Publications
13/07/2010
Endotis Pharma presents Phase I clinical trial resultsfor a first-in-class synthetic parenteral neutralizable anticoagulant EP217609at the 21st International Congress on Thrombosis
Biocitech Park, Paris (France), July 8th, 2010 - Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, announced that Phase I clinical trial results1 for EP217609 will be presented on July 8th at the 21st International Congress on Thrombosis (ICT) in Milan, Italy.
EP217609 is a first-in-class synthetic, parenteral anticoagulant which can be neutralized by a specific antidote, avidin. EP217609 has a dual mechanism of action, which combines direct free and clot-bound
thrombin inhibition and indirect factor Xa inhibition.
In this first Phase I study, EP217609 was well tolerated in 24 healthy subjects exposed to single, ascending doses. As expected, administration of EP217609 resulted in dose-dependent increases in
standard and specific coagulation tests and, a decrease in thrombin generation. EP217609 pharmacodynamic and pharmacokinetic profiles were predictable, with low inter-subject variability.
1 Presentation title: First human study with EP217609, a new synthetic parenteral neutralizable dual action anticoagulant.
P. Gueret1, C. Krezel2, P. L. M. van Giersbergen3, E. Fuseau4, M. Petitou2, E. Neuhart2.
1Hemostasis Department, Pontchaillou University Hospital Rennes, France. 2Endotis Pharma, Romainville, France.
3Van Giersbergen Consulting, Wuenheim, France. 4EMF Consulting, Aix en Provence, France
Biocitech Park, Paris (France), July 8th, 2010 - Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, announced that Phase I clinical trial results1 for EP217609 will be presented on July 8th at the 21st International Congress on Thrombosis (ICT) in Milan, Italy.
EP217609 is a first-in-class synthetic, parenteral anticoagulant which can be neutralized by a specific antidote, avidin. EP217609 has a dual mechanism of action, which combines direct free and clot-bound
thrombin inhibition and indirect factor Xa inhibition.
In this first Phase I study, EP217609 was well tolerated in 24 healthy subjects exposed to single, ascending doses. As expected, administration of EP217609 resulted in dose-dependent increases in
standard and specific coagulation tests and, a decrease in thrombin generation. EP217609 pharmacodynamic and pharmacokinetic profiles were predictable, with low inter-subject variability.
1 Presentation title: First human study with EP217609, a new synthetic parenteral neutralizable dual action anticoagulant.
P. Gueret1, C. Krezel2, P. L. M. van Giersbergen3, E. Fuseau4, M. Petitou2, E. Neuhart2.
1Hemostasis Department, Pontchaillou University Hospital Rennes, France. 2Endotis Pharma, Romainville, France.
3Van Giersbergen Consulting, Wuenheim, France. 4EMF Consulting, Aix en Provence, France
13/07/2010
Endotis Pharma presents data on the neutralizable anticoagulant EP217609 in an extracorporeal circulation model
Biocitech Park, Paris (France), June 3rd, 2010. Endotis Pharma announced that initial results* on the neutralizable anticoagulant EP217609 in a canine model of extracorporeal circulation (ECC) will be presented today, at the French Society of Thoracic and Cardiovascular Surgery's 63th annual meeting in Tours, France. Both EP217609 and its specific antidote avidin were well tolerated in this clinically relevant animal study. A single dose of EP217609 resulted in efficient, stable anticoagulation throughout the ECC procedure. Subsequent administration of avidin produced rapid, complete, irreversible neutralization and no rebound effect. There was no evidence of clotting in the extracorporeal circuits.
* EP217609, a new neutralizable anticoagulant for cardiopulmonary bypass during cardiac surgery. 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.
Biocitech Park, Paris (France), June 3rd, 2010. Endotis Pharma announced that initial results* on the neutralizable anticoagulant EP217609 in a canine model of extracorporeal circulation (ECC) will be presented today, at the French Society of Thoracic and Cardiovascular Surgery's 63th annual meeting in Tours, France. Both EP217609 and its specific antidote avidin were well tolerated in this clinically relevant animal study. A single dose of EP217609 resulted in efficient, stable anticoagulation throughout the ECC procedure. Subsequent administration of avidin produced rapid, complete, irreversible neutralization and no rebound effect. There was no evidence of clotting in the extracorporeal circuits.
* EP217609, a new neutralizable anticoagulant for cardiopulmonary bypass during cardiac surgery. 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.
16/04/2010
Endotis Pharma presents Phase I clinical trials results for EP42675 at ASH
Biocitech Park, Paris (France), December 4, 2009 - Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, today announced that Phase I clinical trial results for EP42675* will be presented on December 6, 2009 at the 51st Annual meeting of the American Society of Hematology congress (ASH) in New
Orleans, Louisiana, USA.
In May of this year, Endotis announced that EP42675 had successfully completed its Phase I program. In October, the company then announced the initiation of a Phase I program with EP217609, the biotinylated neutralizable form of EP42675, and its specific antidote, avidin. EP42675 and EP217609 are the first representatives of a new class of synthetic, parenteral, antithrombotic drugs with a dual mechanism of action combining the properties of an indirect factor Xa inhibitor and a direct thrombin inhibitor. Furthermore, EP217609 can be neutralized within a few minutes by the administration of avidin.
EP42675 was well tolerated in 100 healthy subjects enrolled in five Phase I studies, including single-dose and multiple ascending dose trial designs and a pharmacodynamic interaction study with a combination of
oral aspirin and clopidogrel. Treatment with EP42675 resulted in dose-dependent increases in standard and specific coagulation tests and a decrease in thrombin generation. EP42675 showed predictable
pharmacokinetic (PK) and pharmacodynamic (PD) profiles, with a low intra- and inter-subject variability.
In animals, the PK/PD profiles of EP217609 and EP42675 are similar.
On the basis of EP42675 data, an optimized Phase I program has been defined for EP217609, with a view to quicker entry into Phase II in two target indications: extracorporeal circulation in cardiac surgery and
percutaneous coronary intervention in acute coronary syndromes.
The overall clinical development strategy for EP217609 and its antidote avidin has been endorsed by key national Health Authorities throughout Europe and by the Food and Drug Administration in the USA.
Phase I results with EP217609 and avidin are expected in early 2010.
* EP42675, a new dual-action anticoagulant: pharmacodynamic and pharmacokinetic profile, and
interactions with acetylsalicylic acid, clopidogrel, and unfractionated heparin. Pierre Gueret, Chantal
Krezel, Paul van Giersbergen, Eliane Fuseau, Thierry Lamy and Eric Neuhart.
Biocitech Park, Paris (France), December 4, 2009 - Endotis Pharma, the biopharmaceutical company dedicated to the discovery and development of small-glyco drugs for applications in thrombosis and
oncology, today announced that Phase I clinical trial results for EP42675* will be presented on December 6, 2009 at the 51st Annual meeting of the American Society of Hematology congress (ASH) in New
Orleans, Louisiana, USA.
In May of this year, Endotis announced that EP42675 had successfully completed its Phase I program. In October, the company then announced the initiation of a Phase I program with EP217609, the biotinylated neutralizable form of EP42675, and its specific antidote, avidin. EP42675 and EP217609 are the first representatives of a new class of synthetic, parenteral, antithrombotic drugs with a dual mechanism of action combining the properties of an indirect factor Xa inhibitor and a direct thrombin inhibitor. Furthermore, EP217609 can be neutralized within a few minutes by the administration of avidin.
EP42675 was well tolerated in 100 healthy subjects enrolled in five Phase I studies, including single-dose and multiple ascending dose trial designs and a pharmacodynamic interaction study with a combination of
oral aspirin and clopidogrel. Treatment with EP42675 resulted in dose-dependent increases in standard and specific coagulation tests and a decrease in thrombin generation. EP42675 showed predictable
pharmacokinetic (PK) and pharmacodynamic (PD) profiles, with a low intra- and inter-subject variability.
In animals, the PK/PD profiles of EP217609 and EP42675 are similar.
On the basis of EP42675 data, an optimized Phase I program has been defined for EP217609, with a view to quicker entry into Phase II in two target indications: extracorporeal circulation in cardiac surgery and
percutaneous coronary intervention in acute coronary syndromes.
The overall clinical development strategy for EP217609 and its antidote avidin has been endorsed by key national Health Authorities throughout Europe and by the Food and Drug Administration in the USA.
Phase I results with EP217609 and avidin are expected in early 2010.
* EP42675, a new dual-action anticoagulant: pharmacodynamic and pharmacokinetic profile, and
interactions with acetylsalicylic acid, clopidogrel, and unfractionated heparin. Pierre Gueret, Chantal
Krezel, Paul van Giersbergen, Eliane Fuseau, Thierry Lamy and Eric Neuhart.