Biopure continues Phase III trial for Hemopure:
This article was originally published in Clinica
Executive Summary
Biopure is continuing a Phase III clinical trial of its investigational oxygen therapeutic Hemopure, following an independent panel review of safety data from the halfway point of the trial. The single-blind, 640-patient study is evaluating Hemopure, which consists of ultrapurified bovine haemoglobin, as a room temperature-stable, universally compatible alternative to red blood cell transfusion in orthopaedic surgery at more than 40 sites in the US, Canada, Europe and South Africa. The Cambridge, Massachusetts-based company expects to submit the product to the US FDA for market go-ahead this year.