Phase III Trial Data Discrepancies Put Brakes on Northfield Labs’ Plan to Build Commercial-Scale Plant in Illinois

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas). Some discrepancies in Phase III clinical trial data regarding the PolyHeme, a human hemoglobin-based oxygen-carrying red blood cell substitute, have caused Northfield Laboratories (NYSE:NFLD) (Evanston, Illinois) to move out plans for the addition of a commercial-scale manufacturing plant. As tracked since 2004 in Industrial Info’s Pharmaceutical Tracker - Online Database, the company intends to construct a 100,000 unit per year plant on the site adjacent to an existing facility in Mount Prospect, Illinois. Northfield must correct the data, before releasing a final statistical analysis, followed by what is hoped to be an imminent FDA approval for PolyHeme.

As reported in January 2005 (see: Houston Participates in Controversial Phase III Clinical Trials for Blood Substitute PolyHeme), Northfield has received considerable heat over its trial methods, which ended in December 2006. PolyHeme was developed for use as a pre-hospital treatment of severely injured and bleeding patients when blood is needed, but not immediately available. Hoping to reach a minimum of 720 patients nationwide, the company had a total of eighteen test sites scattered among 32 Level 1 Trauma facilities throughout the country. The controversy arose over whether proper measures were being taken to assure patient consent prior to receiving the product.

The program Northfield used, which is approved by the Food and Drug Administration, allowed waiving the test subjects' informed consent in life-threatening situations. Others could choose to opt out of the program following response to public notices, most often published in local newspapers. It was the first study of its kind in evaluating an oxygen-carrying fluid at the time of injury, with treatment continuing up to twelve hours or a for a total of six units of PolyHeme. Traditionally, trauma patients sustaining severe blood loss receive a saline solution at the scene of the injury before being transported to the hospital where blood would then be available. As it is universally compatible, there is no need to cross-type for PolyHeme, making it immediately available for use as an initial resuscitative fluid. The potential benefits of the product increase substantially when considering battlefield applications.

Northfield is confident the trial data issues will easily be resolved, with FDA approval following shortly thereafter. Jacobs Engineering (Conshohocken, Pennsylvania) is serving as the project’s engineer and will resume planning the facility upon receiving further notice from Northfield. Construction was originally planned to begin early this summer, but has now been pushed out to later this year pending the FDA outcome.

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