Gentium (GENT) Reports Publication of Encouraging Defibrotide Results on VOD in Certain Patients
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Gentium S.p.A. (Nasdaq: GENT) reports that results from a Phase III randomised controlled trial which evaluated Defibrotide for use in preventing hepatic veno-occlusive disease (VOD) in paediatric patients undergoing haemopoietic stem-cell transplantation (HSCT) were published in the medical journal, The Lancet (Vol 379). The results of Corbacioglu et al. show that Defibrotide leads to a 40% a reduction in the incidence of VOD thirty days after HSCT in patients receiving Defibrotide, compared with those who did not receive Defibrotide. Additionally, in allogeneic HSCT recipients (70% of study population), the incidence and severity of acute graft-versus-host disease (GvHD) were significantly lower in the Defibrotide arm. These finding supports the prophylactic use of Defibrotide in the HSCT transplant setting.
In a commentary article to the study, Drs. Uwe Platzbecker and Martin Bornhauser from Medizinische Klinik und Poliklinik I, Universitatsklinikum "Carl Gustav Carus" Dresden, Germany, conclude "Most importantly, defibrotide prophylaxis was well tolerated and did not lead to an increased risk of bleeding. Restriction by the legislative authorities means that there are few randomised trials in children, and thus Corbacioglu and colleagues' investigation is a pivotal European study, one that will hopefully change practice in paediatric patients and might also provide an impetus to investigate treatment options for adult patients."
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In a commentary article to the study, Drs. Uwe Platzbecker and Martin Bornhauser from Medizinische Klinik und Poliklinik I, Universitatsklinikum "Carl Gustav Carus" Dresden, Germany, conclude "Most importantly, defibrotide prophylaxis was well tolerated and did not lead to an increased risk of bleeding. Restriction by the legislative authorities means that there are few randomised trials in children, and thus Corbacioglu and colleagues' investigation is a pivotal European study, one that will hopefully change practice in paediatric patients and might also provide an impetus to investigate treatment options for adult patients."
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