NEW YORK, July 18, 2016 /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
abstracts from two studies conducted in Germany of use of the Delcath Hepatic
CHEMOSAT® Delivery System to treat patients with liver
metastases, have been accepted for presentation as posters at the
Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting. The abstracts
are:
Percutaneous Isolated Hepatic
Perfusion (Chemosaturation) In Patients With Primary Or Secondary
Liver Tumours: Experience In 20 Patients, by S. Marquardt, et
al, of Hanover Medical School in Hanover,
Germany.
Secondary Resectability Of
Ocular Melanoma Liver Metastases Following Percutaneous Hepatic
Perfusion by M. Zeile, and A. Stang, et al of the Asklepios
Barmbek Clinic in Hamburg,
Germany.
The CIRSE conference will be held in Barcelona, Spain at the Centre de Convencions
Internacional de Barcelona from
September 10-14, 2016. Additional
information for the CIRSE Scientific Program is available here.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and
medical device company focused on oncology with a principal focus
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).
Melphalan/HDS has not been approved for sale in the U.S. We have
commenced our global Phase 3 FOCUS clinical trial for Patients with
Hepatic Dominant Ocular Melanoma (OM) and 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).
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: the timing and results
of the Company's clinical trials including without limitation
the OM, HCC ,and ICC clinical trial programs, timely
enrollment and treatment of patients in the global Phase 3 FOCUS
Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma
and the global Phase 2 HCC and ICC clinical trials, 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,
if any, of publication of the Phase 3 trial manuscript to support
the Company's efforts, the impact of the presentations at
major medical conferences 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
ZE reimbursement 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, 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 remaining 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.
Investor Contact:
Anne Marie
Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.