NEW YORK, Dec. 21, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) appointed Gregory Gores, M.D. to the Company's Medical Advisory Board.
"As a widely respected hepatologist and 2011 President of the International Liver Cancer Association (ILCA), Dr. Gores will contribute a wealth of clinical knowledge on hepatotoxicity and drug induced liver pathology to our Medical Advisory Board," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "His insight will help provide valuable support to the commercialization of the Delcath Hepatic CHEMOSAT® Delivery System in Europe and the rest of the world, as well as to our regulatory process in the United States."
Dr. Gores is the Reuben R. Eisenberg Endowed Professor in Gastroenterology and Hepatology, professor of Medicine, and chair of the Division of Gastroenterology and Hepatology at the Mayo Clinic in Rochester, Minnesota. His research is focused on the fundamental mechanisms underpinning cell death in the liver, employing models relevant to human disease. He has published more than 400 original articles, chapters, reviews, and editorials. Dr. Gores serves on the editorial boards for the American Journal of Physiology, American Journal of Gastroenterology, and Nature Reviews in Clinical Gastroenterology and Hepatology and is a past Associate Editor for Hepatology.
Dr. Gores has served as a standing member for two NIH Study Sections and recently chaired the Hepatobiliary Pathobiology Study Section. He has served on the Grants Review Committee for the American Liver Foundation. Dr. Gores is a past president of the American Association for the Study of Liver Diseases and has participated in many activities and committees of this organization. He has been elected into the honorific societies of the American Society for Clinical Investigation and the American Association of Physicians. He is a Mayo Distinguished Investigator.
"The efficacy results of Delcath's Phase 3 trial are impressive," said Dr. Gores. "I am excited to be joining Delcath's Medical Advisory Board. The Hepatic CHEMOSAT Delivery System provides a minimally invasive, repeatable means for delivering high-dose chemotherapy to the liver and has the potential to complement existing systemic therapies that often fail to adequately treat primary or metastatic liver tumors. This is an innovative technology, and I look forward to contributing to its clinical and commercial development."
About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other chemotherapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT Delivery System in April 2011. The Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at http://www.delcath.com/.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the future initial launch and distribution of the CHEMOSAT system Europe, CE Marking for the Generation Two system and the timing of our commercial launch in Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.Contact Information:Investor Contact:
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|SOURCE Delcath Systems, Inc.|
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