NEW YORK, Oct. 17, 2016 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), an interventional oncology Company focused on
the treatment of primary and metastatic liver cancers, announces
that a review of research conducted with the Delcath Hepatic
CHEMOSAT® Delivery System (CHEMOSAT) has been accepted for
publication by the prestigious medical journal, Advances in
Therapy. The retrospective study, "Chemosaturation
Percutaneous Hepatic Perfusion: A Systemic Review," was
conducted by a team led by Dr. Arndt
Vogel of the University of Hanover in Germany, and resulted from a CHEMOSAT Experts
Forum convened by Delcath in February
2015.
"This retrospective study originated as a white paper produced
by our Experts Panel in 2015 as a means of sharing information,
recent research results, and clinical experiences using CHEMOSAT to
treat primary and metastatic liver cancers," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President
and Chief Executive Officer of Delcath. "We are pleased that Dr.
Vogel and his teams' work has been accepted for publication in such
a prestigious journal as Advances in Therapy, and that the
potential for CHEMOSAT to treat primary and metastatic liver
cancers as identified by our experts will reach a wider
audience."
About Delcath Systems
Delcath Systems, Inc. is an
interventional oncology Company focused on the treatment of primary
and metastatic liver cancers. Our investigational product—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 and associated side effects. We have commenced a 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). Melphalan/HDS has not been
approved by the U.S. Food & Drug Administration (FDA) for sale
in the U.S. In Europe, our system has been commercially
available since 2012 under the trade name Delcath Hepatic
CHEMOSAT® Delivery System for Melphalan (CHEMOSAT),
where it has been used at major medical centers to treat a wide
range of cancers of 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: our ability
to repay and comply with the obligations under our senior secured
convertible notes, 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, 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 CHEMOSAT/Melphalan HDS system and the potential
of the CHEMOSAT/Melphalan HDS 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 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.