Medivation Begins Phase 1-2a Trial Of Dimebon(TM) In Huntington's Disease

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Oct 2006 - 0:00 PDT

email to a friend   printer friendly   view / write opinions

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.

Medivation, Inc
http://www.medivation.com