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Blood Substitutes

Phase III PolyHeme Trials Cleared by FDA

Published in AIDS Weekly, April 21st, 1997

Northfield Laboratories, Inc., Evanston, Illinois, has received clearance from the U.S. Food and Drug Administration (FDA) to begin Phase III trials of PolyHeme.

PolyHeme is a blood substitute. The pivotal trials, the first Phase III studies to include direct replacement of blood in large volumes, mark a milestone in medicine's search for an oxygen-carrying blood substitute, the company said.

Under the Phase III protocol cleared by the FDA, surgical patients are infused with six units of PolyHeme, Northfield's proprietary blood substitute. The six-unit level (3 liters containing 300 grams of hemoglobin) represents approximately 60 percent of an...

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