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Medivation begins phase 1/2 trial of Dimebon for Huntington's disease, Alzheimer's disease extension trial
By Jennifer Lanning Drey
Portland, Ore., Oct. 19 - Medivation, Inc. has started a phase 1/2 clinical trial of Dimebon for Huntington's disease and a 12-month extension study of Dimebon for Alzheimer's disease, president and chief executive officer Dr. David Hung said at the 2006 BIO InvestorForum in San Francisco on Thursday.
"Our company is particularly focused on doing development as rapidly and cost effectively as possible," Hung told investors.
The company had cash of about $20 million at the end of June. Hung said the company's cash burn rate for the first six months of 2006 was roughly $900,000 per month.
The clinical trial of Dimebon for Huntington's disease will begin with a dose escalation phase that will be followed by a placebo-controlled, double-blinded randomized trial. The second portion of the trial will use the Unified Huntington's Disease Rating Scale as its primary efficacy score, Hung said.
Data from the trial is expected in the second half of 2007.
Medivation filed an Investigational New Drug Application in January for Dimebon for Huntington's disease and was told by the Food and Drug Administration in March that it needed to perform additional toxicology testing prior to human trials.
Hung also said on Thursday that Medivation will announce its projected registration plan for Dimebon for Alzheimer's disease in mid November.
The company has started a 12-month extension trial to its phase 2 clinical trial of Dimebon for Alzheimer's disease, and data from the extension study is expected in the second quarter of 2007, Hung said. The original phase 2 trial met all five of its efficacy points.
Hung said the company also plans to begin clinical trials of a new series of compounds for prostate cancer in 2007.
San Francisco-based Medivation acquires and develops pharmaceutical and medical device technologies.
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