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FDA authorizes Huntington’s disease study

US biotech firm Medivation has received permission from the FDA to begin a phase I-IIa clinical trial of Dimebon in patients with Huntington's disease.

Medivation expects patient dosing to begin in early October.

Dimebon has been shown to prevent the death of brain cells in preclinical models of Alzheimer’s disease and Huntington’s disease, making it a potential treatment for many neurodegenerative diseases.

Dimebon recently met all five efficacy endpoints in a trial of patients with mild to moderate Alzheimer’s disease. Patients in the trial were tested for a full spectrum of problems typically caused by Alzheimer’s disease, including memory loss, behavioral disturbances, and inability to perform everyday activities such as bathing and dressing.

After six months of treatment, patients on Dimebon got significantly better on all of these tests. Dimebon patients also scored significantly better on all of these tests than placebo patients.

Medivation is conducting the Huntington’s disease study in collaboration with the Huntington Study Group (HSG).

Medivation will submit additional animal studies to the FDA before beginning the second part of the clinical trial, and expects to report clinical trial results in the second half of 2007.