NEW YORK, Sept. 9, 2015 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device
company focused on oncology with an emphasis on the treatment of
primary and metastatic liver cancers, announces that an abstract
summarizing data from a multi-center European experience of
treatments with the Delcath Hepatic CHEMOSAT®
Delivery System (CHEMOSAT) will be presented at the upcoming
Radiological Society of North
America (RSNA) 100th Scientific Assembly and Annual Meeting,
which will be held in Chicago from
November 29-December 4, 2015.
The abstract is:
Chemosaturation with
Percutaneous Hepatic Perfusion of Melphalan for Hepatic Metastases
from Uveal Melanoma: Multi-institutional Evaluation,
T. J. Vogl, S. A. Koch, B. Gebauer, W. Willinek, C. Engelke,
R. Bruning, A. Enk
Additional details for the RSNA scientific program can be found
here.
About Delcath Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology with an emphasis on the treatment of primary and
metastatic liver cancers. Our proprietary Melphalan Hydrochloride
for Injection for use with the Delcath Hepatic Delivery System
(Melphalan/HDS) is designed to administer high-dose chemotherapy to
the liver while controlling systemic exposure. In April 2012 we obtained authorization to affix a
CE Mark to our second-generation system, which is currently
marketed in Europe as a device
under the trade name Delcath Hepatic CHEMOSAT® Delivery System for
Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is
considered a combination drug and device product, and is regulated
as a drug by the U.S. Food and Drug Administration (FDA). The
Melphalan/HDS system has not been approved for sale in the U.S. We
have commenced a global Phase 2 clinical trial in Europe and the U.S. to investigate the
Melphalan/HDS system for the treatment of primary liver cancer
(HCC) and intrahepatic cholangiocarcinoma (ICC), and expect to
initiate a global Phase 3 trial in ocular melanoma (OM) that has
metastasized to the liver.
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: future patient outcomes
and clinical trial results consistent with the data contained in
the SSO abstract, acceptance and publication of the Phase 3 trial
manuscript and the impact of publication to support the Company's
efforts, the timing and results of the Company's
clinical trials including without limitation the HCC, ICC and
OM clinical trial programs timely enrollment and
treatment of patients in the global Phase 2 HCC and ICC clinical
trial, FDA approval of the global Phase 3 OM clinical trial
protocol, IRB or ethics committee clearance of the Phase 2
HCC/ICC and/or Phase 3 OM protocols from
participating sites and the timing of site activation and subject
enrollment in each trial, the impact of the presentations at ESSO
and future clinical results consistent with the data presented,
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure, the impact, if any of Value 4 status on
potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe including the
key markets of Germany and the UK,
the Company's ability to successfully commercialize the Melphalan
HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT
system as a treatment for patients with primary and metastatic
disease in the liver, our ability to obtain reimbursement for the
CHEMOSAT system in various markets, the Company's ability to
satisfy the requirements of the FDA's Complete Response Letter and
provide the same in a timely manner, approval of the current or
future Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets, actions by the FDA or other
foreign regulatory agencies, the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same,
uncertainties relating to the timing and results of research and
development projects, our ability to maintain NASDAQ listing, and
uncertainties regarding the Company's ability to obtain financial
and other resources for any research, development, clinical trials
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:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.