Northfield Laboratories Statement Regarding Its Pivotal Phase III Trial

-- 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 studywith the utmost concern for patient safety. We believe the protocol isappropriate to evaluate a new therapy with potential life-savingcapability addressing a critical, unmet clinical need. The study meetsthe criteria set forth in 21 CFR 50.24; we have adhered scrupulouslyto the rule.

This federal regulation was issued in 1996. It allows a waiver ofinformed consent when patients are in a life-threatening situation,when obtaining individual informed consent is impossible, and whencurrent therapy is unproven or unsatisfactory. The most criticalstipulation is that there is the potential for direct benefit to thepatients 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 March2003. Thirty-two Institutional Review Boards at Level I trauma centershave reviewed the study protocol and Investigator's Brochure thatsummarize all prior studies, conducted community consultation andpublic disclosure activities, and approved patient enrollment. A fewsites recently suspended patient enrollment temporarily whilereviewing their activities. Three are once again enrolling.

The study is based on two potential life-saving benefits. Thefirst is starting infusion of an oxygen-carrying fluid at the scene ofinjury and continuing during transport to the hospital. Because bloodis not routinely carried in ambulances, PolyHeme represents apotential improvement over the current standard of care.

The second opportunity is the potential to improve the outcomeassociated with the use of donated blood in the early hospital periodin critically injured patients. Although blood is the current standardof care, there is a growing body of scientific evidence pointing tothe adverse immunomodulatory effects of early blood transfusion intrauma patients, specifically the incidence of multiple organ failureand the resultant associated mortality. There are also published dataindicating that these same effects may not occur with PolyHeme. Thuswhile it is true that blood is available in the hospital, it may notbe the optimal treatment for the early care of trauma, and PolyHeme isbeing evaluated as a potential better alternative.

This is the scientific and ethical basis for continuing treatmentwith PolyHeme for up to 12 hours following injury or a dose of sixunits as approved by the 32 participating IRBs.

Special safeguards are in place to protect patients enrolled inthe study. An Independent Data Monitoring Committee was established toreview the safety data from the study at four pre-specified numbers ofpatients enrolled. The IDMC recently reiterated its recommendation tocomplete the trial based on four separate reviews of mortality andadverse event data from the first 500 patients enrolled. The IDMCissued the following statement:"As has been reported to Northfield Laboratories regarding thefinal assessment of the interim data, including 500 randomizedpatients, there were no statistically significant trends or safetyissues identified to warrant modification or other changes in thecurrent protocol and patient recruitment. The IDMC conclusion is thatcompletion of the trial is appropriate with completion of datasets andfinal analysis indicated."

Although the foregoing information has been widely disseminated,what may be less well understood is the fact that defined proceduresare in place for notification of enrollment at the earliest feasibleopportunity.

As specified in the protocol, once the patient arrives at thehospital, the investigator and study staff, along with hospitalpersonnel, make rigorous attempts to contact a legally authorizedrepresentative or family member if the patient remains incapacitated.

Ideally, during this period, the patient will stabilize and havethe ability to review the informed consent document and studyprocedures and make a decision regarding further participation ordiscontinuation in the study. If a patient is enrolled in the studyunder provisions for exception from informed consent requirements,contact with a legally authorized representative or family member isto 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 foran exception from the requirement for informed consent. As is the casewith all studies conducted under the waiver regulation, specialsafeguards are in place to protect patients enrolled in this study.

About Northfield Laboratories

Northfield Laboratories Inc. is a leader in developing anoxygen-carrying resuscitative fluid, PolyHeme(R), for the treatment ofurgent, large volume blood loss in trauma and resultant surgicalsettings. PolyHeme(R) is a solution of chemically modified humanhemoglobin that requires no cross matching and is therefore compatiblewith all blood types. It has a shelf life in excess of 12 months.Enrollment is currently underway in a pivotal Phase III trial ofPolyHeme(R) beginning in the pre-hospital setting. For furtherinformation, visit www.northfieldlabs.com.

This press release may contain forward-looking statementsconcerning, among other things, Northfield's future business plans andstrategies and clinical and regulatory developments affecting ourPolyHeme(R) red blood cell substitute product. These forward-lookingstatements are identified by the use of such terms as "intends,""expects," "plans," "estimates," "anticipates," "should," "believes"and similar terms. These forward-looking statements involve inherentrisks and uncertainties. Our actual results may therefore differmaterially from those predicted by the forward-looking statementsbecause of various factors and possible events, including our abilityto obtain FDA approval to market PolyHeme commercially, theavailability of capital to finance our clinical trials and ongoingbusiness operations, our ability to obtain adequate supplies of rawmaterials and to manufacture PolyHeme in commercial quantities, ourability to market PolyHeme successfully, the possibility thatcompetitors will develop products that will render PolyHeme obsoleteor non-competitive, our ability to protect our intellectual propertyrights, the possibility that we may be subject to product liabilityclaims and other legal actions, our dependency on a limited number ofkey personnel, the uncertainty of third party reimbursement for ourproduct and other risks and uncertainties described from time to timein our periodic reports filed with the Securities and ExchangeCommission, including our most recently filed quarterly report on Form10-Q and annual report on Form 10-K. These forward-looking statementsspeak only as of the date of this press release. We do not undertakeany obligation to update or publicly release any revisions toforward-looking statements to reflect events, circumstances or changesin expectations after the time such statement is made. All subsequentwritten and oral forward-looking statements attributable to Northfieldor any person acting on our behalf are qualified by this cautionarystatement.