Seattle-based ZymoGenetics announced that a pivotal Phase III study of Thrombin showed that it was as effective in stopping surgical bleeding as the standard therapy while also proving safer. A total of 1.5 percent of the patients taking Thrombin among the 411 volunteers in the trial developed antibodies against Thrombin compared to 22 percent of volunteers taking a cow-blood based therapy. An antibody reaction can trigger bleeding.
Thrombin is a protein made through gene-splicing that mimics a human clotting protein. ZymoGenetics CEO Bruce Carter said that the company is on schedule to ask for FDA approval later this year and bring a product to market in 2007. Recent surveys have indicated that doctors prefer engineered proteins over proteins derived from either humans or animals. If so, ZymoGenetics would be well positioned to grab a commanding share of the market. The company's shares were buoyed by the news in overnight trading.
- read this article on the trial from the Seattle Times