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OMRIX Biopharmaceuticals Commences Phase 1 Clinical Trial for Fibrin Patch.


NEW YORK New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 -- OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: OMRI), a commercial-stage biopharmaceutical company that develops and markets biosurgical and antibody-based products, announced today that it has commenced a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study.  for its Fibrin fibrin: see blood clotting.  Patch product for the management and rapid control of bleeding including severe bleeding in surgery.

"We are delighted to advance our Fibrin Patch product into the clinical stage of development," stated Robert Taub, OMRIX' President and Chief Executive Officer. "We believe this product will address severe bleeding, a current unmet medical need, and provide surgeons with an additional tool to effectively achieve hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis)
1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means.

2.
 in surgery."

Pre-clinical study results indicate that the Fibrin Patch is capable of managing and rapidly controlling a broad spectrum of bleeding, including severe bleeding, and can be utilized on active bleeding sites. These studies include several animal models of severe hemorrhagic Hemorrhagic
A condition resulting in massive, difficult-to-control bleeding.

Mentioned in: Hantavirus Infections


hemorrhagic

pertaining to or characterized by hemorrhage.
 trauma. Traumatic injury animal models represent "worst-case" bleeding scenarios and were used to demonstrate the utility of this product in circumstances beyond those anticipated in a clinical setting.

Based on pre-clinical data, a Phase 1 clinical trial was designed and subsequently approved by the Israeli Ministry of Health (MOH See modem on hold. ) to evaluate the safety of the Fibrin Patch in humans. The Phase 1 trial is a prospective, open-label study in which the Fibrin Patch will be used as an adjunct to hemostasis. Ten eligible patients undergoing elective partial nephrectomy Nephrectomy Definition

Nephrectomy is the surgical procedure of removing a kidney or section of a kidney.
Purpose

Nephrectomy, or kidney removal, is performed on patients with cancer of the kidney (renal cell carcinoma); a disease in
 will be enrolled in this study. The surgery will be performed according to the standard of care. Safety parameters will be followed in this study including but not limited to adverse events.

About the Fibrin Patch

The Fibrin Patch is a sterile bio-absorbable combination product composed of a flexible matrix, coated with human fibrinogen Fibrinogen

The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion
 and human thrombin thrombin: see blood clotting.  components. Upon contact with a bleeding surface, the matrix hydrates and the fibrinogen-thrombin reaction initiates the key step in the coagulation cascade Coagulation cascade
The sequence of biochemical activities, involving clotting factors, that stop bleeding by forming a clot.

Mentioned in: Fibrin Split Products, Partial Thromboplastin Time
. The fibrin clot, as well as the matrix, is subsequently absorbed during wound healing. The Fibrin Patch is being developed for the management and rapid control of bleeding, including severe bleeding, and is intended for use on active bleeding sites. The Fibrin Patch is one of the biosurgical products OMRIX is developing in collaboration with Ethicon, a Johnson & Johnson company, and is intended to be marketed by Ethicon.

About OMRIX Biopharmaceuticals, Inc.

OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and antibody-based products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX' novel and easy-to-use Fibrin Patch, a biological-device convergence product candidate, addresses unmet medical needs. For more information, please visit: www.omrix.com.

Safe Harbor Statement

This press 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 SEC, including sections entitled "Risk Factors" and "Management's Discussion and Analysis Management's discussion and analysis (MD&A)

A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial
 of Financial Condition and Results of Operations" in the company's registration statement as filed with the Securities and Exchange Commission on December 4, 2006 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 press release.

OMRI-G
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 7, 2006
Words:640
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