defibrotide

(EMAILWIRE. COM, April 05, 2010) San Antonio, TX - Gentium S.p. A. (ADR) (Public, NASDAQ: GENT), is up 55% on Friday, is a biopharmaceutical company focused on the development and manufacture of defibrotide, a deoxyribonucleic acid (DNA) based drug derived from pig intestines, to treat and prevent a disease called hepatic veno-occlusive disease

The Earth Times Online Newspaper 2010

In this study, researchers from the University of Ulm in Germany assessed the safety and efficacy of defibrotide, an investigational drug, for the prevention of this disease in the largest-ever, international, multicenter study of high-risk pediatric patients undergoing stem cell transplants.

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"Our study confirms that defibrotide is safe and effective for preventing veno-occlusive disease in this high-risk population."

EurekAlert! - Breaking News 2009

Consistent with the role of defibrotide in protecting endothelial cells (the thin layer of cells that line the inside of blood vessels), both the incidence of renal failure (1 percent with defibrotide versus 6 percent in control) and also the overall incidence and severity of acute graft-versus-host disease (32 percent in defibrotide versus 43 percent in control) were significantly lower in the defibrotide arm.

EurekAlert! - Breaking News 2009

The patients who were randomized to the defibrotide arm received intravenous infusions (25 mg/kg/day) from the start of conditioning

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Patients were prospectively randomized prior to stem cell transplantation to receive either defibrotide or no preventive therapy for veno-occlusive disease.

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Consistent with the role of defibrotide in protecting endothelial cells (the thin layer of cells that line the inside of blood vessels), both the incidence of renal failure (1 percent with defibrotide versus 6 percent in control) and also the overall incidence and severity of acute graft-versus-host disease (32 percent in defibrotide versus 43 percent in control) were significantly lower in the defibrotide arm.

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According to the study results, preventive use of defibrotide resulted in a 40 percent reduction in the overall incidence of veno-occlusive disease in these pediatric patients.

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In addition, the safety of defibrotide was confirmed by the lack of significant toxicity; the defibrotide and control arms had similar numbers of adverse events reported.

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"Our study confirms that defibrotide is safe and effective for preventing veno-occlusive disease in this high-risk population."

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