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U.S. Naval Medical Research Center Resubmits IND Application for Proposed 'Op RESUS' Clinical Trial in Trauma Patients in the Battlefield Setting
Date:12/2/2008

CAMBRIDGE, Mass., Dec. 2 /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 battlefield treatment of trauma patients. The study is entitled "Operation Restore Effective Survival in Shock" (Op RESUS).

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 hemorrhagic shock, when blood transfusion is not available. The proposed trial hypothesis is that for such casualties Hemopure will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with "standard fluid." If the trial is permitted to proceed, subjects will sign an informed consent prospectively. The revised Op RESUS protocol addresses some of the issues raised by the FDA on the initial filing.

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 use 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 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 t
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SOURCE Biopure Corporation
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