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Medivation Begins Phase II Dimebon Trial

Posted on: Tuesday, 31 July 2007, 06:19 CDT

Medivation says it has begun treatment of the first patient in its Phase II trial of Dimebon to treat Huntington's disease.

Medivation has expanded patient enrollment in the trial by 20% - to 90 patients - in order to enhance the ability to detect differences between Dimebon and placebo.

"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," said David Hung, president and CEO of Medivation.

Medivation is conducting the Huntington's disease trial in collaboration with the Huntington Study Group (HSG), a network of more than 250 clinical trial investigators, coordinators and consultants from more than 60 academic and research institutions throughout the US, Canada, Europe and Australia.

The Phase II portion will be conducted at approximately 17 HSG sites in the US and Europe and is being led by principal investigator Karl Kieburtz, professor of neurology at the University of Rochester and director of the HSG Clinical Trials Coordination Center.

The 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 II portion is the unified Huntington's disease rating scale. Medivation expects to report study data in the first half of 2008.

Source: Datamonitor

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