SOURCE: Delcath Systems, Inc.

August 12, 2008 08:30 ET

Delcath Expands Phase III Trial for Metastatic Melanoma to Include John Wayne Cancer Institute in California

NEW YORK, NY--(Marketwire - August 12, 2008) - Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the John Wayne Cancer Institute ("JWCI"), at Saint John's Health Center in Santa Monica, California, has joined Delcath's Phase III clinical trial for the treatment of metastatic melanoma in the liver. JWCI is the eighth center in this multi-center trial testing the Company's Percutaneous Hepatic Perfusion (PHP) System for the isolated, high-dose delivery of the anti-cancer agent melphalan.

Delcath and JWCI have entered into a clinical research agreement to conduct the Phase III National Cancer Institute (NCI) led study. Mark Faries, M.D., Director, Translational Tumor Immunology at JWCI, will serve as the Principal Investigator of the study. Dr. Faries commented, "Delcath's technology is a much needed advancement for the treatment of unresectable melanomas in the liver. There has been a large body of research supporting the targeted high-dose delivery of melphalan for these cancers, and PHP holds tremendous promise for the treatment of melanoma as well as other cancers in the liver. I am very excited to be enrolling patients in this trial, and providing them with a much needed therapy for a disease that offers limited options."

On JWCI joining this trial, Richard L. Taney, President and CEO of Delcath, stated, "We are delighted to be working with Dr. Faries and JWCI, and to be able to provide this treatment modality to patients on the West Coast of the United States. JWCI's and Dr. Faries' reputation and commitment to cutting-edge cancer treatment and their focus on melanoma make this an ideal site to be part of this trial. The Company will build on the momentum that the new sites bring to this trial, and we anticipate completion of enrollment in 2009."

About John Wayne Cancer Institute

Since 1981, the John Wayne name has been committed by the Wayne Family to leading-edge cancer research and education, in memory of their father who died of stomach cancer in 1979. The Institute, previously known as the John Wayne Cancer Clinic at UCLA, was formed by the Wayne Foundation and headed by eldest son Michael. Over the next decade, Michael Wayne served as Chairman of the Board -- a position he held until his death in 2003. Patrick Wayne, Michael's brother, now serves as Chairman of the Board and provides continued determination toward the family's goal of curing this dreaded disease.

In 1991, the John Wayne Cancer Institute (JWCI) launched a successful affiliation with Saint John's Health Center and opened in Santa Monica, California. Combined with the exceptional quality of Saint John's medical staff and hospital, a unique cancer institute was created, outstanding in the areas of translational research, and the treatment of solid tumors including surgical oncology, immunotherapy, chemotherapy, and radiation.

Today, the tradition of excellence continues as JWCI spearheads new research advances while training the next generation of surgical oncologists. The Institute conducts multidisciplinary basic, clinical translational research on many complex cancer problems, focusing in particular on melanoma, breast cancer, prostate cancer, colon cancer, and sarcoma.

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 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.

Contact Information

  • Company Contact:
    Delcath Systems, Inc.
    Richard Taney
    (212) 489-2100
    Email Contact

    Investor Relations Contact:
    Strategic Growth International, Inc.
    Richard E. Cooper
    (212) 838-1444
    Email Contact