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BPUR Biopure announces next steps for Navy's proprosed Resus Trauma Trial of Hemopure; Trial to be adapted as smaller, Phase II trial (0.57 )

Co announced that the Navy is in discussions with the Food and Drug Administration regarding potential protocol revisions to its previously proposed RESUS Phase IIb/III pre-hospital trauma trial of Hemopure that could enable RESUS to proceed as a smaller, Phase II trial, subject to FDA approval. The Navy and the FDA communicated following last week's meeting of the FDA Blood Products Advisory Committee, at which BPAC members discussed possible protocol modifications. Over the next several weeks, Biopure plans to work with the Naval Medical Research Center, which is sponsoring RESUS, to revise the study protocol and investigational new drug application for resubmission to the FDA and, subsequently, to the NMRC's own institutional review board. The trial will be modified as a Phase II study comprising a few hundred patients.