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. The company commenced an FDA-approved Phase II NSI-566 clinical trial for ALS in September 2013, and has been FDA-approved to commence a Phase I NSI-566 safety clinical trial for chronic spinal cord injury (cSCI). Neuralstem is targeting additional major CNS conditions with its cell therapy platform, including ischemic stroke and Huntington’s disease.
Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some CNS conditions. The company completed an FDA-approved Phase I trial evaluating NSI-189, its lead neurogenic small molecule drug, for the treatment of major depressive disorder, in 4Q13 with data showing clinically meaningful improvement across all depressive and cognitive measures. A Phase II NSI-189/MDD trial is expected to commence in 2014. Additional indications could include traumatic brain injury, Alzheimer's disease and pre-Alzheimer’s dementia, and post-traumatic stress disorder (PTSD).