Northfield Laboratories Inc. Presentation at FDA/NIH Workshop on Hemoglobin-Based Oxyge...(scene of injury. Thestudy was conducted ...),Health

Date:4/29/2008

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
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