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Neuralstem gets FDA approval for NSI-189 trial

Neuralstem said that the US Food and Drug Administration (FDA) has approved its investigational new drug (IND) application to initiate a Phase Ia safety trial to test NSI-189, its first small molecule compound, in major depression.

NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus.
Neuralstem president and CEO Richard Garr said that the commencement of the first trial in the small molecule platform represents a major milestone for Neuralstem.

"In addition to our ongoing programs in cell therapeutics, we are now advancing a new class of orally administered drugs that recruit endogenous neural stem cells," Garr said.