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FDA approves Neuralstem's NSI-189 for Phase Ib trial

December 29, 2011
by News release
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Neuralstem, Inc. announced that it has been approved by the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its neuroregenerative compound, NSI-189, for the treatment of major depressive disorder (MDD).

Phase Ib will test the safety and tolerability of the drug in depressed patients. 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 MDD as well as other diseases and conditions, such as Alzheimer's disease and post-traumatic stress disorder (PTSD).

"We are pleased to be approved to begin testing NSI-189 in patients who suffer from depression," said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "Loss of hippocampal volume is a known characteristic in depressed patients. NSI-189 stimulates neurogenesis and increases hippocampal volume in healthy adult mice, at the same time reversing behavioral symptoms in mouse depression models, so it could address depression at the source."

"It is exciting to see a new class of drugs that potentially offers a novel and different approach to this disease moving into patients," said Maurizio Fava, MD, Slater Family Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital. Dr. Fava, one of the world's leading researchers in MDD, helped design the Neuralstem trial.

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