NAVY'S PROPOSED TRAUMA TRIAL UNDER REVIEW BY FDA

The FDA has notified the Navy that it would consult an advisory committee within six months to discuss the proposed "RESUS" clinical trial of Biopure's oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)] for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury.

Biopure, manufacturer of the drug, said the investigational new drug application (IND) for RESUS, submitted by the Naval Medical Research Center to the FDA in June 2005, remains on clinical hold because of issues related to the predicted risk-benefit profile of the product under the proposed protocol.

RESUS (Restore Effective Survival in Shock) is a government-funded study designed as a single-blinded, multicenter, randomized, controlled, Phase IIb/III clinical trial. The objective is to assess the safety and efficacy of Hemopure, as compared with standard treatment, in reducing morbidity and mortality in severely injured patients experiencing hemorrhagic shock (acute blood loss) in the out-of-hospital setting, where blood is not available for transfusion.

In the proposed study, patients would be randomized to receive either Hemopure or standard therapy (crystalloid solution) at the scene of the injury and during transport to the hospital. All patients would receive standard therapy (blood transfusion if indicated) upon arrival at the hospital.

Because patients would be unconscious or traumatized, the trial design provides an exception from informed consent and a community consultation and disclosure process, as defined in FDA regulation 21 CFR 50.24. ()a href="http://www.fdanews.com/ddl" target=_blank>