VILLA GUARDIA (COMO), Italy, April 9, 2013 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that the Company's lead product, Defibrotide, was the subject of two symposia during the 39th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) and the 29th Annual Nurse Group Meeting of the EBMT, both taking place this week in London, England.
The April 8th symposia, "Understanding and managing veno-occlusive disease (VOD)," was chaired by Professor Selim Corbacioglu (Children's Hospital Regensburg, Germany) and Professor Tony Pagliuca (Department of Haematological Medicine, King's College Hospital, London), and covered VOD's pathophysiology and case studies as well as the latest clinical information and cost-effectiveness of Defibrotide.
- Dr. Enric Carreras (Hospital Clinic Barcelona, Spain; Director Spanish Bone Marrow Donor Program), in, "Understanding the pathophysiology of VOD and the importance of the endothelium," presented results of ex vivo and in vitro studies exploring the disease's pathogenesis and Defibrotide's possible mode of action in preventing endothelial damage.
- The presentation of Dr. Paul Richardson (Harvard Medical School; Dana Farber Cancer Institute, Boston, USA), "Protecting the endothelium and restoring the thrombotic-fibrinolytic balance in VOD to improve patients outcomes," highlighted possible points for intervention in VOD and the need to move beyond purely supportive care. Dr. Richardson also provided an update on Defibrotide's clinical activity.
- In "Active management of VOD can be cost-effective and affordable," Professor Tony Pagliuca outlined the high cost of post-transplant complications, and explained how Defibrotide's clinical effectiveness translates into practical cost-effectiveness in this setting.
- Lastly, Professor Selim Corbacioglu and Dr. Victor Noriega (King's College Hospital, London) presented VOD case studies reviewing the risk factors and indications for prevention and also the importance of early diagnosis and treatment.
The April 9th Nurses symposia, "Veno-occlusive disease: a significant and potentially life-threatening complication of haematopietic stem cell transplantation," was chaired by Elisabeth Wallhult (President of the EBMT Nurses Group, Sahlgrenska University Hospital, Gothenburg, Sweden) and focused on how nurses can best identify and then support patients with VOD.
- In, "VOD: a potentially life-threatening early complication of HSCT," Dr. Sarah Marktel (Pediatric Immunohematology and Bone Marrow Transplantation Unit, San Raffaele Scientific Institute, Milan, Italy) discussed the disease's clinical presentation, classification, risk factors, and treatment options.
- Jennifer Cooper (The Great North Children's Hospital, Royal Victoria Infirmary, Newcastle upon Tyne, England), in "The importance of active management of patients with VOD," explained the nursing assessment and nursing intervention for VOD patients in her center.
- Bringing these themes together, Elisabeth Wallhult and Jennifer Cooper presented case studies about the challenges and importance of early VOD diagnosis, and the role that Defibrotide can play in the prevention and treatment of this disease.
Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.
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. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency, both to treat and to prevent VOD, as well as Fast Track Designation by the U.S. FDA to treat VOD.
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."