GTC Completes Enrollment for ATryn Pivotal Study
Posted on: Tuesday, 26 February 2008, 09:01 CST
GTC Biotherapeutics has said that ATryn has completed enrollment in the pivotal study for the treatment of patients with hereditary antithrombin deficiency or HD, undergoing high-risk surgical or childbirth procedures.
A minimum of 31 evaluable HD patients were required for the ATryn treatment trial. Results for 14 of these patients were already obtained from the previous study that supported ATryn's approval in the EU. Seventeen evaluable patients have been treated to complete the pivotal study. There were no clinically relevant DVTs or other thromboembolisms during the evaluation period in any of the patients treated in the pivotal study.
Geoffrey Cox, chairman and CEO of GTC, said: "We look forward to completing our rolling biologics license application as planned around mid-2008, when we submit the full clinical data package. ATryn is unique in being the only recombinant form of human antithrombin to be developed for therapeutic use, as recognized in its orphan drug status for the HD indication."
Source: Datamonitor
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