Northfield Laboratories Briefs Senate Finance Committee Staff Members on PolyHeme Pivotal Phase III Trial
March 22 2006 - 6:44PM
Business Wire
Northfield Laboratories Inc. (NASDAQ: NFLD) announced today that
Steven A. Gould, M.D., Chairman and Chief Executive Officer,
briefed Senate Finance Committee staff members this afternoon about
the Company's clinical experience with its human hemoglobin-based
oxygen carrying red cell substitute, PolyHeme. In particular, Dr.
Gould reviewed the current Pivotal Phase III trial, which is being
conducted at Level I trauma centers across the United States. He
was accompanied by Ernest E. "Gene" Moore, M.D., Chief of Surgery
and Trauma Services, Denver Health Medical Center, lead
investigator for the study. Dr. Moore discussed the need for a red
cell substitute, his extensive clinical experience with PolyHeme,
and his research into the immunomodulatory effects of blood in the
early care of the trauma patient. About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying resuscitative fluid, PolyHeme(R), for the treatment
of urgent, large volume blood loss in trauma and resultant surgical
settings. PolyHeme(R) is a solution of chemically modified human
hemoglobin that requires no cross matching and is therefore
compatible with all blood types. It has a shelf life in excess of
12 months. Enrollment is currently underway in a pivotal Phase III
trial of PolyHeme(R) beginning in the pre-hospital setting. For
further information, visit www.northfieldlabs.com. This press
release may contain forward-looking statements concerning, among
other things, Northfield's future business plans and strategies and
clinical and regulatory developments affecting our PolyHeme(R) red
blood cell substitute product. These forward-looking statements are
identified by the use of such terms as "intends," "expects,"
"plans," "estimates," "anticipates," "should," "believes" and
similar terms. These forward-looking statements involve inherent
risks and uncertainties. Our actual results may therefore differ
materially from those predicted by the forward-looking statements
because of various factors and possible events, including our
ability to obtain FDA approval to market PolyHeme commercially, the
availability of capital to finance our clinical trials and ongoing
business operations, our ability to obtain adequate supplies of raw
materials and to manufacture PolyHeme in commercial quantities, our
ability to market PolyHeme successfully, the possibility that
competitors will develop products that will render PolyHeme
obsolete or non-competitive, our ability to protect our
intellectual property rights, the possibility that we may be
subject to product liability claims and other legal actions, our
dependency on a limited number of key personnel, the uncertainty of
third party reimbursement for our product and other risks and
uncertainties described from time to time in our periodic reports
filed with the Securities and Exchange Commission, including our
most recently filed quarterly report on Form 10-Q and annual report
on Form 10-K. These forward-looking statements speak only as of the
date of this press release. We do not undertake any obligation to
update or publicly release any revisions to forward-looking
statements to reflect events, circumstances or changes in
expectations after the time such statement is made. All subsequent
written and oral forward-looking statements attributable to
Northfield or any person acting on our behalf are qualified by this
cautionary statement.
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