Endotis commences EP217609 Phase IIa study in patients undergoing open-heart surgery

Jun 22 2011

Endotis Pharma, a world leader in the development of neutralizable anticoagulants, today announced enrolment of the first patients into a Phase IIa study using EP217609 and its specific antidote avidin to manage coagulation during open-heart surgery. EP217609 has been specifically designed to provide surgeons with a safer, more predictable option than the current standard anticoagulant, heparin. Open-heart cardiac surgeries are often associated with potentially serious and costly complications, largely as a result of excessive bleeding caused by the surgery itself and by difficulties in managing the anticoagulation process.

"There is a great unmet need to safely and predictably manage blood circulation during cardiopulmonary bypass. The sole product available, heparin, is difficult to use and associated with many limitations and side effects. EP217609 is a unique product that we believe will offer surgeons and anesthetists a safer alternative that can quickly and permanently be reversed," explained Eric Neuhart, MD, Head of Clinical Research and Development at Endotis.

The Phase IIa proof-of-concept NOVEL study (Neutralizable anticOagulant eValuation in Extracorporeal circuLation) is designed to assess the safety and tolerability of EP217609 compared to heparin in 36 patients undergoing cardiac surgery. Endotis expects to release data from the study by the end of 2011.