Berislav Zlokovic, MD, PhD, director of the Zilkha Neurogenetic Institute at the Keck School of Medicine of USC, will co-lead a multicenter Phase 2 clinical trial of an experimental drug developed in his lab to treat patients suffering from acute ischemic stroke.
Zlokovic, who is a co-investigator on the study, is a co-founder of ZZ Biotech Scientific, which is making the drug, known as 3K3A-APC.
The Phase 2 study will evaluate safety, tolerability and activity of 3K3A-APC when given after tissue plasminogen activator, or tPA, in patients who have experienced moderately severe ischemic stroke. The drug will be given intravenously as a 15-minute infusion every 12 hours for up to five treatments, and four dose levels will be evaluated. About 100 participants, ages 18 to 80, will be followed for 90 days.
The experimental drug is a genetically engineered variant of the naturally occurring activated protein C, which plays a role in the regulation of blood clotting and inflammation. In animal models of stroke, 3K3A-APC has helped prevent bleeding caused by tPA, the only drug currently indicated for the treatment of acute ischemic stroke.
Zlokovic said, “From the beginning, our intent has been to bring promising scientific discoveries from the laboratory bench to the patient bedside, where they have the most impact. We are pleased to have this opportunity to continue our work in translational medicine and save more lives.”
ZZ Biotech was founded in 2006 by Zlokovic and financier and philanthropist Selim Zilkha, and has been funded to date by private investors and a Qualifying Therapeutic Discovery Project grant.