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Gentium Announces Initiation of Phase 1 study in Japan

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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

About The Health and Labour Sciences Research Grant

The aim of Health and Labour Sciences Research Grant is to promote the Health and Labour Sciences Research. By the promotion of Health and Labour Sciences Research, the Ministry of Health, Labour and Welfare secures the scientific promotion of the administrative purposes about the national healthcare, the welfare, Environmental Health, occupational safety and health and plans the improvement of the level of technology. The Ministry of Health, Labour and Welfare forms competitive study environment regarding some original or pioneer researches with strong social requests and advertises for research projects every year.

Cautionary Note Regarding Forward-Looking Statements

This release contains "forward-looking statements" that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of Gentium's securities. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to the possibility of any future regulatory approval, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our Form 20-F filed with the Securities and Exchange Commission under the caption "Risk Factors."

CONTACT: Gentium S.p.A. Salvatore Calabrese, +39 031-5373-260 SVP & CFO scalabrese@gentium.it or The Trout Group Tricia Swanson, +1 646 378 2953 TSwanson@troutgroup.com

Source:Gentium S.p.A.