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news.Omrix Biopharmaceuticals has completed patient enrollment in a phase III pivotal trial of the company's human plasma derived thrombin product candidate designed to provide effective bleeding control without the risk of adverse reactions associated with the use of bovine-sourced hemostats.
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The pivotal trial will compare thrombin topical (human) to bovine thrombin in achieving intra-operative hemostasis (contol of bleeding) during cardiovascular, neurologic (spine) and general surgery procedures. A total of 304 patients were enrolled in the trial. The company's target indication for this study is general hemostasis.
“Today's announcement is aligned with our strategy to build the most comprehensive and competitively differentiated franchise in biosurgery, particularly in the area of hemostasis (bleeding control),” said Robert Taub, president and CEO of Omrix.
Mr Taub went on to say that the company is on track to submit a biologics licensing application seeking approval to market the drug before the end of the year.