SOURCE: Delcath Systems, Inc.

June 19, 2008 09:33 ET

Delcath Adds Atlantic Health to Phase III Trial for Metastatic Melanoma

Company Foresees Trial Completion in 2009

NEW YORK, NY--(Marketwire - June 19, 2008) - Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Atlantic Melanoma Center of Atlantic Health 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 for the isolated, high dose delivery of the anti-cancer agent melphalan. Atlantic Health is the fifth center in this multi-center study testing the Delcath System.

Delcath and Atlantic Health have entered into a clinical research agreement to join the National Cancer Institute (NCI) led study. Eric Whitman, MD, FACS, Director, Atlantic Melanoma Center and Medical Director, Office of Grants and Research, will serve as the Principal Investigator of the study. The PHP treatments will be performed at Morristown Memorial Hospital, in Morristown, New Jersey, part of Atlantic Health. Dr. Whitman brings many years of experience in melanoma and clinical research to this trial, and has been at the forefront of initiating new and promising technologies at his institution. On joining this trial, Dr. Whitman said, "I am very pleased to be able to enroll patients in this Phase III trial for metastatic melanoma, a disease for which an effective treatment has eluded us. Delcath's PHP System shows tremendous promise in its application to this indication, and I look forward to offering this new treatment to my patients."

Delcath Systems continues adding cancer centers to this Phase III trial, which has accrued one-third of the required ninety-two patients. On this recent expansion to include Atlantic Health, Richard Taney, President and CEO of Delcath, stated, "The Delcath System is now available at a number of leading cancer centers. Delcath continues working to reach its stated goals of expanding this Phase III trial and increasing physician awareness of the Delcath PHP System in order to improve the availability of this treatment to patients diagnosed with inoperable metastatic melanoma to the liver. We will continue to add centers to this trial, and hope to complete enrollment in 2009."

The Phase III Study

The Phase III study is designed to test Delcath's proprietary PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.

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. The Phase III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the US Food and Drug Administration (FDA) for commercial approval of the PHP System.

About Atlantic Health and Morristown Memorial Hospital

Atlantic Health (atlantichealth.org) is one of the largest non-profit health care systems in New Jersey and includes Overlook Hospital in Summit and Morristown Memorial Hospital. The two hospitals have a combined total of 1,133 licensed beds and more than 2,100 affiliated physicians providing a wide array of health care services to the five million residents of 11 Northern and Central New Jersey counties. Specialty services include cardiovascular care, neurosciences, pediatrics, cancer care, orthopedics, diabetes care, gastroenterology, trauma and emergency medicine, behavioral health, minimally invasive surgery, radiology and advanced diagnostics, women's health and maternal fetal medicine, home and hospice care and rehabilitation services. In 2008, Atlantic Health will complete the new Gagnon Heart Hospital, a 200,000 square-foot facility at Morristown Memorial that will consolidate Atlantic Health's cardiovascular services. The Gagnon Heart Hospital includes services at Morristown Memorial and Overlook hospitals.

Atlantic Health maintains a partnership with The Cancer Institute of New Jersey. Atlantic Health's hospitals are accredited by The Joint Commission. Atlantic Health is the primary academic and clinical affiliate in New Jersey of Mount Sinai School of Medicine and The Mount Sinai Hospital.

About Delcath Systems, Inc.

Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug melphalan in Phase III and Phase II clinical trials. The Company's intellectual property portfolio currently 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
    www.delcath.com

    Media Relations Contact:
    The Global Consulting Group
    Ivette Almeida
    ialmeida@hfgcg.com

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