The researchers found that, under those conditions, tPA therapy alone caused bleeding in the brain and did not reduce brain damage or improve motor ability when compared to the control. The combination of tPA and 3K3A-APC, however, reduced brain damage by more than half, eliminated tPA-induced bleeding and significantly improved motor ability.
"Scientists all around the globe are studying potential stroke therapies, but very few have the robust preclinical data package that 3K3A-APC has," said Kent Pryor, Ph.D., M.B.A., ZZ Biotech's chief operating officer. "The results from Dr. Zlokovic's studies have been very promising."
Zlokovic's team previously reported similar results in young, healthy male rodents. A Phase 1 trial testing the safety of 3K3A-APC in healthy human volunteers, led by study co-author Patrick D. Lyden, M.D., of Cedars-Sinai, concluded in February.
"We now have opened an investigational new drug application at the FDA to conduct a Phase 2 clinical trial of 3K3A-APC in patients experiencing acute ischemic stroke," said Joe Romano, CEO and president of ZZ Biotech. "We are excited to see 3K3A-APC move from healthy volunteers to real patients suffering from this terrible disease."
|Contact: Alison Trinidad|
University of Southern California - Health Sciences