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NORTHFIELD LABS' BLOOD SUBSTITUTE PHASE I TRIALS

Executive Summary

NORTHFIELD LABS' BLOOD SUBSTITUTE PHASE I TRIALS are set to begin at Michael Reese Medical Center in Chicago. The studies, which are scheduled to start within the next few weeks, will involve fewer than 10 healthy male volunteers, the firm said. The blood substitute -- pyridoxylated, polymerized human hemoglobin balanced in an electrolyte solution -- has many advantages over whole blood, Northfield Labs maintained. "Our product offers oxygen carrying capacity, volume expansion and electrolyte balance comparable to whole blood, while virtually eliminating blood's limitations of short shelf life, disease transmission risk and compatibility issues," the company stated in a recent release. The production process involves "removal of the hemoglobin from red cells, treatment to destroy bacteria and viruses and incorporation into a solution which an be stored for extended periods." The company claims that the blood substitute has the potential to have a worldwide market of $10 bil. Northfield Labs also noted that "the product is the only blood substitute at this stage of clinical evaluation." Alpha Therapeutic, however, has an NDA pending for its oxygen transport product Eluosol-DA. According to Northfield Labs the initial research on the blood substitute began in 1970. Those studies were conducted at the University of Illinois' Medical Center and at Cook County Hospital, both of which are located in Chicago. The principal investigator, for the earlier and for the upcoming trials, is Gerald Moss, MD, Chairman, Department of Surgery, Michael Reese Medical Center. Northfield Labs is a privately held medical products company based in Northfield, Illinois whose primary interest is the development, testing and eventual marketing of the blood substitute.
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