The National Football League Alumni Association (NFLAA) and Neuralstem Inc. are working together to develop a trial using one of the company’s drugs to treat retired football players suffering from traumatic brain injuries (TBI).
In a press release Wednesday, the two announced that the trial would incorporate 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,” the press release said.
Rockville, Md.-based Neuralstem maintains 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,” Lee Nystrom, Chairman of the Board, Emeritus of the NFL Alumni Association, and a former Green Bay Packer, said in a statement.
“The NFL Alumni Association is excited to be working with Neuralstem on this cutting-edge technology,” he said. “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.”
Richard Garr, Neuralstem’s president and CEO, also touted the trial.
“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,” Garr said.
“Traumatic brain injuries have become the subject of increased public attention recently, especially with regard to both members of the military and football players,” he said. “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, according to the company.
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. herefore, 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).