ZymoGenetics bleeding trial meets primary, secondary endpoints

By Elaine Rigoli

Tampa, Fla., Sept. 18 - ZymoGenetics, Inc. said its pivotal phase 3 trial of recombinant human Thrombin (rhThrombin) as an aid to controlling bleeding during surgery met both its primary and secondary endpoints.

The trial compared rhThrombin to bovine thrombin, and data suggested that rhThrombin demonstrated comparable efficacy and a superior immunogenicity profile as compared to bovine thrombin.

The Seattle pharmaceutical company said the primary endpoint of the study was a comparison of the efficacy of rhThrombin versus bovine thrombin, as measured by the overall percentage of patients achieving hemostasis within 10 minutes.

The study showed that rhThrombin achieved hemostasis within 10 minutes 95.4% of the time and bovine thrombin achieving hemostasis within 10 minutes 95.1% of the time. Among the four types of surgery evaluated, the incidence of hemostasis within 10 minutes was similar between treatment groups.

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