ZymoGenetics, Inc. has completed patient enrolment for a phase 3 pivotal clinical trial of recombinant human thrombin (rhThrombin) as an aid to controlling blood loss during surgery.
The phase 3 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.
The pivotal phase 3 clinical 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 enrol 400 - 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. Assuming the endpoints in the study are met, ZymoGenetics plans to submit a Biologics Licensing Application (BLA) for rhThrombin to the FDA in late 2006.
"Through the motivation of our external clinical investigators and hard work of our internal staff, we were able to complete patient enrolment on schedule," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "This allows us to continue to pursue our plan for submission of a BLA to the FDA by year end and, we hope, to provide an effective and safe alternative for the control of surgical bleeding."
ZymoGenetics is developing rhThrombin for the control of bleeding associated with surgical procedures. 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 US 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. 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.