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Endotis Pharma Presents Phase I Clinical Trials Results for EP42675, a First-in-Class Synthetic Parenteral Anticoagulant


12/4/2009 10:18:50 AM

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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.

About Endotis Pharma (www.endotis.com) Endotis Pharma is a biopharmaceutical company dedicated to the discovery and development of small-glyco drugs (heparin/heparan sulfate mimetics) in thrombosis, oncology and a range of other indications. The value of this platform has been demonstrated by Endotis' breakthrough thrombosis franchise of parenteral and oral drugs in clinical and preclinical development and a promising oncology pipeline. Endotis has 35 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

Juliette Vandenbroucque + 33 (0)1 41 22 07 32 juliette@alizerp.com

Investor contact: Endotis Pharma Charles Woler, Chairman and CEO charleswoler@endotis.com Stéphane Degove, Head of Finance stephanedegove@endotis.com +33 (0)1 48 46 84 87


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