Home
Buy & Subscribe
Special Features
Products & Services
Online Store
Products by category
Products by publisher
Product lines
News Channels
Biotechnology
Therapeutic Areas
Business
RSS Feeds
Free RSS News
Get the latest news direct
to your desktop
feed image

Search in our News Channels

 

Search in our Online Store

OMRIX Biopharmaceuticals Commences Phase 1 Clinical Trial for Fibrin Patch Print E-mail
08 Dec 2006
Today that it has commenced a Phase 1 clinical trial for its Fibrin Patch product for the management and rapid control of bleeding including severe bleeding in surgery.

NEW YORK, NY, USA | Dec 07, 2006 |
OMRIX Biopharmaceuticals, Inc. (“OMRIX” or the “Company”) (NASDAQ: 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 for its Fibrin 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 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 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) 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 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 and human thrombin components. Upon contact with a bleeding surface, the matrix hydrates and the fibrinogen-thrombin reaction initiates the key step in the coagulation cascade. 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 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.

SOURCE: OMRIX Biopharmaceuticals, Inc




Digg!Reddit!Del.icio.us!Google!Live!Facebook!Slashdot!Netscape!Technorati!StumbleUpon!Spurl!Wists!Simpy!Newsvine!Blinklist!Furl!Fark!Blogmarks!Yahoo!Smarking!Netvouz!Shadows!RawSugar!Ma.gnolia!PlugIM!Squidoo!BlogMemes!FeedMeLinks!BlinkBits!Tailrank!linkaGoGo!Free social bookmarking plugins and extensions for Joomla! websites! title=
 

PipelineReview.com is powered by La Merie Business Intelligence La Merie Business Intelligence

For immediate assistance, please call us during business hours: Mon-Fri 09:00am - 18:30pm; GMT+01

La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com
All contents © by La Merie S. L

Competitor Analysis Series

Enzyme Replacement Therapies

Order Now

Brief Report Series

CD40 and CD40L (CD154) Agonists & Antagonists

Order Now

Subscribe La Merie Biologics