NSI-189 IND Application for Treatment of Depression, Neuralstem (AMEX:CUR)
CUR has filed an Investigational New Drug (IND) application with the FDA to begin 2 Phase I safety trials to test NSI-189, its 1st small molecule compound, for the treatment of major depression.
- NSI-189 is a proprietary new chemical entity discoveredthat stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression;
- 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;
- CUR believes 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;
- NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in- vitro;
- In mice, NSI-189 both stimulated neurogenesis of the hippocampus and increased its overall volume as well;
- NSI-189 may reverse the human hippocampal atrophy seen in major depression and schizophrenia;
- The 1st trial will involve testing the safety of escalating doses of a single administration ;
- The 2nd trial is designed to test the safety of escalating doses of daily administration for 28 days in depressed patients;
- The entire trial is expected to be approximately 1 year in duration.
This is significant milestone and could represent the next generation of antidepressant treatment based on a new mechanism of action that affects complex stem cell biology rather than a single molecular target.
- This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).
Categories: NSI-189 IND Application, Stem Cell Technology
