Rockville, Md. — Neuralstem, Inc., has been approved to dose the final cohort in the ongoing Phase Ia trial to test the safety of NSI-189 for the treatment of major depression. Phase Ia is testing the drug in healthy volunteers for safety and tolerability.
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 and conditions, such as Alzheimer's disease and post-traumatic stress disorder (PTSD).
"The trial is proceeding as expected," said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "There have been no adverse events to date. We are on schedule to complete Phase Ia in July, and with approval from the FDA, plan to begin Phase Ib this fall." Phase Ib will test the safety and tolerability of NSI-189 in patients with major depression.
NSI-189 is the lead compound in Neuralstem's neurogenerative small molecule drug platform, which the company plans to develop into orally administered drugs for major depression and other psychiatric disorders. It stimulated neurogenesis of human hippocampus-derived neural stem cells in-vitro.
In mice, NSI-189 stimulated neurogenesis in the hippocampus and increased its volume. In humans, NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).
This Phase Ia trial tests a single dose of NSI-189 in healthy patients. If the safety endpoints are met, the trial will commence to the Ib phase, testing the safety of escalating doses of daily administration for 28 days in depressed patients. The entire Phase I trial is expected to be approximately one year in duration.
Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia.
Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease and has been awarded orphan status designation by the FDA.
For more information, please go to www.neuralstem.com.