Under the amended protocol, the primary endpoint for the 160-patient, historically controlled, multi-center Phase III study would change from survival at 100 days to complete response as defined by bilirubin < 2mg/dL and the resolution of multiple organ failure. Survival at 100 days will be evaluated as a secondary endpoint. Laura Ferro, chairman and CEO of Gentium, said: "We have spoken with various scientific and regulatory advisors, and we are comfortable with complete response as our primary endpoint. The impact of Defibrotide on complete response seen in our Phase II trial was highly correlated to survival at 100 days in severe veno-occlusive disease patients. To date, the trial has enrolled 65 of the expected 80 patients in its prospective arm and remains on track to report results during the first half of 2008."