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www.fdanews.com/articles/87732-zymogenetics-completes-enrollment-for-rhthrombin-trial

ZYMOGENETICS COMPLETES ENROLLMENT FOR RHTHROMBIN TRIAL

June 20, 2006

ZymoGenetics has completed patient enrollment for a Phase III pivotal clinical trial of recombinant human thrombin (rhThrombin) as an aid to controlling blood loss during surgery.

The pivotal clinical trial was designed to compare rhThrombin to bovine thrombin (the currently marketed product) in four surgical settings and to evaluate the safety, efficacy and immunogenicity of the two products. The study was designed to enroll 400 to 600 patients and, based on the recommendation of an independent data monitoring committee following a planned interim analysis, 400 evaluable subjects provided sufficient power for the planned efficacy comparison.