cts of the
disease -- memory, thinking, activities of daily living, behavior and
overall clinical function. Significant gains over placebo were evident
after as little as 12 weeks of treatment, and were maintained after both
six months and a full year of treatment. In addition, after six months of
treatment, Dimebon patients were significantly better on all five disease
aspects than they were at the beginning of the study. The real-world impact
of these data was evaluated by independent assessment, including caregiver
interviews, which confirmed improvement or stabilization in 81 percent of
Dimebon-treated patients after six months of treatment. Importantly,
Dimebon's overall benefit compared to placebo continued to increase over
time, and was larger at one year than at six months.
Dimebon was well-tolerated throughout the entire one-year treatment
period. The majority of adverse events were mild, with dry mouth (18.0
percent Dimebon, 1.1 percent placebo) and depressed mood the most common
events. There were significantly fewer serious adverse events in the
Dimebon group than in the placebo group at one year.
Medivation is planning to initiate a second, confirmatory pivotal Phase
3 trial of Dimebon in mild-to-moderate AD 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
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SOURCE Medivation, Inc. Copyright©2008 PR Newswire. All rights reserved | |
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