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Biopure Corporation (BPUR) announced that the FDA 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) under a proposed protocol submitted to the FDA in March 2009. 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.
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 conducting preclinical studies recommended by the FDA to prepare for such a trial. The NMRC continues to buy Hemopure for this testing.
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