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FDA Approves Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Major Depressive Disorder

ROCKVILLE, Md., April 22, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) 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." 

About NSI-189

Neuralstem's patented technology enables the creation of neural stem cell lines from many areas of the CNS, including the hippocampus. The hippocampus is a part of the brain involved in memory and the generation of new neurons. It is also implicated in several major neurological and psychiatric diseases. From its hippocampal neural stem cell lines, Neuralstem has created virtually unlimited amounts of mature neurons and glia in laboratory dishes. These can be used to mimic the natural brain environment in order to test drug effects.

Neuralstem has been engaged in a drug discovery program with these hippocampal stem cell lines since 2000. In 2009, Neuralstem was granted U.S. patents on four first-in-class chemical entities that boost the generation of new neurons. NSI-189, the first of these to be in a clinical trial, significantly stimulates the generation of new hippocampal neurons (neurogenesis) in vitro and in animal models.

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