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ZymoGenetics completes enrollment for rhThrombin phase 3 trial
By E. Janene Geiss
Philadelphia, June 20 - ZymoGenetics, Inc. said Tuesday it has completed patient enrollment for a phase 3 pivotal clinical trial of recombinant human thrombin (rhThrombin) as an aid to controlling blood loss during surgery.
The trial data will be analyzed in the third quarter, and the company plans to disclose outcomes and present the study results at a scientific meeting before year-end, according to a company news release.
The pivotal trial was designed to compare rhThrombin to bovine thrombin, the currently marketed product, in four surgical settings and to evaluate the safety, efficacy and immunogenicity of the two products.
The study was designed to enroll 400 to 600 patients and, based on the recommendation of an independent data monitoring committee following a planned interim analysis, 400 evaluable subjects provided sufficient power for the planned efficacy comparison, officials said.
Assuming the endpoints in the study are met, ZymoGenetics said it plans to submit a Biologics Licensing Application for rhThrombin to the Food and Drug Administration in late 2006.
Thrombin is used in more than 700,000 surgeries each year in the United States. Currently, only thrombin derived from bovine blood is available in the United States 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 and in some cases these antibodies appear to be related to serious bleeding complications, officials said.
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, officials said.
ZymoGenetics is a Seattle biotechnology company.
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