compared to the distress of placebo patients' caregivers.
"Alzheimer's disease is a truly devastating disease, robbing patients of their mind and frequently causing significant behavioral problems, which dramatically impact the caregiver," said Lynn Seely, M.D., chief medical officer of Medivation. "There is a tremendous need for new drugs to treat this aspect of the disease, and we believe that Dimebon could provide an important new treatment option."
Dimebon Showed Statistically Significant Benefit Versus Placebo on All Key Efficacy Endpoints
Medivation previously announced efficacy and safety results from the pivotal, 12-month, double-blind, placebo-controlled trial of Dimebon in 183 patients with mild-to-moderate AD. Dimebon demonstrated statistically significant benefit versus placebo on all five efficacy endpoints at both six and 12 months. These endpoints spanned all of the most frequently studied aspects of Alzheimer's disease: cognition and memory, overall clinical function, activities of daily living and behavioral problems. Importantly, on every endpoint studied, the benefits of Dimebon over placebo at one year were stable or greater when compared to benefits at six months. No marketed drug for the treatment of Alzheimer's disease has shown this level of efficacy in published trials. Dimebon was well tolerated throughout the entire one-year treatment period. Significantly fewer serious adverse events were reported in the Dimebon group than in the placebo group at 12 months (p=0.03).
Medivation is planning to initiate a second, confirmatory pivotal Phase 3 trial of Dimebon in mild-to-moderate Alzheimer's disease in the second quarter of 2008 with the goal of completing the trial and applying for U.S. and European marketing approval in 2010. The Company is also evaluating Dimebon in an ongoing Phase 2 clinical trial in mild-to-moderate Huntington's disease. Dimebon is an orally-available small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's and Huntington's diseases, making it a potential treatment for these and other neurodegenerative diseases.
About Medivation
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 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.
