Biopure: FDA committee to consider Navy's proposed 'Resus' trauma trial

By E. Janene Geiss

Philadelphia, May 26 - Biopure Corp. said Friday that it has been notified by the Food and Drug Administration that the FDA'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, according to a company news release.

The research center's Investigational New Drug application for Resus is on clinical hold at 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 Zafiris G. Zafirelis, Biopure chairman and chief executive officer, in the release.

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, officials said.

Biopure is a Cambridge, Mass., biopharmaceutical company that makes oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.