Gentium Presents Additional Efficacy And Safety Data On Defibrotide At The American Society Of Hematology
VILLA GUARDIA, Italy, Dec. 7, 2010 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that three abstracts on Defibrotide were presented at the 52 nd Annual Meeting and Exposition of the American Society of Hematology held at the Orange County Convention Center in Orlando, Florida, December 4-7, 2010.
Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute, Boston, MA (USA), reported in an oral presentation the results of an interim analysis of the ongoing Treatment IND (T-IND) Expanded Access Protocol. The interim analysis reported results of 104 patients with severe Veno-Occlusive Disease (sVOD) with Multi-Organ Failure (MOF). Patients were enrolled at 36 US institutions between December 2007 and September 2009, 31 patients (30%) achieved a complete response (CR) by D+100, 33 patients (32%) survived to Day + 100 post SCT. Similar to the Phase III results, less sick patients responded better: patients who were not on dialysis or were not ventilator dependent at study entry had a higher CR rate compared to patients who were (41% vs 23%). In this population, no unexpected toxicities were observed and Defibrotide-associated toxicities were consistent with prior studies.
Dr. Richardson also reported in a poster presentation the results of a meta-analysis pooling data from matched patients with severe VOD with MOF in the Phase II and III studies (n= 133). Results were compared to the Historical Control (HC) group from the original Phase III study (N=32). Findings from this meta-analysis were consistent with results reported from previous studies; with improved outcomes of CR and survival by Day + 100 post SCT. CR in treated patients was 29% vs. 9% in the HC (p=0.0021 by propensity adjusted score), survival at Day + 100 was 40% vs. 25% (p= 0.0408). Similar with other studies, patients who were less severely compromised (those patients who were not on dialysis or ventilator dependent at study entry) had improved outcomes (CR rate 35% vs 10%; p=0.0006). The data presented by Dr. Richardson also supported the results of a recent randomized prophylactic study ( Corbacioglu et al, EBMT 2010), confirming that Graft-versus-Host Disease (GvHD) was less common in Defibrotide treated patients compared to HC (6% vs 25%).Enrollment into the T-IND study continues and, following the amendment effective at the end of September 2009, entry criteria for the T-IND study were expanded to permit enrollment of patients with less severe VOD and VOD post chemotherapy.
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