Gentium Begins Expanded Access Program for Defibrotide

Italy’s Gentium has instituted an expanded access program as a corollary to its Phase III trial of defibrotide to treat veno-occlusive disease with multiple-organ failure.

Veno-occlusive disease occurs after high-dose chemotherapy and radiation therapies and stem cell transplantation. It causes blockage of the small veins of the liver that can lead to organ failure.

Gentium said it will collect data from the program to support its planned new drug application for this indication.