Northfield Laboratories Statement Regarding Its Pivotal Phase III Trial

Northfield Laboratories (Nasdaq: NFLD) released the
following statement today in response to news reports that Senator
Charles Grassley (R-Iowa) has raised specific questions about the
Northfield trauma trial research protocol, in particular, two aspects
of the current PolyHeme study:

   --  Whether or not the protocol meets the requirements for 21 CFR
        50.24 waiver of informed consent; and

   --  Whether or not it is ethical to continue infusion of PolyHeme
        in the hospital setting where blood is available

   Northfield is committed to conducting its pivotal Phase III study
with the utmost concern for patient safety. We believe the protocol is
appropriate to evaluate a new therapy with potential life-saving
capability addressing a critical, unmet clinical need. The study meets
the criteria set forth in 21 CFR 50.24; we have adhered scrupulously
to the rule.
   This federal regulation was issued in 1996. It allows a waiver of
informed consent when patients are in a life-threatening situation,
when obtaining individual informed consent is impossible, and when
current therapy is unproven or unsatisfactory. The most critical
stipulation is that there is the potential for direct benefit to the
patients enrolled, which FDA has interpreted to mean survival benefit.
Our study meets these criteria.
   FDA authorized the study to proceed under 21 CFR 50.24 in March
2003. Thirty-two Institutional Review Boards at Level I trauma centers
have reviewed the study protocol and Investigator's Brochure that
summarize all prior studies, conducted community consultation and
public disclosure activities, and approved patient enrollment. A few
sites recently suspended patient enrollment temporarily while
reviewing their activities. Three are once again enrolling.
   The study is based on two potential life-saving benefits. The
first is starting infusion of an oxygen-carrying fluid at the scene of
injury and continuing during transport to the hospital. Because blood
is not routinely carried in ambulances, PolyHeme represents a
potential improvement over the current standard of care.
   The second opportunity is the potential to improve the outcome
associated with the use of donated blood in the early hospital period
in critically injured patients. Although blood is the current standard
of care, there is a growing body of scientific evidence pointing to
the adverse immunomodulatory effects of early blood transfusion in
trauma patients, specifically the incidence of multiple organ failure
and the resultant associated mortality. There are also published data
indicating that these same effects may not occur with PolyHeme. Thus
while it is true that blood is available in the hospital, it may not
be the optimal treatment for the early care of trauma, and PolyHeme is
being evaluated as a potential better alternative.
   This is the scientific and ethical basis for continuing treatment
with PolyHeme for up to 12 hours following injury or a dose of six
units as approved by the 32 participating IRBs.
   Special safeguards are in place to protect patients enrolled in
the study. An Independent Data Monitoring Committee was established to
review the safety data from the study at four pre-specified numbers of
patients enrolled. The IDMC recently reiterated its recommendation to
complete the trial based on four separate reviews of mortality and
adverse event data from the first 500 patients enrolled. The IDMC
issued the following statement:

"As has been reported to Northfield Laboratories regarding the
final assessment of the interim data, including 500 randomized
patients, there were no statistically significant trends or safety
issues identified to warrant modification or other changes in the
current protocol and patient recruitment. The IDMC conclusion is that
completion of the trial is appropriate with completion of datasets and
final analysis indicated."

   Although the foregoing information has been widely disseminated,
what may be less well understood is the fact that defined procedures
are in place for notification of enrollment at the earliest feasible
opportunity.
   As specified in the protocol, once the patient arrives at the
hospital, the investigator and study staff, along with hospital
personnel, make rigorous attempts to contact a legally authorized
representative or family member if the patient remains incapacitated.
   Ideally, during this period, the patient will stabilize and have
the ability to review the informed consent document and study
procedures and make a decision regarding further participation or
discontinuation in the study. If a patient is enrolled in the study
under provisions for exception from informed consent requirements,
contact with a legally authorized representative or family member is
to be attempted at least:

   --  Every 30 minutes for the first two hours; then

   --  Every one hour through 12 hours postinjury, then

   --  Twice daily through Day 7, then

   --  Once weekly through Day 30, if not previously accomplished.

   Northfield is confident that its protocol meets the criteria for
an exception from the requirement for informed consent. As is the case
with all studies conducted under the waiver regulation, special
safeguards are in place to protect patients enrolled in this study.

   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.