воскресенье, 10 апреля 2011 г.

Medivation's Dimebon(TM) Significantly Improved Thinking And Memory In Alzheimer's Disease Patients Over One Year

Medivation, Inc. (Nasdaq: MDVN) announced that Alzheimer's patients
treated with the investigational drug Dimebon(TM) showed improvement in the
key aspects of cognitive function over a one-year period compared with
placebo. The improvement occurred in not only memory and language, but also
in more complex functions such as awareness of time and place, and praxis
-- the process of getting an idea and initiating and completing a new motor
task. These clinical results were generated during a pivotal trial of
Dimebon in patients with mild-to-moderate Alzheimer's disease (AD).


The data were presented during an oral presentation at the 60th
Annual Meeting of the American Academy of Neurology (AAN) by Steven H.
Ferris, Ph.D., the Gerald J. and Dorothy R. Friedman Professor of
Psychiatry at New York University and director of the NYU Alzheimer's
Disease Center.



"The finding that Dimebon improved memory, orientation, language and
praxis in Alzheimer's disease patients suggests that it provides a broad
rather than a selective cognitive benefit," said Dr. Ferris. "This is an
important finding given that deficits in memory and thinking are one of the
hallmarks of Alzheimer's disease and cause patients and caregivers
significant distress."



Dimebon Significantly Improved Cognitive Function at One Year



The data presented at the AAN Annual Meeting included results of an
analysis of the 11 subdomains of the Alzheimer's Disease Assessment
Scale-cognitive subscale (ADAS-cog), a standardized measure of cognition in
patients with AD and one of two endpoints the U.S. Food and Drug
Administration (FDA) has used to approve all currently marketed drugs for
mild-to-moderate AD. In the study, ADAS-cog 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 compared with placebo on 9 of the 11 ADAS-cog subdomains after one
year of treatment. Benefits were observed in memory (word recall, p=0.04;
word recognition, p=0.03; remembering instructions, p=0.10); orientation
(p= 0.01); constructional praxis (the ability to copy simple drawings or
patterns, p=0.005) and ideational praxis (the ability to perform a familiar
but complex sequence of actions, p=0.006); and language (following
commands, p








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 improved the clinical course of
Alzheimer's disease patients by causing statistically significant
improvements over placebo in each of the five primary aspects 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
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 medivation.



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.


Medivation, Inc.

medivation

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