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FDA Approves Neuralstem to Treat Final Cohort in NSI-189 Phase Ib Trial

Mon, 04/22/2013 - 9:32am

Neuralstem, Inc. announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is a proprietary new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other diseases and conditions such as: traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).

"We are pleased to progress to the third and final cohort of this trial," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "The efficacy endpoints are all blinded until the conclusion of the trial, but the safety and tolerability of the compound, through the increased dosage in the first two cohorts, remains excellent."

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