EVANSTON, Ill.--(BUSINESS WIRE)--March 1, 2006--The management of Northfield Laboratories Inc. issued the following statement in response to a Commentary (and subsequent media coverage of the Commentary) published in the March-April issue of the journal IRB: Ethics & Human Research entitled, "Trials and Errors: Barriers to Oversight of Research Conducted under the Emergency Research Consent Waiver."
The Commentary and coverage in question make errors of fact in the discussion of the ongoing Pivotal Phase III trauma trial.
1) It is incorrect to refer to PolyHeme as "fake blood." PolyHeme is a human hemoglobin-based oxygen-carrying red cell substitute.
2) The study is being conducted under a federal regulation (21CFR 50.24), which allows a waiver of informed consent in emergency research if specific criteria are met. The protocol meets these criteria.
3) We have adhered scrupulously to the rule and its published Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.
4) 32 Institutional Review Boards at Level I trauma centers throughout the country have reviewed and approved the protocol. Level I trauma centers--as designated by the American College of Surgeons--are located in both large metropolitan areas and smaller cities--where the majority of trauma victims are cared for. It is in these Centers where the need and the potential for PolyHeme to save lives are greatest.
5) 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.
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.
Northfield Laboratories Inc., Evanston
Sophia H. Twaddell, 847-864-3500
Northfield Laboratories Inc.