Leo Pharma starts mid-stage anticoagulant trial

Leo Pharma is GTC Biotherapeutics’s partner for ATryn in Europe, Canada and the Middle East. The drug is GTC Biotherapeutics’s recombinant form of human antithrombin, which has both anticoagulant and anti-inflammatory properties. Full enrollment of about 200 patients into the phase II study is planned to take approximately 12 months, with results expected to be available in the second half of 2008.

A number of preclinical animal sepsis studies, as well as a human endotoxemia study, suggest that ATryn may have potential in the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis if provided without heparin, a critical care anticoagulant. A number of countries in Europe and Japan include the treatment of DIC associated with severe sepsis in the approved uses of plasma-derived antithrombin products.

The objective of the phase II study is to establish safety and to determine the optimum dose to be used in a subsequent phase III safety and efficacy study. GTC plans to use the phase II results as the basis of a discussion with the FDA on further clinical development of ATryn for the DIC indication in the US. GTC retains full commercial rights in the US, Japan, and the rest of the world outside the Leo territories.