ZymoGenetics (ZGEN)

[surf1944]

6:10AM Zymogenetics announces new publication supports safety profile of RECOTHROM thrombin, topical in numerous surgical settings (ZGEN) 5.65 : Co announces the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins. "These pooled safety data are significant, as they provide a robust clinical trial data set for a topical hemostat, The adverse events observed were consistent with those expected in the surgical populations studied, and immune response to RECOTHROM was consistently low, with no development of antibodies that neutralized native human thrombin."