Date: 2011-06-22
Type of information:
phase: 2a
Announcement: initiation
Company: Endotis Pharma (France)
Product: EP217609 + avidin
Action mechanism: EP217609 has a dual mode of action combining the properties of an indirect factor Xa inhibitor and a direct thrombin inhibitor. It can be neutralized within a few minutes after administration of avidin.
Disease: management of coagulation during open-heart surgery
Therapeutic area: Cardiovascular diseases
Country:
Trial details: 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.
Latest news: Endotis Pharma has 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.
