Neuralstem, Inc., developer of patented technology with the ability to produce neural stem cells of the human brain and spinal cord, yesterday announced that the U.S. Food and Drug Administration (FDA) has given its approval for an Investigational New Drug (IND) application to initiate a phase Ia safety trial to test NSI-189, Neuralstem’s first small molecule compound for major depression.

Discovered by Neuralstem, NSI-189 is the first in a family of compounds that Neuralstem said it plans to develop into orally administered drugs. The compound stimulates neuron growth in an area of the brain believed to be associated with 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,” Richard Garr, Neuralstem president and CEO stated in the press release. “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.”

Neuralstem’s phase Ia trial will test a single dose of NSI-189 in healthy patients to meet specific safety endpoints. If those endpoints are met, the company will move forward with phase Ib to test the safety of escalating doses of daily administration for 28 days in depressed patients. The entire phase I trial is expected to last approximately 12 months.

Karl Johe, PhD, chief scientific officer and chairman of Neuralstem’s board of directors, explained the importance and potential of NSI-189.

“Today’s antidepressants are based on a theory of serotonin deficiency,” Johe stated. “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.”

For more information visit www.neuralstem.com

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