EVANSTON, Ill., April 29 /PRNewswire-FirstCall/ -- Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that Steven A. Gould, M.D., Chairman and Chief Executive Officer, presented a talk on the clinical development of PolyHeme(R), the Company's investigational red cell substitute at an FDA/NIH Workshop on Hemoglobin-Based Oxygen Carriers. Dr. Gould's talk focused primarily on data from Northfield's trials in acute blood loss: earlier trials in hospitalized trauma patients and the recent U.S. Multicenter Trauma trial. The presentation is available on the Company website, http://www.northfieldlabs.com.
"The indication we are seeking for PolyHeme(R), the treatment of life-threatening hemoglobin levels when blood transfusion is required and red blood cells are not available or not an option, addresses a critical, unmet medical need and presents unique challenges for the conduct of clinical trials," said Dr. Gould.
Dr. Gould reviewed data from the study in hospitalized trauma patients, the results of which were published in the Journal of the American College of Surgeons in 2002. The study included 171 patients with acute blood loss who received up to 20 units of PolyHeme(R), or twice the blood volume of an adult, during ongoing bleeding. This study demonstrated the life-sustaining capability of PolyHeme(R) in patients with life-threatening red blood cell hemoglobin levels compared to historical controls who refused blood transfusion due to their religious beliefs.
In reviewing the data from the U.S. Multicenter study, Dr. Gould noted that Northfield's study was logistically complex, and was the first study of a red cell substitute in the U.S. to begin at the scene of injury. The study was conducted at 32 Level I trauma centers, enrolled 720 trauma patients, and included the participation of 300 ambulances and 3500 EMTs in addition to 150 principal investigators and thousands of allied hospital staff. The study compared the outcomes of patients receiving the current standard of care, salt water at the scene and during transport, followed by blood immediately upon arrival at the hospital, and patients who received PolyHeme(R) for up to a dose of six units or 12 hours following injury.
Dr. Gould focused his remarks on results in two analysis populations, the 714 patients who were analyzed As Randomized, and the 590 patients who were appropriately enrolled and treated as specified in the protocol (Per Protocol). The difference between the two populations was the 124 patients with major protocol violations, who were inappropriately enrolled or not treated according to the protocol. Dr. Gould noted that the results in the Per Protocol population, where all aspects of the protocol were followed, offer the clearest opportunity to assess a treatment effect of PolyHeme. These protocol violations had an important influence on the study results. In the PolyHeme group, there were more patients with protocol violations, there were more protocol violations per patient, and more of these patients had predictors of poor outcomes present prior to treatment.
New Data from Independent Data Monitoring Subcommittee on Cardiac Events
In reviewing safety data from the study, Dr. Gould reviewed the most commonly reported adverse and serious adverse events, providing new data on cardiac events.
He stated that in order to reconcile the disparity between the low number of reported myocardial infarctions (MIs) and the high incidence of abnormal EKGs and elevated cardiac enzymes, Northfield established an independent Cardiac Subcommittee of the IDMC to review, based on the available data, the cardiac profiles of all 720 enrolled patients in a blinded fashion. They used objective criteria to classify the MIs in the study as "possible," "probable," "indeterminate," and "absent." More than half the patients in both study groups had some evidence of myocardial infarction. [See table.]
"This is useful information, which confirms the difficulty of diagnosing cardiac ischemia in trauma patients," said Dr. Gould.
Dr. Gould concluded his presentation by summarizing the development of PolyHeme(R). "We believe our studies demonstrate that PolyHeme(R) offers a survival benefit in cases of life-threatening red blood cell hemoglobin levels and has an acceptable safety profile and favorable benefit-to-risk ratio when red blood cells are not available."
About Northfield Laboratories and PolyHeme(R)
Northfield Laboratories Inc. is a leader in developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. Northfield's product, PolyHeme(R), is under clinical investigation as oxygen-carrying red blood cell substitute. It 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. For further information, visit http://www.northfieldlabs.com.
Forward Looking Statement
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 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 the possibility that since the full data from our Phase III clinical trial have not been submitted to, or reviewed by, FDA, they may not be sufficient to demonstrate the safety or effectiveness of PolyHeme, our ability to successfully file a Biologics License Application, our ability to be granted priority review of our Biologics License Application, our ability to obtain FDA approval to market PolyHeme commercially, our need to obtain additional capital to finance our ongoing business operations and the construction of an expanded commercial- scale manufacturing facility, 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 outcome of certain governmental inquiries and purported class action lawsuit as described in our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q, 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 annual report on Form 10-K and annual report on Form 10-Q. 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.
SOURCE Northfield Laboratories Inc.
