ZymoGenetics reports positive results from phase 3 trial of rhThrombin

New York, Sept. 5 - ZymoGenetics, Inc. said a phase 3 clinical study of recombinant human Thrombin (rhThrombin) met its primary endpoint.

Treatment of 411 patients with rhThrombin and bovine thrombin resulted in comparable incidence of hemostasis at 10 minutes in the four surgical settings tested, spinal surgery, liver resection, peripheral artery bypass and arteriovenous graft construction.

The rate of antibody formation was 1.5% in response to treatment with rhThrombin, versus 22% for those treated with the bovine thrombin product, the Seattle-based drugs company said.

Of patients in the bovine thrombin group who had pre-existing antibodies to the bovine thrombin product, eight of 10 showed a 10-fold or greater increase in antibody levels over baseline measurements.

The rates of adverse events and serious adverse events between the two treatment arms of the study were comparable.

"In this study, recombinant human thrombin showed a superior immunogenicity profile to bovine thrombin and was highly effective in treating acute surgical bleeding," said Bruce L.A. Carter, president and chief executive officer of ZymoGenetics, in a news release. "We remain on schedule for the filing of a Biologics License Application with the FDA before the end of this year."

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