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DELCATH EXPANDS PHASE III TRIAL
FOR METASTATIC MELANOMA TO INCLUDE UNIVERSITY OF MARYLAND MEDICAL CENTER
NEW YORK - April 25, 2008 - Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Institutional Review Board (IRB) of the University of Maryland Medical Center (UMMC) has approved UMMC's participation in the Phase III study of the Company's Percutaneous Hepatic Perfusion (PHP) System for the isolated, high dose delivery of the anti-cancer agent melphalan to treat inoperable metastatic melanoma in the liver. The pivotal, Phase III study is being led by the National Cancer Institute (NCI), which previously approved the study's expansion to a multi-center trial. UMMC has also entered into a clinical research agreement with Delcath enabling the hospital to immediately begin recruiting and treating patients. H. Richard Alexander, M.D., Professor of Surgery and Associate Chairman for Clinical Research, Surgery at the University of Maryland will serve as Principal Investigator of the study at this new center. Dr. Alexander, a recognized leader in the field of regional cancer therapy, was previously Deputy Director of the NCI's Center for Cancer Research, and Principal Investigator of the Phase I study that was Fast Tracked to this current Phase III study. "The diagnosis of liver metastases results in a very poor prognosis for the patient," commented Dr. Alexander. "The Delcath System may represent an effective, minimally toxic means of restoring liver health and improving patient outcome. UMMC is committed to remaining at the forefront of cancer research and treatment. We look forward to participating in this NCI-led pivotal study and to understanding how this system may benefit patients." "Expanding this Phase III study to premier oncology centers such
as UMMC remains a top priority for the Company, as it allows the Delcath
System to reach more patients desperately in need of new treatment options
and expands physician awareness of its potential clinical benefit,"
said Richard L. Taney, President and CEO of Delcath Systems. "It
is especially exciting to be collaborating with Dr. Alexander, who pioneered
the use of our PHP system with Melphalan while at the NCI. Throughout
2008, we expect to expand the study to additional clinical sites with
world-class clinical oncology programs. Several of these sites are currently
in the process of securing the necessary approvals in order to join our
clinical trials." Patients in the Phase III trial initially are randomized into one of
two treatment arms, including immediate treatment with melphalan via the
Delcath System or treatment with best alternative care. The study is designed
to evaluate the duration of tumor response in each of the two study arms.
Following guidelines established by U.S. Food and Drug Administration
(FDA) under a Special Protocol Assessment (SPA), when disease progresses
in patients enrolled in the best alternative care arm of the trial, they
are permitted to "cross over" and receive treatment with the
Delcath System. About University of Maryland Medical Center About Delcath Systems, Inc. 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 our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system 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.
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