NEW YORK, March 27, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Company has entered into an initial launch and training agreement for the Delcath Hepatic CHEMOSAT® Delivery system with the Istituto Nazionale Tumori Fondazione G. Pascale in Naples, Italy. The center pursues both clinical and applied research in cancer treatment and is Southern Italy's largest Scientific Institute for Research, Hospitalization and Health Care (IRCCS) in oncology.
The CHEMOSAT program at G. Pascale will be led by Paolo Ascierto, MD, medical oncologist and Prof. Nicola Mozzillo, MD, surgical oncologist. Drs. Ascierto and Mozzillo are both directors in the center's department of melanoma, soft tissues, musculo-skeletal and head and neck.
"We are extremely pleased to enter into an agreement with Delcath to bring chemosaturation to patients in our region," Dr. Ascierto said. "CHEMOSAT has the potential to meet an unmet treatment need for patients at our center – and beyond. We anticipate that the delivery system will help us tremendously in the clinical setting."
Under the terms of the agreement, Delcath will provide G. Pascale with logistics and clinical training support in the performance of chemosaturation therapy using the CHEMOSAT system. Training is expected to take place in May.
"This new agreement speaks to our commitment to advancing the standard of patient care through innovative technology backed by scientific research," said Dr. Mozzillo. "Use of the CHEMOSAT device will reinforce this commitment and will further support our position as a leader in cancer research and treatment."
"We are making significant progress in the European market through agreements with several leading institutions, including our latest partnership with the Istituto Nazionale Tumori Fondazione G. Pascale," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "G. Pascale is the sixth institution in an ever-growing network of CHEMOSAT centers in the EU. We plan to continue this momentum by entering into agreements with additional leading cancer centers in Europe in the coming months."
About the Istituto Nazionale Tumori Fondazione G. PascaleThe Istituto Nazionale Tumori Fondazione G. Pascale is the largest Scientific Institute for Research, Hospitalization and Health Care (IRCCS) in oncology in Southern Italy and is a center of reference for national and regional cancer programs. The Institute's mission is to achieve excellence in the field of oncology and the identification of new and appropriate guidelines on the prevention, diagnosis and treatment of cancer through clinical research and technological and management innovation. Founded in 1933, G. Pascale has over 850 members.
About Delcath SystemsDelcath Systems, Inc. is a 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 Istituto Nazionale Tumori Fondazione G. Pascale, patient outcomes from CHEMOSAT procedures, 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.Contact Information: Investor Contact:
Media Contact:Doug Sherk/Gregory Gin
Janine McCargoEVC Group
|SOURCE Delcath Systems, Inc.|
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