GTC Enrolling Patients in Atryn Trial

GTC Biotherapeutics announced that its partner for ATryn in Europe, Canada and the Middle East, Leo Pharma, has enrolled the first patient in a Phase II study of the recombinant antithrombin product for the treatment of disseminated intravascular coagulation (DIC) in association with severe sepsis.

Full enrollment of approximately 200 patients into the Phase II study is planned to take roughly 12 months with results expected to be available in the second half of 2008, GTC said.

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, the company said.

GTC said it 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 in the U.S. The company added that it retains full commercial rights in the US, Japan and the rest of the world outside the Leo territories.