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Clinical Trial Update: Stem cell treatment for depression enters next trial phase

NSI-189, the lead compound in Neuralstem's small molecule platform, is a proprietary chemical entity that stimulates new neuron growth in the hippocampus. This region of the brain is involved in memory and the generation of new neurons and is believed to be implicated in MDD as well as other diseases and conditions such as Alzheimer's, anxiety and post-traumatic stress disorder.

Karl Johe, Ph.D, Neuralstem's Chief Scientific Officer, said, "We believe it could help patients who suffer from depression via a new mechanism that does not seek to modulate brain chemistry, but rather stimulates new neuron growth in the hippocampus and increases hippocampal volume, thereby potentially addressing the problem at the source."

This is the first time the drug will be tested in patients with MDD; Phase Ia was tested in healthy volunteers. The Phase Ib portion of the trial is expected to take approximately six months to complete.

Neuralstem's technology enables the creation of neural stem cell lines from many areas of the human central nervous system including the hippocampus. From its hippocampal neural stem cell lines, the company has created mature human neurons and glia in laboratory dishes. These can be used to mimic the natural brain environment to test drug effects.

Neuralstem has been engaged in a drug discovery program with these human hippocampal stem cell lines since 2000. In 2009, it 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, stimulates the generation of new hippocampal neurons in vitro and in animal models, Neuralstem says. The company hopes to use its findings to eventually develop orally administered drugs for MDD and other psychiatric and cognitive disorders.

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