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Trials & Filings

Gentium’s DF Passes Phase I in Japan

Safety, PK test successful

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Phase I trial of Gentium’s Defibrotide (DF) was completed by the Translational Research Center at the National University Corporation, Hamamatsu University School of Medicine (“HUSM”), Fukushima Medical University (“FMU”) in Japan.

The primary objective of the study was to evaluate the safety and pharmacokinetics of defibrotide in healthy Japanese adult subjects. The secondary objective was to evaluate the effect of defibrotide on the coagulation and fibrinolytic systems in vivo. Two dose levels (3 mg/kg and 6.25 mg/kg, termed Cohort 1 and Cohort 2, respectively) were evaluated, each cohort consisted of 10 subjects (8 subjects were given DF, 2 were given placebo).

All 20 subjects completed the protocol defined treatment and there were no premature discontinuations. No serious adverse events were noted and only one mild, transient and reversible adverse event observed. Moreover, no clinically significant changes were observed in laboratory test results in any of the dosing groups.

Defibrotide has been granted Orphan Drug status by the FDA and Orphan Medicinal Product Designation by the EMA both to treat and to prevent veno-occlusive disease (VOD) and Fast Track Designation by the U.S. FDA to treat VOD.

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