FDA approves Neuralstem's IND to initiate NSI-189 Phase Ia safety trial in major depression

Neuralstem, Inc. (NYSE Amex: CUR) today announced that the U.S. 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, an area of the brain that is believed to be involved in depression and other diseases, such as Alzheimer's disease.

"The commencement of the first trial in our small molecule platform represents a major milestone for Neuralstem," said Richard Garr, Neuralstem President & CEO. "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.  NSI-189 is the first in this class."

"Today's antidepressants are based on a theory of serotonin deficiency," explained Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "A new theory is emerging that chronic stress can lead to hippocampal atrophy and eventually to depression. NSI-189 appears to help the brain repair itself, generating new neurons and protecting against damage. This neurogenic approach is completely novel in the treatment of CNS diseases."