Northfield Laboratories seeks fast-track status for its red blood cell substitute PolyHeme

By Lisa Kerner

Charlotte, N.C., Aug. 8 - Northfield Laboratories Inc. said it has applied for fast-track designation from the Food and Drug Administration for PolyHeme for the treatment of life-threatening blood loss.

Fast-track facilitates the development and expedites the review of products for the treatment of serious or life-threatening conditions and address an unmet medical need.

"Now that the enrollment phase of our phase 3 trial is complete, we are focusing on the remaining steps necessary for submission of a BLA [Biologics License Application]," chairman and chief executive officer Steven A. Gould said in a company news release.

"We believe PolyHeme qualifies for fast-track designation based on its life-sustaining potential and we hope to be eligible for priority review when we submit our BLA next year."

PolyHeme is a solution of chemically modified human hemoglobin compatible with all blood types, according to Northfield.

Northfield announced the fast-track application at its Delivering Trauma Care Today and Tomorrow presentation to financial analysts and institutional investors in New York and via live webcast to its shareholders.

Northfield, based in Evanston, Ill., develops a red blood cell substitute.

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