Omrix Biopharmaceuticals Initiates Phase II Clinical Trial In Israel For Fibrin Pad Product Candidate

Main Category: Medical Devices
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Jul 2008 - 1:00 PDT

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Omrix Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI) announced 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® 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 http://www.omrix.com.

Safe Harbor Statement

This news release contains forward-looking statements. Forward-looking statements provide the Company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The Company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the Company's filings with the Securities and Exchange Commission (SEC), including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form 10-K as filed with the SEC on March 17, 2008, and the Company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this news release.