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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial in Trauma Patients Remains on FDA Hold
Date:5/18/2009

CAMBRIDGE, Mass., May 18 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) 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, including the most recent, 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 also developed and submitted a protocol for a trial proposed to be conducted in the field, called Operation RESUS (OP RESUS). 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 fluids." Op RESUS is also on clinical hold, and the company does not expect the FDA to permit RESUS or OP RESUS to proceed in the foreseeable future.

The company expects the NMRC to seek FDA approval for a clinical trial of Hemopure with a concomitant drug to address vasoactivity, which occurs with the use of Hemopure alone. The NMRC and the FDA are in discussions concerning such a trial, and the NMRC is
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