Omrix Biopharmaceuticals Announces Patient Enrollment Will Resume In Fibrin Pad U.S. Phase II Clinical Trial In Mild to Moder...
24 Octobre 2008 - 9:27PM
Business Wire
Omrix Biopharmaceuticals, Inc. (�Omrix�) (NASDAQ: OMRI), a
fully-integrated biopharmaceutical company that develops and
markets biosurgical and immunotherapy products, announced today
that the Fibrin Pad U.S. Phase II clinical trial in mild to
moderate bleeding will resume patient enrollment and continue with
no modifications. On October 9, 2008, the Company announced that
the U.S. Phase II clinical trial had been suspended in order to
investigate an incident of post-operative bleeding. This event met
the stopping rules, as outlined in the clinical trial protocol. Per
the clinical trial protocol, upon the suspension of the study, a
Data Safety Monitoring Board, or DSMB, reviewed the data related to
the event. The DSMB has concluded their investigation and
authorized the trial to recommence. About the Fibrin Pad The Fibrin
Pad 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
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.
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