NFLD Northfield Laboratories Inc. (MM)

Northfield Laboratories Inc. (Nasdaq: NFLD) reported today that its ongoing pivotal Phase III trial is more than 85 percent complete. Northfield is developing a human hemoglobin-based oxygen-carrying red cell substitute, PolyHeme(R), for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings. Steven A. Gould, M.D., Chairman and Chief Executive Officer, made a presentation to investors this morning at the Cowen & Company Health Care Conference in Boston. Dr. Gould noted that the current study is based on two potential life-saving benefits. "The first life-saving opportunity is based on starting infusion of an oxygen-carrying fluid at the scene of injury, where blood is not available, and continuing during transport to the hospital," he said. "The second potential benefit is the opportunity to improve the outcome associated with the use of donated blood in the early hospital period in critically injured patients," he continued. Dr. Gould noted that there is a growing body of scientific evidence pointing to the adverse immunomodulatory effects of early blood transfusion in trauma patients, namely the incidence of multiple organ failure and resultant associated mortality. There are also data indicating that these same effects may not occur with PolyHeme. PolyHeme is therefore being evaluated as a potential alternative to blood in this setting. In addition Dr. Gould reported: -- More than 600 of the planned 720 patients have been accrued. -- The Company anticipates completion of enrollment in the second calendar quarter of 2006. -- The Independent Data Monitoring Committee (IDMC) responsible for overseeing patient safety in this study has on four occasions reviewed the mortality and serious adverse event data and has four times recommended that the study continue without modification. The last recommendation was made after 500 patients had been enrolled in the study. -- Northfield is currently reviewing bids for expanded manufacturing capacity. Interested investors may access the archived webcast of the presentation at www.northfieldlabs.com. It will be available for two weeks. 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.