Contact Information: Company Contact: Delcath Systems, Inc. Richard Taney (212) 489-2100 www.delcath.com Media Relations Contact: The Global Consulting Group Ivette Almeida Investor Relations Contact: Strategic Growth International, Inc. Richard E. Cooper (212) 838-1444
Delcath Expands Multi-Center Phase III Trial for Metastatic Melanoma
University of Texas Medical Branch Extends Geographic Penetration
| Source: Delcath Systems, Inc.
NEW YORK, NY--(Marketwire - June 24, 2008) - Delcath Systems, Inc. (NASDAQ : DCTH ) announced
today that the University of Texas Medical Branch at Galveston (UTMB), part
of the University of Texas System, 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. UTMB is
the sixth center in this multi-center study testing the Delcath System.
Delcath and UTMB have entered into a clinical research agreement to conduct
the Phase III National Cancer Institute (NCI) led study. Orhan S. Ozkan,
MD, Associate Professor of Radiology and Director of Vascular and
Interventional Radiology, will serve as the Principal Investigator of the
study. On joining this study, Dr. Ozkan commented, "We are excited about
being a part of this clinical trial and being the first center to offer
this treatment modality to patients in this region of the US. This
treatment offers tremendous promise for patients suffering from metastatic
melanoma in the liver, and we are pleased to be able to offer this option
to our patients."
Over the past two months, Delcath Systems has added five cancer centers to
this Phase III trial, which needs fewer than sixty additional patients to
reach full enrollment. On the addition of UTMB to this study, Richard
Taney, President and CEO of Delcath, stated, "We continue our efforts to
make this treatment option available at leading cancer centers throughout
the United States. Dr. Ozkan's participation will provide patients in the
southwest region of the country access to this trial and provides an
important treatment option for inoperable metastatic melanoma to the liver.
The interest in PHP by the physicians treating this fatal condition
continues to grow and we continue working to expand the geographic
availability of our technology."
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 the University of Texas Medical Branch at Galveston
UTMB is a major academic health center dedicated to improving lives through
health sciences education, clinical care and biomedical research. The
University has six hospitals in Galveston, 90 campus- and community-based
clinics, and four schools: medical, nursing, allied health sciences, and a
graduate school for biomedical sciences. UTMB is the lead institution for
the Western Regional Center of Excellence for Biodefense and Emerging
Infectious Diseases and is the site of the Galveston National Laboratory,
one of only two national biocontainment laboratories. Last year UTMB had
$156 million in research expenditures with $105 million in NIH funding.
Major research and patient care initiatives include a cancer center, a
transplant center, molecular cardiology, burns care, neurology and the
neurosciences, infectious disease, and women's and children's health. The
University is the seventh largest employer among those headquartered in the
Houston/Galveston region with 12,000 employees and a $1.4 billion budget.
For more information, please visit the UTMB website at http://www.utmb.edu/
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.