VILLA GUARDIA (COMO), Italy--(BUSINESS WIRE)--March 28, 2006--Dana-Farber/Harvard Cancer Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center and The Children’s Hospital Receive IRB Approval to Commence Study. Gentium S.p.A. (AMEX:GNT) (the Company) has received its first Institutional Review Board (IRB) approval to initiate a U.S. Phase III clinical trial with Defibrotide for the treatment of Veno-Occlusive Disease (VOD) with Multiple Organ Failure (Severe VOD) as a complication of stem cell transplantation (SCT). Data from this 80-patient, multi-center trial will be compared to an historical control group of 80 patients, with survival at day 100 as the primary endpoint. The Company believes that approximately 80% of patients with Severe VOD die within 100 days of SCT without treatment. The Company believes that there are no approved treatments for Severe VOD.
