April 24, 2013
/PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it is working with the National Football League Alumni Association (NFLAA), based in
, to develop a trial for treating NFL alumni members suffering from traumatic brain injuries (TBI), with NSI-189, the lead compound in the company's neurogenic drug platform. NSI-189, currently in a Phase Ib clinical trial to treat major depressive disorder (MDD), appears to work by stimulating neurons in the hippocampus, a region of the brain that atrophies in depression and which could also be implicated in brain injury. Neuralstem believes that pre-clinical work, in which NSI-189 stimulated new neuron formation in multiple animal models, as well as data from the current trial in humans, will be applicable to a potential study of NSI-189 in the treatment of TBI symptoms.
"The National Football League Alumni Association is focused on this serious health issue, which is destroying quality of life and has tragically led to several high-profile suicides just this past year among our members," said
, Chairman of the Board, Emeritus of the NFL Alumni Association, and former Green Bay Packer. "The NFL Alumni Association is excited to be working with Neuralstem on this cutting-edge technology. We are committed to pursuing both basic research into traumatic brain injury as well as pushing the envelope to create therapies that can improve the quality of life for our members afflicted with these diseases."
"We are very pleased to join with the NFL Alumni Association to work towards developing a treatment for traumatic brain injury among their members and others. Traumatic brain injuries have become the subject of increased public attention recently, especially with regard to both members of the military and football players," said
, Neuralstem's president and CEO. "These injuries can result in long-term and serious loss of cognitive function, depression, a shorter life span and, sadly, death by suicide in some cases. In addition to finding ways to better prevent such injuries, it is imperative that we provide new and improved ways to treat those with such neurological trauma."
NSI-189 is the first in a class of compounds that Neuralstem is developing into orally administered drugs. In mice, NS1-189 both stimulated neurogenesis of the hippocampus and increased its overall volume. Additionally, NS1-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in-vitro. Therefore, NS1-189 may reverse the human hippocampal atrophy seen in MDD and TBI. The NS1-189 pre-clinical program received significant support from both the
Defense Advanced Research Projects Agency
DARPA) and the National Institutes of Health (NIH).
About The NS1-189/Major Depressive Disorder Trial
The NS1-189/MDD Phase I trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NS1-189 in the treatment of MDD. Phase Ia tested escalating doses of single administration of NS1-189 in 41 healthy patients. Phase Ib is currently testing the safety of escalating doses of NS1-189 for 28 daily administrations in 24 depressed patients.