News Feature | April 24, 2014

ZZ Biotech Announces NIH-Funded Phase II Trial For Stroke Drug

By Estel Grace Masangkay


ZZ Biotech announced that the National Institutes of Health and Broadview Ventures will support a multi-center Phase II clinical trial of its experimental drug 3K3A-APC in patients suffering from acute ischemic stroke.

The study will assess safety, activity, and tolerability of the 3K3A-APC when given after tissue plasminogen activator (tPA) in patients who have experienced moderately severe ischemic stroke.

Patrick Lyden, chair of the Department of Neurology at Cedars-Sinai, said, “There are few medical disorders that can have the sudden, potentially devastating consequences we often see with stroke. When treated quickly with the already-approved clot-busting drug tPA, the effects of many ischemic strokes can be reversed, but the time window of opportunity is short, and the treatment is not without risks. This study will help determine if the addition of 3K3A-APC can improve outcomes and reduce treatment side effects.” Chairman Lyden will be the principal investigator of the NIH-supported study in stroke patients. The study is expected to start patient recruitment across the country in the second half of this year.

3K3A-APC is a genetically engineered variant of activated protein C. The naturally activated protein plays a role in the regulation of blood clotting and inflammation. The drug helped prevent bleeding caused by tPA in animal models of stroke.

The NIH has awarded a clinical trial grant to Cedars-Sinai and a NeuroNEXT Infrastructure Resource Access award to ZZ Biotech. The company also received its first venture capital investment from Broadview Ventures, a philanthropic venture firm based in Boston focused on cardiovascular disease and stroke.

Joseph Romano, ZZ Biotech CEO, said, “We have been fortunate to have a wonderful group of investors dedicated to seeing us through the development of this important new potential drug for stroke, and we are pleased to welcome Broadview Ventures into our investor group. Funds provided by Broadview Ventures and NIH will allow us to conduct our first clinical study in actual stroke patients. We are gratified that both of these groups, each with discerning subject-matter experts in neurovascular disease treatments, recognize the potential of our drug to have a profound impact on the treatment of stroke.”