VILLA GUARDIA (COMO), Italy, Dec. 7, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that an oral presentation and poster abstracts on Defibrotide will be presented at the 54th Annual Meeting and Exposition of the American Society of Hematology to be held at the Georgia World Congress Center in Atlanta, Georgia, December 8-11, 2012.
Results of a Large Prospective Study on the Use of Defibrotide in the Treatment of Hepatic Veno-Occlusive Disease (VOD) in Hematopoietic Stem Cell Transplant (HSCT). Early Intervention Improves Outcome – Updated Results of a Treatment IND (T-IND) Expanded Access Protocol.
Monday, December 10, 2012: 5:45 PM C101, Level 1, Building C. Paul G. Richardson, MD at Dana Farber Cancer Institute, Boston, MA.
Evaluation of Defibrotide in the Treatment of Hepatic Veno-Occlusive Disease (VOD) in non-Stem Cell Transplant (non-SCT) Chemotherapy Patients: Results from the Treatment IND (T-IND) Expanded Access Protocol and the Compassionate Use Program.
Sunday, December 9, 2012, 6:00 PM-8:00 PM Hall B1-B2, Level 1, Building B. Paul G. Richardson, MD at Dana Farber Cancer Institute, Boston, MA.
Defibrotide Interactions with Newer Oral Anticoagulants and Antithrombotic Agents.
Monday, December 10, 2012, 6:00 PM-8:00 PM Hall B1-B2, Level 1, Building B. Jawed Fareed, PhD et. al at Loyola University Medical Center, Chicago, IL.
For more details on the congress, please visit the official congress web site:
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.
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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.
Defibrotide has the potential to become the first drug approved for the prevention and treatment of hepatic veno-occlusive disease (VOD) a serious and potentially fatal complication of hematopoietic stem-cell transplantation (HSCT). The efficacy of Defibrotide to treat hepatic VOD in HSCT patients is supported by data from a multi-center Phase 3 historically controlled trial, evaluating Defibrotide for the treatment of severe VOD (patients with VOD and multi-organ failure), a Phase 2 dose finding study, and interim data reported from the ongoing Phase 3 expanded access U.S. Treatment IND program in patients with severe hepatic VOD. Additional data include a Phase 3 randomized controlled study of Defibrotide in the prevention of hepatic VOD in pediatric HSCT patients. Defibrotide has generally been well-tolerated in the clinical setting, and results in more than 1,300 patients to date have generally shown that Defibrotide does not appear to increase the risk of complications in HSCT patients.