|
Omrix Biopharmaceuticals announced today that it has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate
NEW YORK, NY, USA | July 2, 2008 | Omrix Biopharmaceuticals, Inc. (Omrix or the Company) (NASDAQ: OMRI) announced today that it has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate. This is the first clinical trial that will evaluate the Fibrin Pad's performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ. The Phase II clinical trial in Israel is being conducted simultaneously with the Phase II clinical trial in the U.S., which commenced on March 27, 2008 and is under an Investigational New Drug (IND) application that was filed with the Food and Drug Administration (FDA) in November 2007.
The Fibrin Pad is a breakthrough convergence product candidate comprised of biological components in a biodegradable device. In collaboration with ETHICON, INC., a Johnson & Johnson company, the Fibrin Pad is being developed for the management and rapid control of mild, moderate and severe bleeding.
About the Phase II Clinical Trials in the US and Israel
The US trial is a randomized, controlled clinical study that will evaluate the superiority of the Fibrin Pad when compared to SURGICEL(R) Absorbable Hemostat. In this study, the Fibrin Pad is applied to soft tissue as an adjunct to hemostasis in mild to moderate bleeding. The Israeli trial is a randomized, controlled clinical study that will evaluate the safety and efficacy of the Fibrin Pad when compared to the standard of care, defined as suture, cautery, ligature or passive hemostats. In this study, the Fibrin Pad is applied directly onto the solid organ in severe bleeding. The trials also differ in the number of patients to be enrolled (up to 210 patients in the US trial and up to 30 patients in the Israeli trial).
Phase II Clinical Trial Design in Israel
This study will enroll up to 30 patients undergoing partial nephrectomy, who will be randomized into two treatment arms: (1) 10 patients will be treated in accordance with the standard of care; and (2) 20 patients will be treated with the Fibrin Pad applied directly onto the solid organ. The endpoints will measure both safety and efficacy. The primary efficacy endpoint will measure time to hemostasis at 10 minutes and if any re-bleeding occurs during a subsequent 6 minute observation period. The clinical trial has a 1 month follow-up period.
About Omrix Biopharmaceuticals, Inc.
Omrix is a fully integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential biodefense applications. For more information, please visit www.omrix.com.
SOURCE: Omrix Biopharmaceuticals, Inc. |
