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Endotis Intiates Phase IIa Study of First-in-Class Neutralizable Anticoagulant in Open-Heart Surgery.

EP217609 has Potential to Replace Heparin as the Reversible Anticoagulant of Choice

PARIS -- 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.

Endotis to present at BIO 2011

Endotis will present its product pipeline and business strategy at the upcoming BIO2011 conference in Washington, D.C. on Wednesday, June 29 at 3:00 p.m. in the Capitol Hill room.

About Endotis Endotis Pharma is a world leader in the development of neutralizable anticoagulants used in cardiac surgery. The company's lead product, EP217609, is the first neutralizable anticoagulant to enter Phase II trials for managing extracorporeal blood circulation during open-heart surgery. Clinical studies to date show that EP217609 is well tolerated and has a predictable pharmacokinetic and pharmaco-dynamic profile, allowing precise control of the anticoagulation process. Endotis believes that EP217609 has the potential to reduce adverse events and the number of blood transfusions associated with open-heart surgery. The Endotis pipeline consists of innovative cardiovascular products based on validated targets and marketed compounds that target niche, high-value unmet medical needs. This strategy could mean relatively shorter development timelines. For further information visit www.endotis.com.
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Publication:Business Wire
Geographic Code:4EUFR
Date:Jun 22, 2011
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