EVANSTON, Ill.--(BUSINESS WIRE)--July 31, 2006--Northfield
Laboratories Inc. (NASDAQ: NFLD) announced today that patient
enrollment is complete in its pivotal Phase III trauma study with
PolyHeme(R), the Company's human hemoglobin-based oxygen-carrying red
blood cell substitute.
"We are pleased to have completed enrollment in this complex Phase
III study -- another key milestone in our progress toward bringing
PolyHeme(R) to market," said Steven A. Gould, M.D., Chairman and Chief
Executive Officer. "We are eager to begin the data analysis, and look
forward to reporting top-line results from the study in the fall."
The PolyHeme(R) trial is the first study in the U.S. designed to
evaluate the safety and efficacy of an oxygen-carrying red blood cell
substitute beginning at the scene of injury and continuing during
transport and in the early hospital period. The study had a planned
enrollment of 720 and was conducted at major Level I trauma centers
throughout the United States. The primary endpoint is survival at 30
days.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying red blood cell substitute for the treatment of
life-threatening blood loss, when an oxygen-carrying fluid is required
and red blood cells are not available. 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. 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 outcome of certain governmental inquiries and purported
class action lawsuit as described in our most recently filed quarterly
report on Form 10-Q, 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.
CONTACT: Northfield Laboratories Inc.
Vice President, Corporate Communications
Sophia H. Twaddell, 847-864-3500
stwaddell@northfieldlabs.com
or
Fleishman-Hillard
Tom Laughran, 312-751-3519
laughrant@fleishman.com
SOURCE: Northfield Laboratories Inc.