>> ZymoGenetics Presents Aggregate Phase 2 Results for Recombinant Human Thrombin
Wednesday August 10, 1:03 pm ET
SEATTLE--(BUSINESS WIRE)--Aug. 10, 2005--ZymoGenetics (Nasdaq: ZGEN ) today presented the aggregate results of four Phase 2 clinical studies of recombinant human Thrombin (rhThrombin) at The International Society on Thrombosis and Haemostasis annual meeting in Sydney, Australia. The poster presentation is available at www.zymogenetics.com on the home page in the "What's New" section.
The combined Phase 2 study results showed that rhThrombin, a product candidate in development to control bleeding during surgery, appeared to be safe and well tolerated, with a favorable immunogenicity profile. A total of 130 patients undergoing spinal surgery, liver resection, peripheral artery bypass, or arteriovenous graft construction were evaluated.
ZymoGenetics is currently finalizing plans for the rhThrombin Phase 3 pivotal trial. The company expects to start treating patients in the Phase 3 trial later this year.
About rhThrombin
ZymoGenetics is developing rhThrombin for the control of bleeding associated with surgical procedures. Thrombin is used in over 700,000 surgeries per year in the United States. Currently, only thrombin derived from bovine blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins. In some cases, these antibodies lead to serious bleeding complications. Recombinant proteins, such as rhThrombin, can be manufactured to higher levels of purity and consistency than proteins purified from human or animal blood. Furthermore, the production of recombinant proteins is not dependent on the availability of blood from human or animal donors and can be scaled-up to meet market demands. For these reasons, ZymoGenetics believes that rhThrombin represents a potential preferred alternative to the bovine-derived product. <<
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