Delcath Adds Providence Cancer Center To Phase III Trial - Robert W. Franz Cancer Research Center Is 2nd West Coast Center

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials;  Melanoma / Skin Cancer
Article Date: 25 Sep 2008 - 5:00 PDT

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Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Robert W. Franz Cancer Research Center, a part of the Providence Cancer Center, located in Portland, Oregon, has joined Delcath's Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Company's Percutaneous Hepatic Perfusion (PHP) System. This pivotal multi-center study for the isolated, high dose delivery of the anti-cancer agent melphalan is led by the National Cancer Institute (NCI). Providence, the tenth center to join this trial, will be able to provide this treatment option to a previously unreached patient population in the Pacific Northwest region of the United States. Delcath's Phase III study has recently expanded throughout the U.S., and is now enrolling at the following institutions:

-- National Cancer Institute in Bethesda, Maryland
-- Albany Medical Center in Albany, New York
-- John Wayne Cancer Center in Santa Monica, California
-- Moffitt Cancer Center in Tampa, Florida
-- Morristown Memorial Hospital in Morristown, New Jersey
-- Providence Cancer Center in Portland, Oregon
-- St. Luke's Cancer Center of Bethlehem, Pennsylvania
-- Swedish Medical Center in Englewood, Colorado
-- University of Maryland Medical Center in Baltimore, Maryland
-- University of Texas Medical Branch in Galveston, Texas

Delcath is announcing the expansion of this trial following Providence entering into a clinical research agreement with Delcath. Walter J. Urba, M.D., Ph.D., Medical Director of the Robert W. Franz Cancer Research Center and Earle A. Chiles Research Institute -- a part of the Providence Cancer Center -- will serve as the Principal Investigator of the study. Commenting on joining this Phase III study, Dr. Urba stated, "Providence is excited and motivated to be joining this promising trial. Melanoma metastasized to the liver leaves patients with few options, and Providence Cancer Center is eager to offer this treatment modality to our patients. Regional therapy has shown impressive results for unresectable cancer of the liver, and targeting the liver with high doses of drug focuses this technique towards the most pressing and life-limiting organ. We look forward to joining the other leading cancer centers involved with this trial to bring these patients a much needed treatment option."

"The addition of Providence Cancer Center to this trial further propels Delcath towards its goal of completing enrollment in 2009," commented Richard L. Taney, President and CEO of Delcath. "For decades, Dr. Urba has been a leader in the research and implementation of melanoma treatments and he brings to this trial significant clinical and academic experience. Patients suffering from this devastating disease now have a number of leading cancer centers throughout the United States to turn to for this treatment modality and we look forward to continuing this progress."

About Providence Cancer Center

Providence Cancer Center serves more cancer patients than any other health system in Oregon. Here, patients and families benefit from some of the finest, most comprehensive cancer services in the world, including the best in diagnostic imaging, state-of-the-art treatments, nationally renowned research, and compassionate counseling and support. Our doctors, nurses, researchers, patient advocates and other caregivers work together to treat cancer aggressively and to ensure that no person has to face the challenge of a cancer diagnosis alone.

About Delcath Systems, Inc.

Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company has developed a proprietary, patented system which will improve the efficacy of cancer treatment while reducing the considerable, systemic side-effects of chemotherapy. Delcath's novel drug delivery platform is capable of delivering anti-cancer drugs at very high doses to a specific organ or region of the body while preventing these high doses of drug from entering the patient's bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company's intellectual property portfolio consists of twenty-eight patents on a worldwide basis including the U.S., Europe, Asia and Canada. 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 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.

Delcath Systems, Inc.