Medivation Begins Phase 1-2a Trial of Dimebon(TM) in Huntington's Disease
19 October 2006 - 11:00PM
PR Newswire (US)
Company to Present at BIO InvestorForum 2006 Today at 9:40 a.m.
Pacific Time SAN FRANCISCO, Oct. 19 /PRNewswire-FirstCall/ --
Medivation, Inc. (AMEX:MDV) today announced that patient dosing has
begun for its Phase 1-2a clinical trial of Dimebon(TM) to treat
Huntington's disease. "The initiation of our first clinical trial
in Huntington's disease represents an important clinical milestone
for Medivation and our second clinical indication for Dimebon,"
said David Hung, M.D., president and chief executive officer of
Medivation. "Given the robust efficacy and safety results observed
in our recently completed Alzheimer's disease clinical study of
Dimebon, 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 study will be conducted at
approximately 12 HSG sites in the United States and 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 Huntington's disease
clinical trial has two parts: a dose-escalation phase to determine
the optimal doses of Dimebon, followed by a three-month randomized,
placebo-controlled, double-blinded phase to evaluate the safety and
preliminary efficacy of those doses in approximately 75
Huntington's disease patients. The second part of the study will
begin after additional animal toxicology studies, requested by FDA
and now underway, have been completed. The primary efficacy
endpoint in the trial is the Unified Huntington's Disease Rating
Scale (UHDRS), and results are expected in the second half of 2007.
About Dimebon Dimebon has been shown to prevent the death of brain
cells (neurons) in preclinical models of Alzheimer's disease and
Huntington's disease, making it a novel potential treatment for
many neurodegenerative diseases. In a six- month randomized,
double-blinded, placebo-controlled trial of 183 patients with mild
to moderate Alzheimer's disease, Dimebon met all five clinical
endpoints with strong statistical significance and was very well
tolerated. Medivation and its advisors designed this study to match
closely the design of pivotal registration studies previously
accepted by the FDA to approve currently marketed Alzheimer's
disease drugs, including duration of treatment, clinical endpoints
and patient inclusion/exclusion criteria. BIO InvestorForum 2006
Presentation Today at 9:40 a.m. Pacific Time, Medivation's Dr. Hung
will present at the BIO InvestorForum 2006 at the Palace Hotel in
San Francisco. The presentation will include an overview of
Medivation and its Dimebon program for Alzheimer's disease and
Huntington's disease, as well as additional data from the Company's
recently completed Alzheimer's disease clinical trial. A live audio
webcast of the presentation will be available on the Company's
website at http://www.medivation.com/, and a replay will also be
available for 30 days following the live presentation. 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 http://www.medivation.com/. This press release contains
forward-looking statements, including statements regarding the
anticipated timing of regulatory and clinical milestones on the
Company's Huntington's disease program, 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 have 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, 2005, and its
Quarterly Reports on Form 10-QSB for the quarters ended March 31,
2006, and June 30, 2006, include more information about factors
that could affect the Company's financial and operating results.
DATASOURCE: Medivation, Inc. CONTACT: Patrick Machado, Chief
Financial Officer of Medivation, Inc., +1-415-543-3470, ext. 201;
or Jani Bergan of WeissComm Partners, +1-415-946-1064, for
Medivation Web site: http://www.medivation.com/
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