Public release date: 8-Aug-2012 [ | E-mail | Share ]
Contact: Mika Ono mikaono@scripps.edu 858-784-2052 Scripps Research Institute
LA JOLLA, CA, August 8, 2012 Clinical trials start this week for a stroke drug initially created by a team led by scientists at The Scripps Research Institute and the University of Southern California (USC), and further developed by biotech company ZZ Biotech.
The clinical trials will test the safety in humans of the experimental drug 3K3A-APC, which has been shown in animal models to reduce brain damage and improve motor skills after stroke when given in conjunction with a federally approved clot-busting therapy.
"I am incredibly excited about the potential for translating our science into a therapy that could have a significant impact on society," said Scripps Research Institute Professor John Griffin, who collaborated on the scientific work with Professor Berislav V. Zlokovic, director of the Zilkha Neurogenetic Institute at the Keck School of Medicine of USC. "Stroke and its aftereffects are a huge problem in this country."
Kent Pryor, chief operating officer of ZZ Biotech, said, "We are very pleased to have received approval from The Austrian Agency for Health and Food Safety (AGES) to initiate our first human study with 3K3A-APC. Our extensive preclinical studies into the neuroprotective effects of 3K3A-APC suggest that it is a promising candidate for the treatment of ischemic stroke."
Fourth-Leading Cause of Death
Stroke, which occurs when blood flow to a part of the brain stops, is the fourth-leading cause of death and the leading cause of adult disability in the United States. A stroke occurs when blood flow in the brain is interrupted, cutting off part of the brain from oxygen. Some brain damage happens immediately, but even when blood flow is restored, brain cells continue dying for hours or days.
According to the American Stroke Association, the Food and Drug Administration-approved tPA (tissue plasminogen activator) is the best treatment for stroke caused by a blocked artery, but to be effective, it must be administered within three hours after symptoms start. If given outside that three-hour window, tPA has shown serious side effects in animal and human brains, including bleeding and breakdown of the brain's protective barrier.
Generally, according to the American Stroke Association, only three to five percent of those who suffer a stroke reach the hospital and satisfy relevant criteria in time to be considered for tPA treatment.
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Clinical trials start for stroke drug developed by Scripps Research, USC, and ZZ Biotech