Friday, December 17, 2010
Neuralstem Inc., of Rockville, Md., said the FDA approved its investigational new drug application for a Phase Ia trial of NSI-189, a small molecule designed to stimulate new neuron growth in the hippocampus for treating major depression. The study will test a single dose of the drug in healthy patients. If safety endpoints are met, the trial will move to a Phase Ib portion, testing the safety of escalating doses of daily administration for 28 days in depressed patients. The entire Phase I trial is expected to take about one year.
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