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U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'RESUS' Clinical Trial in Trauma Patients in the Out-of-Hospital Setting
Date:3/23/2009

CAMBRIDGE, Mass., March 23 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the U.S. Naval Medical Research Center (NMRC) has submitted to the Food and Drug Administration (FDA) a revised investigational new drug (IND) application to conduct a clinical trial of the company's oxygen therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the pre-hospital treatment of trauma patients. The study is entitled "Restore Effective Survival in Shock" (RESUS). The RESUS trial was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission was placed on clinical hold.

Under a research agreement with Biopure, the NMRC assumed primary responsibility, subject to funding, for designing, seeking FDA acceptance of and directing a trial for Hemopure's prehospital used in trauma patients with hemorrhagic shock. The NMRC has developed protocols for trials in civilian casualties in the United States and abroad (RESUS) as well as a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). To date, Congress has appropriated funds for the development of Hemopure for potential use in military and civilian trauma indications and to cover military administrative costs. This funding is being used for trial preparation and for preclinical studies of Hemopure in animal models, including those that mimic military trauma scenarios.

As previously reported, in June 2008 the NMRC submitted and subsequently withdrew an Op RESUS protocol for a Phase 2 clinical trial of Hemopure for resuscitation of operations casualties with severe traumatic hemor
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SOURCE Biopure Corporation
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