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NSI-566 is in a Phase I trial to test the safety of the cells and procedure in the treatment of amyotrophic lateral sclerosis (ALS or
Lou Gehrig's disease). The last patient was treated in August, 2012. Neuralstem was recently approved to commence a NSI-566 trial in stroke in
China, through its Chinese subsidiary, Neuralstem China, and has submitted an IND to the FDA to commence a trial in spinal cord injury with the same cells in the U.S.
NSI-144, NSI-150, NSI-158 and NSI-189 are small molecule, orally active compounds that stimulate new neuron growth in the hippocampus. NSI-189 is currently in a Phase Ib clinical trial testing its safety for the treatment of major depressive disorder (MDD).
The titles and schedule for Neuralstem's poster presentations at Neuroscience 2012 are:
"Survival and Differentiation of Human Neural Stem Cells (NSI-566RSC) After Grafting into Ischemia-Injured Porcine Brain," S.Wu et. al., University of California, San Diego, Poster #59.14/L20 - Saturday, October 13, 2:00-3:00, Hall F-J
"Histopathological Assessment of Adult Ischemic Rat Brains After Intracerebral Transplantation of NSI-566RSC Cell Line," K.L. Hayama et. al., University of South Florida, Poster # 59.15/M1 - Saturday, October 13, 3:00-4:00, Hall F-J
"Decreased Tau Phosphorylation by AMPK Activation in Cortical Neurons," B. Kim et. al., University of Michigan, Poster # 220.08 - Sunday, October 14, 2:45-3:00, Location: 395
"A Study to Examine the Tumorgenicity of Human Neural Stem Cell Line NSI-566RSC in Spinal Cord Injured Rats," T. Lam et. al., University of California, San Diego, Poster #450.17/K7 - Monday, October 15, 1:00-2:00. Hall F-J
NSI-144, NSI-150, NSI-158 and NSI-189
"Histological Assessment of Mouse Brains After 28-Day Chronic Oral Administration of Four Novel Neurogenic Compounds," D. Lee et. al, Poster # 664.20/X1 - Tuesday, October 16, 4:00 – 6:00, Hall F-J.
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 has recently treated the last patient 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.
In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in spinal cord injury.