Omrix Completes Enrollment Of Initial 90 Patients Needed To Conduct Interim Analysis In Fibrin Pad U.S. Phase II Clinical Trial

Main Category: Blood / Hematology
Also Included In: Medical Devices / Diagnostics
Article Date: 23 Sep 2008 - 8:00 PDT

email to a friend   printer friendly   view / write opinions

Omrix Biopharmaceuticals, Inc. ("Omrix") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The Company expects to release 90 patient interim efficacy analysis by the end of October 2008.

The Fibrin Pad is a breakthrough convergence product being developed by Omrix in collaboration with ETHICON, INC., a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to SURGICEL. The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized 2 to 1 so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with SURGICEL.

The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to SURGICEL. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.

The study protocol provides for the enrollment of up to 210 patients. In the event that the interim analysis from the first 90 patients does not show superiority, the study will continue with 2 to 1 randomized enrollment in increments of 30 patients. The Company would then assess superiority after each 30 patient increment. The Company anticipates that if additional enrollment is required, then the study will be extended by several months for each additional block of 30 patients needed to demonstrate superiority.

About the Fibrin Pad

The Fibrin Pad is being developed in collaboration with ETHICON, Inc., a Johnson & Johnson company, and builds on the Company's aprotinin-free fibrin sealant technology incorporated into EVICEL* Fibrin Sealant (Human). The Fibrin Pad is designed for the management and rapid control of mild, moderate and severe bleeding. This next generation, fully absorbable biosurgical product candidate combines medical device and proprietary biological components which form an instant clot when they come in contact with blood.

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.