NEW YORK, Feb. 27, 2012 /PRNewswire/ -- Delcath Systems, Inc., (NASDAQ: DCTH) announced today that the first patients in Germany have been treated with the Delcath Hepatic CHEMOSAT® Delivery System at the Johann Wolfgang Goethe University Hospital, a premier European cancer treatment and research center located in Frankfurt. The cases were treated as part of the initial launch and training agreement the Company announced with the hospital in December 2011.
Two patients were treated for inoperable, liver-dominant metastases, one from cutaneous melanoma and one from breast cancer. The treating physicians reported that both patients were treated successfully without procedure-related complications.
Dr. Thomas J. Vogl, Director of the Institute for Diagnostic and Interventional Radiology at J.W. Goethe, said, "We believe this technology has significant potential to help control cancers in the liver. We're pleased to be the first cancer center to begin offering this important treatment option to patients in Germany, and are eager to further explore its role in the treatment of multiple tumor types including breast cancer."
"Delcath's partnership with J.W. Goethe reinforces the potential of CHEMOSAT," said Eamonn P. Hobbs, president and CEO of Delcath. "We recently treated our first patients in Milan and are eager to continue our expansion across Europe. Opening another CHEMOSAT treatment center and treating patients in the continent's largest market is another step forward in the commercialization of this technology."
About the Johann Wolfgang Goethe University Hospital
Founded in 1914, J.W. Goethe University Hospital is considered to be one of the leading university hospitals in Germany. Twenty-five research institutes working in close cooperation with the Medical Department bear witness to the hospital's strong academic approach. This makes sure that patients coming to the University Hospital for treatment enjoy the benefits resulting from timely implementation of research findings. Every year, around 47,200 and 220,000 patients respectively receive in- and outpatient treatment. The University Hospital possesses special interdisciplinary competence in the fields of neurological science, oncology and cardiovascular medicine.
About Delcath Systems
Delcath 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 therapeutic 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 announced that its randomized Phase III clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company also 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 right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at 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 use and adoption of the CHEMOSAT system by the J.W. Goethe University Hospital, patient outcome resulting from treatment with the CHEMOSAT system, future initial launch and training agreements with other cancer centers in 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.
Doug Sherk/Gregory Gin
|SOURCE Delcath Systems, Inc.|
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