Saturday, October 11, 2008
Interim Phase II Data Establishes Superiority Of Omrix Biopharma's Blood-clot Inducing Fibrin Pad Over Johnson & Johnson's SURGICEL
Wednesday, Omrix Biopharmaceuticals Inc. announced that according to the interim results of a phase II trial, its investigational Fibrin Pad, a blood-clot inducing material proved to be superior to SURGICEL, developed by Johnson and Johnson's Ethicon subsidiary. The Fibrin Pad is being evaluated as an adjunct to control mild to moderate soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.According to the interim analysis, 90 patients were randomized in the ratio of 2:1 to be treated with Fibrin Pad and SURGICEL, respectively. The primary efficacy end point measured the proportion of subjects achieving hemostatic success at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. Hemostasis is defined as no detectable bleeding at the target bleeding site.The company noted that since the superiority of Fibrin Pad has been established, randomization has been stopped and additional non-randomized patients are currently being enrolled and treated with Fibrin Pad. Enrollment in the Fibrin Pad arm will continue until a minimum of 100 subjects are enrolled, according to Omrix.The company expects to complete enrollment of the additional 40 patients required to be treated with the Fibrin Pad by the end of 2008 or early 2009.In addition, the company said that till date seven patients have been enrolled in the Israeli Phase II exploratory clinical trial, which is being conducted outside of a U.S. Investigational New Drug application study. Four have been treated with the Fibrin Pad, of which one patient experienced post-operative bleeding, which was considered a serious adverse event.Omrix also revealed that it has submitted a clinical trial application, or CTA, in the United Kingdom to conduct a pivotal study to evaluate the safety and efficacy of the Fibrin Pad in soft tissue severe bleeding when the product is applied adjunctively to the standard of care. Omrix expects the CTA, which is currently under review to be approved by the end of 2008 or early 2009. The company plans to commence the study shortly thereafter.