Gentium 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, multicenter trial will be compared to an historical control group of 80 patients, with survival at day 100 as the primary endpoint. Approximately 80 percent of patients with Severe VOD die within 100 days of SCT without treatment.
The trial will be conducted at approximately 20 U.S. cancer centers pending the IRB approval at each institution.