A blood-letting problem

It sometimes happens that protocols designed to help patients turn out to do more harm than good. That apparently was the case in a Phase III trial of Alliance Pharmaceutical Corp.'s Oxygent blood substitute in cardiac bypass surgery patients. The good news for ALLP is that Oxygent itself apparently was not responsible for the higher incidence of stroke in treated patients versus controls. The bad news is that the company is likely to do a new Phase III study, which would set back its timeline for completing Phase III trials by about 18 months.

In January, ALLP voluntarily suspended enrollment in a Phase III trial of the perflubron emulsion blood substitute in patients undergoing cardiac surgery with cardiopulmonary bypass (CB) after seeing a higher incidence of stroke in treated patients. ALLP said the control group also experienced a lower-than-expected incidence of stroke (see BioCentury, Jan. 16). ...