Northfield Labs to defer decision on fast-track designation until endpoint is determined

By Jennifer Lanning Drey

Portland, Ore., Oct. 11 - Northfield Laboratories Inc. has agreed with the Food and Drug Administration to defer a decision on its application for fast-track designation for PolyHeme in the hopes that its Biologics License Application will be granted priority review status, according to Steven A. Gould, Northfield's chief executive officer.

Northfield and the FDA have agreed to defer the decision until PolyHeme's specific endpoint and indication, which would be the basis of the fast-track designation, have been determined, Gould said Wednesday during the company's fiscal first-quarter 2007 earnings conference call.

"Our real goal was, and continues to be, priority review of the BLA," Gould said.

Northfield's pivotal phase 3 trial of PolyHeme has dual primary endpoints of superiority and non-inferiority, and the breadth of the label indication that Northfield will seek for PolyHeme will be dependent on the outcome of the pivotal trial, Gould said.

"The real issue here is with two endpoints that are still potentially out there - only one of them which will satisfy - as we understood these nuances we thought it was perfectly reasonable to defer the decision," Gould said.

Northfield is preparing to lock the database from the PolyHeme phase 3 pivotal trial and could report top-line results from the study as early as November, Gould said.

A more detailed analysis of the trial would then follow.

PolyHeme is an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss. Northfield applied for fast-track designation of PolyHeme in August.

A fast-track designation facilitates the development and expedites the review of products that would treat serious or life-threatening conditions and address an unmet medical need. Under fast-track designation, a BLA is ordinarily eligible for priority review, Gould said.

Northfield's 720-patient phase 3 clinical trial for PolyHeme was designed to evaluate the safety and efficacy of the product when administered to patients in hemorrhagic shock following traumatic injury.

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

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