Alliance Pharmaceutical appeals German ethics decision on phase 2 trial of Oxygent

New York, July 31 - Alliance Pharmaceutical Corp. said it has appealed the decision by the German ethics committee to refuse permission for its planned phase 2 trial of Oxygent (perfluorochemical emulsion) to prevent post-op ileus resulting from hypoxia during major surgery.

The committee's decision was based on the risks versus the benefits of the proposed trial.

Alliance has permission from the German Competent Authority and the French ethics committee to proceed with the trial and is waiting for a decision from the French Competent Authority.

The phase 2 study is intended to show safety and demonstrate the efficacy of Oxygent to improve post-op gut function.

Approximately 65 patients are expected to take part.

Alliance now expects the earliest it can start the trial is the fourth quarter. It noted it has sufficient funds if the study starts in that timeframe.

Alliance is a San Diego-based pharmaceutical company currently focused on developing its lead product, Oxygent, which is based on its proprietary perfluorochemical technology.

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