Medivation, Inc. (Nasdaq:
MDVN) today announced treatment of the first patient in its Phase 2 trial
of Dimebon(TM) to treat Huntington's disease. Medivation has expanded
patient enrollment in the trial by 20 percent -- to 90 patients -- in order
to enhance the ability to detect differences between Dimebon and placebo.
"We are pleased that the results from the Phase 1 portion of our
Huntington's disease study allow us to move forward to the preliminary
efficacy phase," said David Hung, M.D., president and chief executive
officer of Medivation. "Given the robust efficacy and safety results
Dimebon achieved in our recently completed Alzheimer's disease trial, we
are excited about Dimebon's potential to benefit Huntington's disease
patients."
Medivation is conducting the Huntington's disease trial in
collaboration with the Huntington Study Group (HSG), a network of more than
250 experienced clinical trial investigators, coordinators and consultants
from more than 60 academic and research institutions throughout the United
States, Canada, Europe and Australia. The Phase 2 portion will be conducted
at approximately 17 HSG sites in the United States and Europe and is being
led by principal investigator Karl Kieburtz, M.D., M.P.H., professor of
neurology at the University of Rochester and director of the HSG Clinical
Trials Coordination Center.
The Phase 2 study is a randomized, placebo-controlled, double-blinded
evaluation of the safety and preliminary efficacy of Dimebon in 90
Huntington's disease patients after three-months of dosing. The primary
efficacy endpoint of the Phase 2 portion is the Unified Huntington's
Disease Rating Scale (UHDRS). Medivation expects to report study data in
the first half of 2008.
About Huntington's Disease
Huntington's disease is a progressive, neurodegenerative disease that
affects 30,000 patients in the U.S., with another 150,000 at risk. It is
caused by the death of specific brain cells and is characterized by the
gradual development of involuntary muscle movements, progressive
deterioration of cognitive processes and memory (dementia), and severe
behavioral disturbances. There are no drugs approved by the FDA to treat
this uniformly fatal genetic disorder.
About Dimebon
Dimebon is an orally-available small molecule that has been shown to
prevent the death of brain cells in preclinical models of Alzheimer's
disease and Huntington's disease, making it a novel potential treatment for
these and other neurodegenerative diseases. Based on the clinical and
preclinical data generated to date, Medivation believes that Dimebon
operates by a novel mechanism of action and may exert a neuroprotective
effect in multiple areas of the central nervous system. Dimebon appears to
block a new target that involves mitochondrial pores, which are thought to
play a role in the cell death that is associated with neurodegenerative
diseases and the aging process.
In a randomized, double-blinded, placebo-controlled trial of 183
patients with mild to moderate Alzheimer's disease, Dimebon-treated
patients were significantly improved over placebo on all five clinical
endpoints at 6 months, including cognition and memory, activities of daily
living, overall function, and behavior. Recently-announced results from
patients continuing this study showed that Dimebon sustained significant
improvement over placebo on every endpoint through one year of treatment.
Dimebon was well tolerated throughout the entire one-year period.
About Medivation
Medivation, Inc. is a biopharmaceutical company that acquires promising
technologies in the late preclinical development phase, and develops them
quickly and cost-effectively. Medivation's current portfolio consists of
small molecule drugs in development to treat three large, unmet medical
needs -- Alzheimer's disease, Huntington's disease and hormone-refractory
prostate cancer. The Company intends to build and maintain a portfolio of
four to six development programs at all times. For more information, please
go to medivation.
This press release contains forward-looking statements, including
statements regarding the anticipated timing of 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. You are also cautioned that none of the
Company's product candidates has been approved for sale, that significant
additional animal and human testing is required in order to seek marketing
approval for any of its product candidates, and that Medivation cannot
assure you that marketing approval can be obtained for any of its product
candidates. Medivation's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-KSB for the year ended
December 31, 2006, include more information about factors that could affect
the Company's financial and operating results.
Medivation, Inc.
medivation