Company presents ATryn safety and efficacy data.

2004 APR 1 - (NewsRx.com & NewsRx.net) -- GTC Biotherapeutics, Inc., (GTC, GTCB) presented safety and efficacy data from its recently completed multinational trial of ATryn (recombinant human antithrombin) in the treatment of patients with hereditary antithrombin deficiency (HD) undergoing high-risk procedures such as surgery and childbirth.

Presentations were made on GTC's behalf by Dr. Mario von Depka of the Medizinische Hochschule Hannover, an investigator in the trial, and Dr. Johan Frieling of Genzyme Europe, B.V., the trial's medical monitor. In the trial, treatment with ATryn was found to be efficacious in preventing the development of symptomatic deep vein thromboses (DVT) and other thromboembolic complications which may occur in patients with confirmed hereditary antithrombin deficiency who are undergoing high risk surgical procedures or labor and delivery.

"We believe that ATryn will be found to be an effective treatment for the prevention of peri- and postsurgical thromboembolic complications in patients with hereditary antithrombin deficiency," stated Johan Frieling, MD, PhD, associate director of clinical research at Genzyme Europe, B.V., in the Netherlands. Genzyme Europe, B.V., collaborates with GTC on the clinical studies and regulatory submission for ATryn.

The clinical study was conducted in accordance with scientific advice received from the European Medicines Evaluation Agency (EMEA) and evaluated the safety and efficacy of ATryn in HD patients in clinical high risk situations. Based on this and prior studies, GTC recently submitted a market authorization application for ATryn to the EMEA which has been accepted for review. The safety and efficacy study enrolled 14 patients from Europe and the United States.

The high-risk situations treated included five surgeries and nine childbirths. The surgeries included four hip replacement procedures. The childbirths included natural, induced, and ...