News
22/06/2011
Endotis Pharma initiates phase IIa study of first-in-class neutralizable anticoagulant in open-heart surgery
Biocitech Park, Paris, France, June 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.
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.
Contacts:
Endotis Pharma Halsin Partners
Denis Henrard Mike Sinclair
Head of Business Development & Licensing Partner
+33 (0) 1 48 46 50 52 +44 (0)20 7318 2955
denis.henrard@endotis.com msinclair@halsin.com
Biocitech Park, Paris, France, June 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.
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.
Contacts:
Endotis Pharma Halsin Partners
Denis Henrard Mike Sinclair
Head of Business Development & Licensing Partner
+33 (0) 1 48 46 50 52 +44 (0)20 7318 2955
denis.henrard@endotis.com msinclair@halsin.com
15/11/2010
Endotis Pharma reports successful completion of the neutralization study ofthe anticoagulant EP217609 by avidin in healthy subjects
Biocitech Park, Paris (France), November 15th, 2010. Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs (SGDs) for applications in thrombosis and hemato-oncology, announced that it has successfully completed the first study assessing in healthy subjects the neutralization of the anticoagulant EP217609 by its specific antidote avidin. EP217609 and avidin were well tolerated in the 36 healthy subjects enrolled in this study.
A single intravenous bolus of EP217609 achieved a stable anticoagulation during 90 minutes, then the subsequent administration of avidin triggered a rapid, complete, and irreversible neutralization of the anticoagulant activity of EP217609 without rebound effects. EP217609 is a first-in-class synthetic, parenteral anticoagulant that can be neutralized by a specific antidote avidin (EP5001). EP217609 has a dual mechanism of action combining direct (free and clot-bound) thrombin inhibition and indirect factor Xa inhibition.
Eric Neuhart, MD, Head of Clinical Research and Development at Endotis Pharma, commented: ?This study confirms the data generated in previous studies performed in healthy subject and animals. EP217609 and avidin have a predictable and reproducible pharmacodynamic and pharmacokinetic profile with a low inter-subject variability. ? Eric Neuhart added: EP217609 and avidin will be developed in extracorporeal circulation for cardiac surgery as a first indication. EP217609 and avidin could represent the first alternative to replace heparin and its antidote protamine, used for more than 50 years in cardiac surgery despite their limitations and side effects. The data generated during phase I clinical studies will allow the optimization of the phase II clinical program that will be initiated in cardiac surgery patients in the first half of 2011?.
About Endotis Pharma (www.endotis.com) Endotis Pharma is a biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis, oncology and hematology. Endotis has developed a breakthrough thrombosis franchise of parenteral and oral drugs in clinical and preclinical development, and a promising oncology and hematology discovery platform. Endotis has 32 employees based in Paris and Lille, France. Disclaimer: The development of new drug technologies is difficult, erratic and unpredictable. Endotis Pharma?s forecasts and future economic performance depend on research that has yet to be performed and on a number of other factors. The company's future economic performance may differ significantly from that currently forecast
For more information
Press contact: Alize RP
Caroline Carmagnol
+33 (0)6 64 18 99 59
caroline@alizerp.com
Endotis Pharma contact:
Denis Henrard
Head of Business Development and Licensing
denishenrard@endotis.com
+33 (0) 1 48 46 50 52
Biocitech Park, Paris (France), November 15th, 2010. Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs (SGDs) for applications in thrombosis and hemato-oncology, announced that it has successfully completed the first study assessing in healthy subjects the neutralization of the anticoagulant EP217609 by its specific antidote avidin. EP217609 and avidin were well tolerated in the 36 healthy subjects enrolled in this study.
A single intravenous bolus of EP217609 achieved a stable anticoagulation during 90 minutes, then the subsequent administration of avidin triggered a rapid, complete, and irreversible neutralization of the anticoagulant activity of EP217609 without rebound effects. EP217609 is a first-in-class synthetic, parenteral anticoagulant that can be neutralized by a specific antidote avidin (EP5001). EP217609 has a dual mechanism of action combining direct (free and clot-bound) thrombin inhibition and indirect factor Xa inhibition.
Eric Neuhart, MD, Head of Clinical Research and Development at Endotis Pharma, commented: ?This study confirms the data generated in previous studies performed in healthy subject and animals. EP217609 and avidin have a predictable and reproducible pharmacodynamic and pharmacokinetic profile with a low inter-subject variability. ? Eric Neuhart added: EP217609 and avidin will be developed in extracorporeal circulation for cardiac surgery as a first indication. EP217609 and avidin could represent the first alternative to replace heparin and its antidote protamine, used for more than 50 years in cardiac surgery despite their limitations and side effects. The data generated during phase I clinical studies will allow the optimization of the phase II clinical program that will be initiated in cardiac surgery patients in the first half of 2011?.
About Endotis Pharma (www.endotis.com) Endotis Pharma is a biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis, oncology and hematology. Endotis has developed a breakthrough thrombosis franchise of parenteral and oral drugs in clinical and preclinical development, and a promising oncology and hematology discovery platform. Endotis has 32 employees based in Paris and Lille, France. Disclaimer: The development of new drug technologies is difficult, erratic and unpredictable. Endotis Pharma?s forecasts and future economic performance depend on research that has yet to be performed and on a number of other factors. The company's future economic performance may differ significantly from that currently forecast
For more information
Press contact: Alize RP
Caroline Carmagnol
+33 (0)6 64 18 99 59
caroline@alizerp.com
Endotis Pharma contact:
Denis Henrard
Head of Business Development and Licensing
denishenrard@endotis.com
+33 (0) 1 48 46 50 52
15/11/2010
Endotis Pharma annonce les résultats positifs de l'essai clinique de neutralisation de l'anticoagulant EP217609 par l'avidine chez le sujet sain
Parc Biocitech, Paris (France), le 15 novembre 2010. Endotis Pharma, société biopharmaceutique spécialisée dans la découverte et le développement d`oligosaccharides de synthèse (« small-glyco drugs ») pour des applications dans le domaine de la thrombose et de l`hémato-cancérologie, annonce aujourd`hui les résultats positifs de l`essai clinique de neutralisation de l`anticoagulant EP217609 par son antidote spécifique l`avidine chez le sujet sain.
L`EP217609 et l`avidine ont été bien tolérés chez les 36 sujets sains recrutés dans cette étude. Une injection unique d`EP217609 a permis d`assurer une anticoagulation stable pendant 90 minutes, puis l`administration ultérieure d`avidine a permis une neutralisation rapide, complète et irréversible de l`activité anticoagulante d`EP217609 sans effet rebond. EP217609 est un anticoagulant synthétique parentéral -premier de sa classe thérapeutique- qui peut être neutralisé par un antidote spécifique l`avidine(EP5001). EP217609 possède un double mécanisme d`action combinant une inhibition directe de la thrombine (libre et liée au caillot) et indirecte du facteur Xa.
Le Dr Eric Neuhart, responsable de la Recherche et du Développement Clinique chez Endotis Pharma, déclare : « Cette étude confirme les données obtenues précédemment chez les volontaires sains et les animaux. EP217609 et l`avidine ont un profil pharmacodynamique et pharmacocinétique prédictibles et reproductibles avec une faible variabilité interindividuelle. » Eric Neuhart ajoute : «EP217609 et l`avidine seront développés comme première indication dans la circulation extracorporelle chez les patients bénéficiant d`une intervention de chirurgie cardiaque. EP217609 et l`avidine pourraient représenter la première alternative à l`héparine non fractionnée et son antidote, la protamine, qui sont utilisés en chirurgie cardiaque depuis plus de 50 ans malgré leurs limites et effets secondaires. Les données obtenues durant les études de phase I permettront d`optimiser le programme de phase II qui sera initié chez des patients de chirurgie cardiaque pendant le premier semestre 2011».
A propos d`Endotis Pharma (www.endotis.com) Endotis Pharma est une société de spécialités pharmaceutiques dédiée à la découverte et au développement de sucres synthétiques ou « small-glyco drugs » pour des applications dans les domaines de la thrombose, du cancer et de l`hématologie. Endotis a développé un portefeuille innovant dans le domaine de la thrombose, constitué de composés administrables par voie parentérale ou orale qui sont en développement clinique ou préclinique; ainsi qu`une plateforme de recherche prometteuse en oncologie et hématologie. Endotis emploie 32 personnes à Paris et à Lille (France). Déclaration de mise en garde : le développement de nouvelles technologies thérapeutiques est difficile, irrégulier et imprévisible. Les prévisions d`Endotis Pharma et les performances économiques futures dépendent de travaux de recherche qui n`ont pas encore été réalisés et d`un certain nombre d`autres facteurs. Les performances économiques futures de la société peuvent être significativement différentes de celles qui sont actuellement anticipées. Pour plus de renseignements :
Contact presse : Alize RP
Caroline Carmagnol
+33 (0)6 64 18 99 59
caroline@alizerp.com
Anne-Sophie Cosquéric
+ 33 (0)1 42 68 86 41
anne-sophie@alizerp.com
Contact Endotis Pharma :
Denis Henrard
Directeur du Business Développement
denishenrard@endotis.com
+33 (0) 1 48 46 50 52
Parc Biocitech, Paris (France), le 15 novembre 2010. Endotis Pharma, société biopharmaceutique spécialisée dans la découverte et le développement d`oligosaccharides de synthèse (« small-glyco drugs ») pour des applications dans le domaine de la thrombose et de l`hémato-cancérologie, annonce aujourd`hui les résultats positifs de l`essai clinique de neutralisation de l`anticoagulant EP217609 par son antidote spécifique l`avidine chez le sujet sain.
L`EP217609 et l`avidine ont été bien tolérés chez les 36 sujets sains recrutés dans cette étude. Une injection unique d`EP217609 a permis d`assurer une anticoagulation stable pendant 90 minutes, puis l`administration ultérieure d`avidine a permis une neutralisation rapide, complète et irréversible de l`activité anticoagulante d`EP217609 sans effet rebond. EP217609 est un anticoagulant synthétique parentéral -premier de sa classe thérapeutique- qui peut être neutralisé par un antidote spécifique l`avidine(EP5001). EP217609 possède un double mécanisme d`action combinant une inhibition directe de la thrombine (libre et liée au caillot) et indirecte du facteur Xa.
Le Dr Eric Neuhart, responsable de la Recherche et du Développement Clinique chez Endotis Pharma, déclare : « Cette étude confirme les données obtenues précédemment chez les volontaires sains et les animaux. EP217609 et l`avidine ont un profil pharmacodynamique et pharmacocinétique prédictibles et reproductibles avec une faible variabilité interindividuelle. » Eric Neuhart ajoute : «EP217609 et l`avidine seront développés comme première indication dans la circulation extracorporelle chez les patients bénéficiant d`une intervention de chirurgie cardiaque. EP217609 et l`avidine pourraient représenter la première alternative à l`héparine non fractionnée et son antidote, la protamine, qui sont utilisés en chirurgie cardiaque depuis plus de 50 ans malgré leurs limites et effets secondaires. Les données obtenues durant les études de phase I permettront d`optimiser le programme de phase II qui sera initié chez des patients de chirurgie cardiaque pendant le premier semestre 2011».
A propos d`Endotis Pharma (www.endotis.com) Endotis Pharma est une société de spécialités pharmaceutiques dédiée à la découverte et au développement de sucres synthétiques ou « small-glyco drugs » pour des applications dans les domaines de la thrombose, du cancer et de l`hématologie. Endotis a développé un portefeuille innovant dans le domaine de la thrombose, constitué de composés administrables par voie parentérale ou orale qui sont en développement clinique ou préclinique; ainsi qu`une plateforme de recherche prometteuse en oncologie et hématologie. Endotis emploie 32 personnes à Paris et à Lille (France). Déclaration de mise en garde : le développement de nouvelles technologies thérapeutiques est difficile, irrégulier et imprévisible. Les prévisions d`Endotis Pharma et les performances économiques futures dépendent de travaux de recherche qui n`ont pas encore été réalisés et d`un certain nombre d`autres facteurs. Les performances économiques futures de la société peuvent être significativement différentes de celles qui sont actuellement anticipées. Pour plus de renseignements :
Contact presse : Alize RP
Caroline Carmagnol
+33 (0)6 64 18 99 59
caroline@alizerp.com
Anne-Sophie Cosquéric
+ 33 (0)1 42 68 86 41
anne-sophie@alizerp.com
Contact Endotis Pharma :
Denis Henrard
Directeur du Business Développement
denishenrard@endotis.com
+33 (0) 1 48 46 50 52