Contact Information: Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper (212) 838-1444
Delcath Expands Phase III Trial for Metastatic Melanoma to Include John Wayne Cancer Institute in California
| Source: Delcath Systems, Inc.
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.