Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study in Huntington... (red in19% of treated patients compared t...)

Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study in Huntington's Disease

Date:7/7/2008

red in 19% of treated patients compared to 7% of placebo patients. Headaches were generally mild in severity. Dry mouth and depressed mood were similar in both treated and placebo groups (4% and 7%, respectively).

"To my knowledge, no other drug has resulted in statistically significant benefit in cognition in Huntington's disease patients in a randomized, well-controlled trial," said Karl Kieburtz, M.D., M.P.H., professor of neurology at the University of Rochester, director of the HSG Clinical Trials Coordination Center, and principal investigator in this trial. "Cognitive impairment is the most important therapeutic unmet need in Huntington's disease. I am pleased by this result and Dimebon's favorable safety profile, and believe that further development of this compound is warranted."

The randomized, double-blinded, placebo-controlled Phase 2 trial was conducted at 16 centers in the United States and the United Kingdom 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 dedicated to clinical research of Huntington's disease. The trial enrolled 90 HD patients, with half randomized to Dimebon and the other half to placebo for a three-month dosing period. The primary endpoint of the trial was safety and tolerability. The secondary endpoint was efficacy, as measured by the MMSE, the UHDRS and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), a cognition scale generally used in Alzheimer's disease clinical trials.

"We are very encouraged that Dimebon improved cognition and was well tolerated in both trials assessing efficacy that we have conducted to date -- this trial and our first pivotal trial in Alzheimer's disease. The consistency seen in the data between these two trials underscores the potential for this dru
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Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study in Huntington...(red in19% of treated patients compared t...),Health