FDA c'tee to consider Navy's proposed RESUS trauma trial

USA-based Biopure Corp says that it has been notified by the Food and Drug Administration that the agency's Blood Products Advisory Committee will meet on July 14 to discuss the Navy's proposed RESUS clinical trial of the company's investigational oxygen therapeutic Hemopure (hemoglobin glutamer - 250 [bovine]) for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury. The FDA has invited the Naval Medical Research Center and Biopure to present at the meeting. As previously announced, the NMRC's Investigational New Drug application for RESUS is on clinical hold at the FDA.

"We believe that the product holds promise as an emergency pre-hospital treatment until patients can receive blood or other standard treatment at a hospital, and we look forward to presenting our data," said Biopure chief executive Zafiris Zafirelis.

In order for the proposed RESUS trial to proceed, the FDA must lift the clinical hold and the Department of Defense and the institutional review boards of participating hospitals in the communities where the study would take place must provide final authorization, notes Biopure.