Alliance Pharmaceutical appears to have become the latest company tosuffer a setback in the bid to develop an alternative to whole blood for use in surgery. The firm's shares lost 68% of their value on January 9 to reach $2.38, a fraction of its 52-week high of $20.75, after it called a halt to a study looking at the safety and efficacy of its Oxygent (perflubron emulsion) blood substitute in patients undergoing cardiac surgery.
The suspension of patient enrollment has come about because of "an imbalance in certain adverse events, primarily the incidence of stroke," in patients receiving the blood substitute. The company said that while the incidence of these events in the Oxygent group was in accordance with published data for patients undergoing cardiac bypass surgery, the control group frequency was "remarkably low."
Alliance notes that the study investigators have not attributed the side effects to the use of Oxygent, which has now been evaluated in 19 clinical studies involving more than 1,400 subjects. Moreover, such reactions were not apparent in a completed Phase III study involving 492 general surgery patients that demonstrated significant reduction and avoidance in blood usage compared to the control population. This suggests that the finding could be a statistical aberration, said the firm.
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