VILLA GUARDIA (COMO), Italy--(BUSINESS WIRE)--Gentium S.p.A. (NASDAQ: GENT) today announced final clinical trial results from the Company’s Phase II/III Pediatric Prevention trial and Phase III Treatment trial for Defibrotide of Hepatic Veno-Occlusive Disease (VOD), which were presented at the American Society of Hematology Conference (ASH) in New Orleans. The results of both trials strongly trended toward statistical significance. The Prevention trial demonstrated a 40% reduction in the incidence of VOD at day 30 (p=0.0488 Competing Risk; p=0.0507 Kaplan-Meier) and the Treatment trial showed an improvement in complete response from 9% in the historical control arm to 24% in the Defibrotide arm (p=0.0148). Defibrotide was well tolerated in both studies.
