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

Stocks in this article: CUR

ROCKVILLE, Md., Oct. 17, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it has begun dosing the second 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: chronic traumatic encephalopathy (CTE), Alzheimer's disease, and post-traumatic stress disorder (PTSD).

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO)

"We are pleased that the second cohort of depression patients has begun treatment," said Karl Johe, PhD, Chairman of the Board and Chief Scientific Officer of Neuralstem "There were no adverse, clinically significant findings in vital signs, respiration rate, pulse, body temperature readings, blood/urine tests, ECG, EEG, C-SSRS, or MRI in the first cohort.  PK analysis showed the expected range of drug metabolism.  In short, there were no surprises.  The 40mg QD dose for 28 days was well-tolerated and safe.  I expect the same from the next dose group, 40mg BID for 28 days.  The efficacy data is, of course, blinded for all cohorts until the end of the trial."

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.

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