Neuralstem is a dual platform regenerative medicine company. The company’s technology enables the production of regionally specific, physiologically relevant neural stem cells for therapeutic use for the treatment of central nervous system (CNS) diseases and has enabled the discovery of a library of patented small molecule neurogenic compounds to treat psychological and cognitive disorders.
Neuralstem’s small molecule drug discovery program screens human neural stem cell lines for compounds that may stimulate neurogenesis in the brain, possibly reversing pathologies associated with certain CNS conditions. The company’s lead compound, NSI-189, has completed FDA Phase Ia and Ib safety trials for the treatment of major depressive disorder (MDD). Neuralstem is expecting to launch a Phase II study for MDD in 2015.
Neuralstem’s first stem cell therapy product, NSI-566, a spinal cord-derived neural stem cell line, is in ongoing clinical trials to treat amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease), for which it has received orphan status designation by the FDA. Dosing in a phase IIa trial was completed in July, 2014. The next trial is anticipated to commence in 2015. In addition to ALS, the company is conducting an NSI-566 Phase I trial in chronic spinal cord injury, with NSI-566 clinical development also underway to treat ischemic stroke.