Endotis Pharma presents data on the neutralizable anticoagulant EP217609 and its specific antidote avidin in an extracorporeal circulation model
Biocitech Park, Paris (France), September 13th, 2010. Endotis Pharma announces that initial results* on the neutralizable anticoagulant EP217609 in a canine model of extracorporeal circulation (ECC) will be presented during today's session of the 24th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Geneva, Switzerland.
Both EP217609 and its specific antidote avidin were well tolerated in this animal study. A single intravenous dose of EP217609 resulted in efficient, stable anticoagulation throughout the ECC procedure. At the end of the ECC, the administration of intravenous avidin produced rapid, complete, irreversible neutralization without a rebound effect. There was no evidence of clotting in the extracorporeal circuit.
Eric Neuhart, MD, Head of Clinical Research and Development at Endotis Pharma, commented:
"These results in a clinically relevant animal model suggest that EP217609 and avidin could represent the first alternative to unfractionated heparin and its antidote protamine which, despite their known side effects and limitations, have been used during heart surgery for more than 50 years."
EP217609 is a first-in-class synthetic, parenteral anticoagulant which can be neutralized by a specific antidote avidin (EP5001). EP217609 has a dual mechanism of action which combines direct (free and clot-bound) thrombin inhibition and indirect factor Xa inhibition.
EP217609 and avidin are currently in Phase I clinical development. EP217609 has shown in healthy subjects a predictable and reproducible pharmacodynamic pharmacokinetic profile with low inter-subject variability. In June, Endotis announced that the neutralization of EP217609 by avidin will be assessed in healthy subjects in a Phase I clinical study, the results of which are expected by the end of this year
* EP217609, a novel neutralizable anticoagulant in cardiopulmonary bypass.
Y. Fromes1, E. Neuhart2, C. Krezel2, P. Gueret3, M. Petitou2. 1Institute of Myology, Pitié-Salpêtrière University Hospital - Department of Anesthesiology, St Joseph Hospital, Paris, France. 2Endotis Pharma, Romainville, France. 3Department of Hemostasis, Pontchaillou University Hospital, Rennes, France.