ZZ Biotech begins Phase 1 clinical study to treat acute ischemic stroke
Houston-based ZZ Biotech, LLC has initiated a Phase 1 clinical study with 3K3A-APC to treat acute ischemic stroke.
The Phase 1 study is a randomized, double-blind, placebo-controlled, single-center trial that will investigate the safety and pharmacokinetics of single and multiple ascending doses of 3K3A-APC in healthy adult volunteers, the news reports said.
About 62 adults subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses.
The results of the study are expected in the first quarter of 2013.
“We are very pleased to have received the approval from the Austrian Agency for Health and Food Safety to initiate our first human study with 3K3A-APC,” said, Dr. Kent Pryor, Chief Operating Officer of ZZ Biotech. Mr. Pryor also said, “Our extensive preclinical studies into the neuroprotective effects of 3K3A-APC suggest that it is a promising candidate for the treatment of ischemic stroke.”
ZZ Biotech is a company based in Houston, TC. It develops innovative biological treatments for the aging and damaged brain, including those affected by stroke and other neurodegenerative disorders. 3K3A-APC is a genetically engineered variant of the naturally occurring activated protein C (APC) which plays a role in regulation of inflammation and blood clotting.