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Neuralstem Inc Receives Food and Drug Administration Approval For Neuralstem To Treat Final Cohort In NSI-189 Phase Ib Trial In Depressive Disorder


Monday, 22 Apr 2013 09:15am EDT 

Neuralstem Inc announced that it has received approval from the Food and Drug Administration (FDA) to begin dosing the third and final cohort of patients in its ongoing Phase Ib to test the safety of NSI-189 in the treatment of major depressive disorder (MDD). NSI-189, the lead compound in Neuralstem's neurogenic small molecule platform, is a new chemical entity that stimulates new neuron growth in the hippocampus, a region of the brain believed to be implicated in MDD, as well as other diseases and conditions such as: traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD). Neuralstem's patented technology enables the creation of neural stem cell lines from many areas of the CNS, including the hippocampus. The hippocampus is a part of the brain involved in memory and the generation of new neurons. It is also implicated in several neurological and psychiatric diseases. The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of MDD. Phase Ia, which was completed in October 2011, tested escalating doses of single administration of NSI-189 in 41 healthy patients. Phase Ib is testing the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients in three cohorts. This phase of the trial is expected to conclude in the third quarter of 2013. 

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