Gentium Announces Initiation Of Phase 1 Study In Japan

VILLA GUARDIA (COMO), Italy, March 26, 2013 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today has announced that the medical team from the National University Corporation Hamamatsu University School of Medicine ("HUSM"), Fukushima Medical University ("FMU) have successfully administered defibrotide to the first subject in the phase 1 clinical study.

This Investigator led clinical trial aims "to evaluate the Safety and Pharmacokinetics of Defibrotide (DF) in Healthy Adults." The trial has been adopted as a Health and Labour Sciences Research Grant in 2012 for Practical Use of Medical Technology (categorized as a study project to support practical drug/medical device use during the reconstruction of disaster-hit areas in eastern Japan).

Gentium is providing defibrotide and technical support to HSUM.  

About Gentium

Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD.

About Fukushima Medical University

Fukushima Medical University promote, through the highly advanced level of medical and nursing research of the faculty members, the welfare of the population of the prefecture and educate doctors and nurses to work for medical and welfare organizations in the prefecture after graduation. The University, its affiliated institute and hospital endeavour not only to carry out pioneering research that has gained worldwide recognition, but also to practice patient-oriented medicine with the highest ethical standards. Its ultimate goal is to fulfil its function of research and education for the local as well as international community

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