Gentium S.p.A. Initiates Phase II/III Pediatric Trial With Defibrotide To Prevent Veno-Occlusive Disease

VILLA GUARDIA (COMO), Italy--(BUSINESS WIRE)--Jan. 20, 2006--Gentium S.p.A. (AMEX:GNT) (the "Company") today announced the initiation of a Phase II/III trial with Defibrotide to prevent Veno-Occlusive Disease ("VOD"), a complication of bone marrow and stem cell transplantation (SCT), in pediatric patients. The randomized study will include 270 pediatric patients undergoing SCT at 30 clinical sites in Europe and Israel and will evaluate the ability of Defibrotide to prevent VOD. Secondary endpoints are measuring the severity of VOD and the occurrence of transplant-associated microangiopathy in each group. The European Group for Blood and Marrow Transplantation (EBMT) is co-sponsoring the study with additional support from the Deutsche Krebshilfe (German Cancer Aid). The principal investigator is Selim Corbacioglu, M.D., Dept of Pediatrics - University of Ulm, Germany.