Gentium S.p.A.

Gentium S.p.A. announced the completion of patient enrollment in a Phase II/III European, multi-center, open label, randomized trial to evaluate the prophylactic use of Defibrotide in pediatric patients undergoing stem cell transplantation who are at high risk for hepatic veno-occlusive disease (VOD). In the Phase II/III trial, patients are randomly assigned to one of two treatment arms. Those allocated to the Defibrotide prophylaxis arm receive 25mg/kg/day in four divided doses beginning at the time of conditioning and finishing 30 days after stem cell transplantation (SCT) or upon discharge from inpatient care. Patients allocated to the control arm do not receive VOD prophylactic measures. The primary efficacy endpoint for the trial is the incidence of VOD within 30 days after SC T. The secondary safety endpoints include the occurrence of multi-system organ failure and survival at 100 days after SCT. Gentium plans to release initial results of this trial at the Annual Meeting of the European Group for Blood and Marrow Transplantation, March 29 to April 1, 2009 in Goteborg, Sweden.