FDA COMMITTEE RECOMMENDS AGAINST BIOPURE'S HEMOPURE STUDY

Biopure has announced that the FDA's Blood Products Advisory Committee voted 11-8 to recommend against proceeding with the Navy's proposed Phase IIb/III, 1,100-patient study of Biopure's oxygen therapeutic Hemopure (hemoglobin glutamer 250 (bovine)) for the pre-hospital treatment of hemorrhagic shock resulting from traumatic injury. In view of the product's potential benefit in this patient population, committee members suggested that a pre-hospital Phase II/IIb study be designed to provide both safety and efficacy data in a smaller patient population.

The recommendation, which is not binding on the FDA, came after Dec. 14 hearing at which the committee discussed preclinical and clinical data. During its deliberations, the committee questioned whether existing data justify a Phase III trial to be conducted under the federal regulation (21 CFR 50.24) allowing for exception to informed consent in patients who are unable to provide adequate consent given the nature of their injuries.

"Although the committee advised against RESUS moving forward, we view its comments today as constructive criticism and generally supportive of the product's development for the emergency pre-hospital treatment of trauma patients," Biopure Chairman and CEO Zafirelis Zafirelis said after the meeting.

Hemopure is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is also developing Hemopure for a potential indication in cardiovascular ischemia.