Gentium's Defibrotide Highlighted at American Society of Hematology Annual Meeting.VILLA GUARDIA (COMO), Italy -- Gentium S.p.A. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :GENT) (the "Company") today reported that its lead investigational product, Defibrotide, will be the subject of 10 presentations and three publications at the American Society of Hematology's (ASH) 48th Annual Meeting and Exposition being held at the Orange County Conference Center in Orlando, Florida, December 9-12, 2006. On Saturday, December 9, 2006, the following three poster presentations will be available for review from 9:00 a.m. to 7:30 p.m. in Hall E1: * "Defibrotide Does Not Cross-React with HIT Antibodies. Implications in the Management of HIT;" (Board #182-I) * "The South East England South East England is one of the nine official regions of England. It was created in 1994 and was adopted for statistics in 1999. Its boundaries include Berkshire, Buckinghamshire, East Sussex, Hampshire, Isle of Wight, Kent, Oxfordshire, Surrey and West Sussex. Thrombotic Thrombocytopenic Purpura thrombotic thrombocytopenic purpura n. A disease of unknown origin, characterized by abnormally low levels of platelets in the blood, the formation of blood clots in the arterioles and capillaries of many organs, and neurological damage. Registry" (Board #192-I) * "Inhibition of Heparinase I by Defibrotide with Potential Clinical Implications" (Board #754-I) On Sunday, December 10, 2006, from 4:30 p.m. to 6:00 p.m. in Room 312, Dr. Paul Richardson, M.D., Clinical Director of Dana-Farber Cancer Institute's Jerome Lipper Multiple Myeloma Center, Assistant Professor of Medicine at Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. and the Principal Investigator for the U.S. Phase III trial of Defibrotide in Severe VOD See video-on-demand. VoD - video on demand , will present an Oral Session entitled, "Defibrotide (DF) for the Treatment of Severe Veno-Occlusive Disease (sVOD) and Multi-Organ Failure (MOF (1) (Managed Object Format) An ASCII file that contains the formal definition of a CIM schema. See CIM. (2) (Meta Object F ) Post SCT Sacrococcygeal teratoma (SCT) A tumor occurring at the base of the fetus's tailbone. Mentioned in: Prenatal Surgery : Final Results of a Multi-Center, Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , Dose-Finding Trial." On Monday, December 11, 2006, the following six poster presentations will be available for review from 10:30 a.m. to 7:00 p.m. in Hall E1: * "Defibrotide Effectively Prevents Veno-Occlusive Disease of the Liver (VOD) after Allogeneic Stem Cell Transplantation Stem Cell Transplantation Definition Stem cells are basic human cells that reproduce (replicate) easily, providing a continuous source of new, sometimes different types of cells. . An Extended Study." (Board #191-III) * "High Dose Defibrotide as Therapy for Pediatric Patients with Veno-Occlusive Disease of the Liver." (Board #192-III) * "Prophylactic Defibrotide in Allogeneic Stem Cell Transplantation: Low Morbidity and Zero Mortality from Veno-Occlusive Disease." (Board #197-III) * "In Vitro Monitoring of Defibrotide Prophylaxis for Endothelial Complications Following Allogeneic Stem Cell Transplantation." (Board #198-III) * "Defibrotide (DF), an Orally Bioavailable Modulator of Myeloma Tumor-Microenvironment Interactions: Molecular Sequelae sequelae Clinical medicine The consequences of a particular condition or therapeutic intervention and Clinical Implications." (Board #752-III) * "A Multi-Center Phase I/II Study of Melphalan, Prednisone prednisone (prĕd`nĭsōn): see corticosteroid drug. , Thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that and Defibrotide in Advanced Multiple Myeloma Patients." (Board #789-III) The following three studies will be available in publication form at the meeting: * "Stem Cell Transplantation in Children with Infantile Osteopetrosis Is Associated with a High Incidence of VOD, Which Could Be Prevented with Defibrotide." * "Defibrotide for the Treatment of Hepatic Veno-Occlusive Disease in Children." * "Monitoring Immune Function by the Cylex Immuknow Assay in Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. HSCT HSCT Hematopoietic Stem Cell Transplant HSCT High Speed Civil Transport HSCT High School Competency Test HSCT Hypersonic Commercial Transport HSCT Hygiène Sécurité Conditions de Travail en Collectivité Territoriale HSCT Hayling Sentence Completion Task Patients." Laura Ferro, M.D., Gentium's president and chief executive officer, said, "We are very proud to have Defibrotide highlighted in such an extensive mix of oral sessions, poster presentations and publications at this year's ASH meeting. The volume of clinical data being presented underscores the potential therapeutic value of Defibrotide in a growing number of important clinical indications, including for the treatment and prevention of VOD and for the treatment of multiple myeloma. "We are particularly pleased with the data to be discussed at ASH from an independent Phase I/II study of Defibrotide to treat multiple myeloma in combination with melphalan, prednisone and thalidomide underway in Italy. These positive top-line results from the Phase I segment of this trial are very encouraging, and we look forward to the commencement of the Phase II segment of this study. "We continue to make progress with our U.S. Phase III trial of Defibrotide to treat Severe VOD, and look forward to building upon the compelling results from our U.S. Phase II study of Defibrotide to treat this devastating and often fatal disease," concluded Dr. Ferro. About Gentium Gentium, S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the research, discovery and development of drugs to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status and Fast Track Designation by the U.S. Food and Drug Administration to treat Severe Veno-Occlusive disease (VOD) and Orphan Medicinal Product Designation by the European Commission both to treat and to 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 Form 20-F for the year ended December 31, 2005 under the caption "Risk Factors." Source: Gentium |
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