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news.ZymoGenetics has presented encouraging results from a clinical trial with Recothrom Thrombin, a topical administered by spray device to burn wound excision sites.
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The study evaluated the safety and immunogenicity of Recothrom for patients undergoing skin grafting for burns. Topical application of Recothrom using a pump spray device was well tolerated and demonstrated a similar safety profile and rate of antibody formation to that observed in the rThrombin Phase III clinical trial.
The multiple site, single-arm, open-label clinical trial treated 72 subjects receiving partial- or full-thickness autologous sheet or mesh graft following burn injury. There were no deaths or study drug discontinuations.
Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “Results from the trial show that Recothrom was well-tolerated when sprayed onto excised burn wounds prior to skin graft placement, with a very low rate of antibody development consistent with data generated in our earlier clinical trials.”