Northfield gets FDA okay

            EVANSTON, IL - Northfield Laboratories Inc. received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase III trials of its blood substitute, PolyHeme (tm). The pivotal trials, the first Phase III study to include direct replacement of blood in large volumes, mark a milestone in medicine's search for an oxygen carrying blood substitute, Northfield said.   Under the Phase III protocol cleared by FDA, surgical patients will be infused with six units of PolyHeme, Northfield 's proprietary blood substitute. The six-unit level (3 liters containing 300 grams of hemoglobin) represents about 60% of an adult's entire blood volume. Northfield is reportedly the only firm to report success of this high dose limit in any phase of clinical testing, and the only firm to evaluate its oxygen carrier as a direct replacement for blood in high volumes in a Phase III study. The randomized, controlled study will include about 250 elective surgery patients and once underway is expected to take 12 months to complete.