ZZ Biotech, LLC have announced that it has commenced dosing healthy volunteers in a Phase 1 clinical study with 3K3A-APC, a recombinant variant of human activated protein C (APC), being developed for the treatment of 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. Approximately 62 eligible adult subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses. Results of the study are anticipated in the first quarter of 2013.
The foundation for 3K3A-APC was laid by scientific work conducted in laboratories at the University of Southern California and The Scripps Research Institute.
Dr. Kent Pryor, Chief Operating Officer of ZZ Biotech, commented: “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.”
Mr. Joseph Romano, Chief Executive Officer of ZZ Biotech, added: “Stroke is the No. 4 cause of death and the leading cause of adult disability in the United States. We are excited by the prospect of one day putting 3K3A-APC in doctors’ hands to help reduce the tremendous suffering caused by stroke.”
ZZ Biotech’s 3K3A-APC is a genetically engineered variant of the naturally occurring activated protein C (APC), which plays a role in the regulation of blood clotting and inflammation. APC has cell-protecting, anti-inflammatory and anti-coagulant properties; 3K3A-APC has reduced anti-coagulant ability, which minimizes the risk of bleeding induced by normal APC. In animal models of stroke, amyotrophic lateral sclerosis (ALS), neurotrauma, and sepsis, 3K3A-APC therapy has shown an advantage over recombinant APC in enhanced efficacy and reduced risk for bleeding. The protective effect of 3K3A-APC on the lining of blood vessels in the brain further helps prevent bleeding caused by tissue plasminogen activator (tPA), the only drug currently indicated for the treatment of acute ischemic stroke.
Source: ZZ Biotech, LLC