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Gentium S.p.A. (AMEX:GNT) (the "Company") today reported that an independent study of Defibrotide was the subject of a published paper titled "Successful Treatment with Defibrotide for Sinusoidal Obstruction Syndrome (also known as Veno-Occlusive Disease or "VOD") after Hematopoietic Stem Cell Transplantation (SCT)," which appeared in the December 2005 issue of Kobe Journal of Medical Science. The lead author of the paper was Kimikazu Yakushijin, Division of Endocrinology/Metabolism, Neurology and Hematology/Oncology, Department of Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Japan. Certain high dose chemotherapy and radiation therapies and stem cell transplantation (SCT) can damage cells of the blood vessels and result in VOD, a blockage of the small veins of the liver which can lead to liver failure and the failure of the kidneys and other organs. SCT is a frequently used treatment following high dose chemotherapy and radiation therapy. Based on the Company's review of more than 200 published papers, approximately 20% of patients who undergo SCT develop VOD, approximately one-third of those who develop VOD progress to multiple organ failure (Severe VOD), and approximately 80% of Severe VOD patients die within 100 days of the SCT. There are currently no approved therapies to treat or prevent VOD in the U.S. or the E.U. According to the published study, all patients showed evidence of multiple organ failure at the start of treatment, four patients were treated with Defibrotide for 14 to 27 days, three patients (75%) responded to the therapy, two patients survived at 100 days post SCT (50%), and none of the patients suffered from significant adverse effects. The paper concluded that this is the first report dealing with the use of Defibrotide to treat Japanese patients with VOD and because Defibrotide is considered to be promising for the treatment of VOD, it is important that further studies be initiated as soon as possible in Japan. Commenting on the publication, Dr. Laura Ferro, chairman and chief executive officer of Gentium, stated, "We were pleased with Dr. Yakushijin's independent study as it builds on our body of clinical evidence that supports the use of Defibrotide to treat Severe VOD. Data from Harvard University's Dana Farber Cancer Institute's U.S. Phase II study showed an increase in survival rate at 100 days post SCT of approximately 39%, compared with the historical 100-day survival rate of approximately 20%." Defibrotide to Treat Severe VOD The Company is awaiting Institutional Review Board approval for its pivotal U.S. Phase III trial of Defibrotide to treat Severe VOD and expects to initiate that trial in the coming weeks. Defibrotide to Prevent VOD The Company recently initiated a Phase II/III trial with Defibrotide to prevent VOD in pediatric patients. The randomized study will include 270 pediatric patients undergoing SCT at 30 clinical sites in Europe and Israel and will evaluate the ability of Defibrotide to prevent VOD. The Company plans to initiate a Phase II/III trial with Defibrotide to prevent VOD in adult patients in Europe during the second quarter of 2006 and in the U.S. by early 2007. About Defibrotide Defibrotide is a single-stranded DNA that protects the vascular endothelial cells, particularly those of small vessels, from damage and activation. After binding to endothelial cells, Defibrotide decreases cell adhesion and pro-coagulant activity of activated endothelial cells, and increases the fibrinolytic potential of endothelial cells. Defibrotide's effects are predominately local within the vascular bed, and there is no significant effect on systemic coagulation. Its beneficial pharmacological effects are due to its anti-thrombotic, anti-inflammatory and anti-ischemic properties. About VOD VOD is a potentially life-threatening condition. The International Bone Marrow Transplant Registry estimated that approximately 45,000 people received blood and bone marrow transplants in 2002. Certain high dose chemotherapy and radiation therapies and stem cell transplantation (SCT) can damage cells of the blood vessels and result in VOD, a blockage of the small veins of the liver which can lead to liver failure and the failure of other organs (Severe VOD). SCT is a frequently used treatment following high dose chemotherapy and radiation therapy. Based on the Company's review of more than 200 published papers it is estimated that approximately 20% of patients who receive SCT contract VOD. Approximately 80% of patients who contract Severe VOD die within 100 days of SCT. VOD is considered one of the most important and challenging complications of SCT. There currently are no approved therapies to treat or prevent VOD in the U.S. or the E.U. About Gentium Gentium S.p.A. is a biopharmaceutical company located in Villa Guardia (Como) that is focused on the research, discovery and development of drugs derived from DNA extracted from natural sources, and drugs that are synthetic derivatives, to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate in the U.S., is an investigational drug that has been granted Orphan Drug status by the U.S. FDA to treat VOD, Fast Track designation by the U.S. FDA for the treatment of Severe VOD in recipients of stem cell transplants, and Orphan Drug designation by European Union regulators to treat and prevent VOD. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements." 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 may differ, possibly 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 Prospectus filed with the Securities and Exchange Commission under Rule 424(b)(4) under the caption "Risk Factors."