April 11, 2005
Northfield Laboratories Inc. Announces Result of Third Interim Analysis of PolyHeme Pivotal Phase III Study Data
Study Continues Without Modification; No Increase in Sample Size Required -
EVANSTON, Ill., April 11 /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 third planned interim analysis of the study data. The IDMC reviewed blinded data on mortality in the first 250 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 a Phase III clinical trial in the high-risk trauma population.
The IDMC also conducted an adaptive sample size determination as specified in the trial protocol. A blinded power analysis was performed to determine if any increase in the sample size of the study was necessary. The assessment was based on a comparison between the mortality rate predicted in the protocol and the observed mortality rate in the trial to date. The IDMC has concluded that no adjustment in the number of patients to be enrolled in the study is required. Therefore, trial enrollment remains at a total of 720 patients.
"This is another major milestone for Northfield," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We are extremely pleased with this third recommendation of the IDMC to continue our pivotal Phase III trial without modification. We look forward to the successful completion of the trial and are working diligently to reach this goal as expeditiously as possible."
The pivotal Phase III study is designed to evaluate the safety and efficacy of PolyHeme(R), Northfield'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 Level I trauma centers throughout the United States. 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. These "interim looks" are defined in the study protocol and are scheduled to take place after 60, 120, 250 and 500 patients are enrolled and followed for a 30-day period to assess survival. The IDMC reviews all safety data as the study proceeds, focusing on mortality and serious adverse events. Strict confidentiality of the data is maintained by the IDMC. Northfield receives a recommendation from the IDMC after each review, but does not have access to the actual data or the deliberations of the IDMC, and will remain shielded from the data until the study is complete. Patients continue to be enrolled in the study while the IDMC conducts its reviews of interim data.
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.
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 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.
For further information about Northfield Laboratories, visit http://www.northfieldlabs.com/
Steven A. Gould, M.D. Chairman and Chief Executive Officer (847) 864-3500 Sharon L. Weinstein Noonan Russo (212) 845-4271 firstname.lastname@example.org Sophia H. Twaddell Vice President, Corporate Communications (847) 864-3500 email@example.comSource: Northfield Laboratories Inc.
CONTACT: Steven A. Gould, M.D., Chairman and Chief Executive Officer, or
Sophia H. Twaddell, Vice President, Corporate Communications,
firstname.lastname@example.org, both of Northfield Laboratories Inc.,
+1-847-864-3500; or Sharon L. Weinstein, Noonan Russo, +1-212-845-4271,
Web Site: http://www.northfieldlabs.com/