Northfield Laboratories Inc. Announces Result of Fourth Interim Analysis of PolyHeme Pivotal Phase III Study

- Study Continues Without Modification - 


EVANSTON, Ill., Nov. 15  /PRNewswire-FirstCall/ -- Northfield Laboratories Inc. (NASDAQ:NFLD) announced today that the Independent Data Monitoring Committee (IDMC) has recommended that the Company's pivotal Phase III trial with PolyHeme(R) continue without modification following the fourth planned interim analysis of the study data.  The IDMC reviewed blinded data on mortality in the first 500 patients enrolled in the study.  This is the first time a hemoglobin-based oxygen-carrying resuscitative fluid has successfully passed this patient evaluation milestone in the high-risk trauma population.

"This is a key milestone for Northfield and our development of PolyHeme," said Steven A. Gould, M.D., Chairman and Chief Executive Officer.   "We are extremely pleased with this fourth recommendation.  Northfield has made sustained progress in the trial this year and we are looking forward to completing enrollment early next year."

Northfield's pivotal Phase III study is designed to evaluate the safety and efficacy of PolyHeme(R), the Company's human hemoglobin-based oxygen- carrying resuscitative fluid, when administered to patients in hemorrhagic shock following traumatic injury.  It is the first study in the United States in which treatment with an oxygen-carrying resuscitative fluid begins at the scene of injury.  Patients are currently being enrolled at 24 Level I trauma centers throughout the United States, with a planned total enrollment of 720 patients. The primary endpoint is survival at 30 days.

The IDMC is a group of experts, not associated with Northfield, responsible for periodically evaluating the safety data from the study and making recommendations relating to the continuation or modification of the study to minimize any identified risks to patients.  The four "interim looks" were defined in the study protocol and were scheduled to occur after the first 60, 120, 250 and 500 patients were enrolled and followed for a 30-day period. As with each preceding interim analysis, the IDMC will continue to receive and assess all cumulative safety data on the patients enrolled for this review, focusing on mortality and serious adverse events.  Northfield receives a recommendation after each review, but does not have access to the actual data or the IDMC deliberations.  The Company will remain shielded from the data until the study is complete.

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 of over 12 months.  Enrollment is currently underway in a pivotal Phase III study of PolyHeme(R) beginning in the pre-hospital setting.  For further information about Northfield Laboratories, visit http://www.northfieldlabs.com/

This press release contains forward-looking statements concerning, among other things, Northfield's future business plans and strategies and clinical and regulatory developments affecting our PolyHeme blood 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 Fourth, Final 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.

  FOR FURTHER INFORMATION CONTACT:
   Sophia H. Twaddell
   Vice President, Corporate Communications
   [phone]
   

   Sharon L. Weinstein
   Noonan Russo
   [phone]
   

DATASOURCE: Northfield Laboratories Inc.



CONTACT:  Sophia H. Twaddell, Vice President, Corporate Communications of

Northfield Laboratories Inc., [phone], ;

or Sharon L. Weinstein of Noonan Russo for Northfield Laboratories Inc.,

[phone], 



Web site:  http://www.northfieldlabs.com/ 

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