Neuralstem files NSI-189 IND with FDA for Phase I safety trials for major depression

Neuralstem, Inc. (NYSE Amex: CUR) announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin two Phase I safety trials to test NSI-189, its first small molecule compound, for the treatment of major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression.

"This marks more than just a significant milestone for the company: we believe our compound represents the next generation of antidepressant treatment based on a new mechanism of action that may, for the first time, fundamentally modify the disease," said Neuralstem President & CEO Richard Garr. "NSI-189 also validates Neuralstem's proprietary neural stem cell screening approach as a source for discovering novel compounds that affect complex stem cell biology rather than a single molecular target."

"The antidepressants that are available today are based on the theory of serotonin deficiency," explained Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "NSI-189 is based on a new theory that chronic exposure to stress hormones can inhibit the growth of new neurons in certain regions of the brain. This can lead to hippocampal atrophy and depression. We believe that this neurogenic approach to brain self-repair may be applicable in multiple diseases including: Alzheimer's disease, mild cognitive impairment, dementia, schizophrenia, cognitive complications from diabetes, post-traumatic stress syndrome and traumatic brain injury, all of which are indications that the company intends to pursue with this new class of drugs."