ZYMOGENETICS' RECOMBINANT HUMAN THROMBIN PHASE II CLINICAL TRIAL RESULTS

ZymoGenetics has announced highlights from a presentation given by clinical investigator Jeffrey Lawson, M.D. of Duke University Medical Center at the spring meeting of the Peripheral Vascular Surgery Society in Chicago.

The presentation, titled "Phase II Evaluation of Topical Recombinant Human Thrombin for Hemostasis in Subjects Undergoing Vascular Surgery," discussed findings of two clinical trials conducted with patients undergoing either arteriovenous grafting surgery for hemodialysis access or peripheral artery bypass surgery.

The primary objective of these randomized, double-blinded clinical trials was to assess the safety of rhThrombin as a surgical hemostat. Secondary objectives included determinations of immunogenicity and point estimates of time to hemostasis.

Only one of thirty-seven exposed patients produced detectable antibodies to rhThrombin. This compares favorably to published results of studies involving bovine thrombin, in which more than 40 percent of treated patients generated antibodies to the bovine product (Ortel, 2001).

Ninety percent of rhThrombin-treated bleeding sites achieved hemostasis by 10 minutes, compared to only 74 percent of those treated with placebo. The average time to hemostasis in rhThrombin-treated patients was 27 percent lower than in patients treated with placebo.