Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Omrix Biopharmaceuticals has said that a phase III trial of its human thrombin product to control bleeding has met all its goals.
Subscribe to our email newsletter
The clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of safety and efficacy in surgical procedures.
The phase III clinical trial was conducted in subjects undergoing elective surgical procedures, including cardiovascular surgery, spine procedures, and general surgery or post-traumatic procedures. The study was designed to support broad product labeling for the use of thrombin as an aid to control bleeding during surgery.
The study met its primary endpoint, with both human and bovine thrombin achieving hemostasis within 10 minutes, 97.4% of the time.
“We are pleased with the results of our pivotal phase III thrombin trial and intend to file our BLA by November 15, 2006,” said Robert Taub, president and CEO of Omrix.
Omrix develops and markets biosurgical and antibody-based products, utilizing its proprietary protein purification technology.