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news.Clinical-stage drug developer Migenix has received approval from Health Canada to begin a phase I/II human clinical study with MX-4509, a compound in development for the treatment of neurodegenerative diseases.
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MX-4509 is an orally-administered drug candidate being developed for the treatment of neurodegenerative diseases. It was well tolerated in a phase I clinical trial and has demonstrated neuroprotective activity in cellular and animal models of neuroprotection.
The phase I/II study will be a placebo controlled double-blinded study assessing the effect of MX-4509 on oxidative stress markers, as well as assess the safety and tolerability of the compound in approximately 14 patients with mild to moderate Alzheimer’s disease.
The study is being conducted in Alzheimer’s patients to assess the ability of MX-4509 to moderate oxidative stress. Oxidative stress has been associated with the pathogenesis of Alzheimer’s disease, Friedreich’s ataxia, Parkinson’s disease and other neurodegenerative diseases.
The study is planned to start mid-2005 with results from the study expected in the fourth quarter of 2005.