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Neuralstem's NSI-189 trial in major depressive disorder receives FDA approval to advance to Phase Ib
Date:12/27/2011

has created virtually unlimited amounts of mature human 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 its own drug discovery program with these human 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, above and beyond the neural stem cells' innate differentiation.

NSI-189 is the lead compound in Neuralstem's neuroregenerative small molecule drug platform, which the company plans to develop into orally administered drugs for MDD and other psychiatric disorders, such as Alzheimer's disease, anxiety, bipolar disorder and post traumatic stress disorder.

NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in-vitro. In healthy normal adult mice, NSI-189 stimulated neurogenesis in the hippocampus and significantly increased its volume, apparently by increasing its synaptic network after 28 days of daily oral administration. In mouse models of depression, NSI-189 significantly improved behavioral responses associated with depression. In humans, NSI-189 may reverse the human hippocampal atrophy seen in MDD and other disorders and reverse their symptoms. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).

About the Trial

The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of MDD. Phase Ia tested escalating doses of single administration of NSI-
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Contact: Deanne Eagle
deanneeagle@gmail.com
917-837-5866
Neuralstem, Inc.
Source:Eurekalert

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