Biopure reports proof-of-concept data from Phase II coronary trial

The study, COR-0002 trial, is a single-blind, open-label, single-center, cross-over pilot study where subjects underwent coronary balloon occlusion, with and without oxygenated HBOC-201. The primary objective of the study was to test the hypothesis that intracoronary infusion of HBOC-201 during brief, total coronary artery occlusion would preserve left ventricular function. The primary endpoints in COR-0002 were left ventricular diastolic relaxation indices as assessed by left ventricular pressure-volume loops and ST segment changes as assessed via electrocardiograms.

The study concluded that HBOC-201 was indeed capable of preserving left ventricular function, likely through maintenance of myocardial oxygenation. According to the findings, the absence of coronary vasoconstriction, despite exposure to undiluted HBOC-201, further supports the potential utility of HBOC-201 in complicated patient subsets such as those with coronary artery disease.

In addition, changes in electrocardiograms, indicating severe ischaemia during control coronary artery occlusions, were not present during or following HBOC-201 infusion. The report states that HBOC-201 did not cause any serious adverse event or significantly alter blood chemistry parameters through the four-day follow-up period.