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Alliance suspends Oxygent cardiac surgery trial:

This article was originally published in Clinica

Executive Summary

Alliance Pharmaceutical has suspended enrolment in a phase III trial of its oxygen-carrying therapeutic, Oxygent, in patients undergoing heart bypass procedures with cardiopulmonary bypass support. The suspension follows an unexpected difference in the incidence of adverse events (AEs), primarily stroke, between the treated patients and the controls. The frequency of AEs in the treatment group was in agreement with published data, but was remarkably low in the control group. The San Diego, California company says the study researchers have not attributed the use of Oxygent to the AEs and that an investigation into the imbalance will be set up.

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