Delcath Adds Atlantic Health to Phase III Trial for Metastatic Melanoma

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Thu Jun 19, 2008 9:34am EDT

  NEW YORK, NY, Jun 19 (MARKET WIRE) -- 
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.

    

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

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