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>
Dr. Selim Corbacioglu, Pediatrics, University of Regensburg (Germany)
and Principal Investigator of the Pediatric Prevention trial reported in
an oral presentation that on an intent to treat basis (ITT), Defibrotide
demonstrated a 40% reduction>
“I believe that the results of the pediatric prevention study, which is
the largest trial to date conducted in the pediatric bone marrow
transplant setting, confirmed that Defibrotide is well tolerated and is
effective in preventing VOD,” said Dr. Selim Corbacioglu. “Additionally,
we are enthusiastic that Defibrotide was able to significantly reduce
the incidence and severity of acute graft versus host disease, a life
threatening complication of stem cells transplants for which there are
limited, effective prophylactic and treatment options. This activity is
consistent with the drug’s role in the protection of endothelial cells.”
Dr. Paul G. Richardson, Clinical Director of the Dana-Farber Cancer
Institute’s Jerome Lipper Multiple Myeloma Center and Principal
Investigator of the Treatment trial reported in a separate oral
presentation that on an ITT basis, 24% of patients in the Defibrotide
arm compared to 9% of patients in the historical control arm achieved
complete response at 100 days>