OMRIX Biopharmaceuticals, Inc. a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today positive results from its Phase 3 pivotal clinical trial of human thrombin in achieving hemostasis in general surgery procedures. The non-inferiority clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of safety and efficacy. All primary endpoints were met.
"We are pleased with the results of our pivotal Phase 3 Thrombin trial and intend to file our BLA by November 15, 2006," said Robert Taub, President and Chief Executive Officer. "OMRIX is committed to advancing its biosurgery pipeline and commercializing a product portfolio of safe, effective and easy to use solutions for surgeons worldwide."
THROMBIN is an enzyme in the blood coagulation cascade. Blood coagulates by the transformation of soluble fibrinogen into insoluble fibrin. There are steps in the cascade to arrest bleeding from a damaged blood vessel and thrombin one of these enzymes. Many of these clotting factors are targets for drug therapy. This drug will replace bovine thrombin, since there have been problems with immune reactions (rejection).
The stock is down 14% to 17.51 at this hour. The stock is down even though all endpoints of the trial were met, yet the net effect of the drug was not as effective as planned.(NASDAQ:OMRI)
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