Contact Information: Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 www.delcath.com Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper (212) 838-1444
Delcath Expands Phase III Trial for Metastatic Melanoma to Florida
Moffitt Cancer Center Joins Trial Treating Inoperable Cancers
| Source: Delcath Systems, Inc.
NEW YORK, NY--(Marketwire - July 24, 2008) - Delcath Systems, Inc. (NASDAQ : DCTH ) announced
today that Moffitt Cancer Center ("Moffitt"), a National Cancer Institute
Comprehensive Cancer Center, 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. Moffitt is the
seventh center in this multi-center trial using the Delcath System.
Delcath and Moffitt have entered into a clinical research agreement to
conduct the Phase III National Cancer Institute (NCI) led study. Jonathan
S. Zager, MD, Assistant Professor of Surgery in the Department of Oncologic
Sciences and a member of the Division of Cutaneous Oncology at Moffitt will
serve as the Principal Investigator of the study. On joining this study,
Dr. Zager commented, "This is a tremendous opportunity for Moffitt and our
patients to be able to enroll in this trial. Metastatic melanoma is a
devastating disease, providing limited treatment options and resistant
against most therapies. This trial provides hope and promise to patients
suffering from this disease and we look forward to being able to assist in
the enrollment process and bettering our patients' prognoses."
Commenting on Moffitt joining this trial, Richard L. Taney, President and
CEO of Delcath, stated, "Our expansion of this trial continues and we are
very excited to be able to enroll patients at Moffitt under the leadership
of Dr. Zager, who brings broad experience in melanoma and clinical research
to this study. By working with leading melanoma physicians and centers,
such as Dr. Zager and Moffitt, we are increasing the availability of this
treatment option to more geographic regions and patients. We will continue
our efforts to broaden the reach of this trial through the addition of
recognized cancer centers, make this treatment option available to as many
patients as possible, and to reach our goal of completing trial 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 H. Lee Moffitt Cancer Center & Research Institute
Located in Tampa, Florida, Moffitt Cancer Center is the only Florida-based
cancer center with the NCI designation as a Comprehensive Cancer Center for
its excellence in research and contributions to clinical trials, prevention
and cancer control. Moffitt currently has 15 affiliates in Florida, one in
Georgia and two in Puerto Rico. Additionally, Moffitt is a member of
the National Comprehensive Cancer Network, a prestigious alliance of the
country's leading cancer centers, and is listed in U.S. News & World Report
as one of "America's Best Hospitals" for cancer, as well as for ear, nose
and throat. Moffitt's sole mission is to contribute to the prevention and
cure of cancer.
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
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