Gentium Provides Update on Defibrotide Program

Italy’s Gentium will submit an amendment to the protocol for its Phase III trial of Defibrotide for the treatment of hepatic veno-occlusive disease with multi-organ failure to the FDA.

Under the amended protocol, the primary endpoint for the 160-patient, multicenter study would change from survival at 100 days to complete response as defined by bilirubin less than 2 mg/dL and the resolution of multiple organ failure. Survival at 100 days will be evaluated as a secondary endpoint.

Laura Ferro, chair and CEO of Gentium, said the trial remains on track to report results during the first half of 2008.