The Navy and the FDA communicated following a meeting of the Blood Products Advisory Committee (BPAC). The BPAC voted against proceeding with the proposed phase IIb/III trial. Committee members suggested that, in view of the product’s potential benefit, the trial be modified as a pre-hospital phase II study designed to provide safety and efficacy data in a few hundred patients.
Biopure plans to work with the Naval Medical Research Center to revise the study protocol and investigational new drug application for resubmission to the FDA.
The trial will be modified as a phase II study comprising a few hundred patients. Other changes to consider, based on the BPAC discussion, include adjusting the trauma score, age inclusion criteria, and pre-hospital transportation time. The BPAC also discussed incorporating some military operational aspect into the Navy’s trauma development program for Hemopure.
In order for the trial to proceed, the FDA must lift its clinical hold and the Department of Defense and the institutional review boards of participating hospitals must provide final authorization.