NEW YORK, Dec. 8, 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 a
review study of treatment of liver cancers with the Delcath Hepatic
CHEMOSAT® Delivery System (Melphalan/HDS) has
been accepted for publication in the Cardiovascular and
Interventional Radiology (CVIR), a leading peer-reviewed
medical journal.
The manuscript entitled "Percutaneous Isolated Hepatic
Perfusion for the Treatment of Unresectable Liver Malignancies"
was prepared and submitted by lead author Mark C. Burgmans, M.D., Department of Radiology,
Leiden University Medical Centre (LUMC) in Leiden, the Netherlands. The manuscript reviews the
development history, procedure and initial clinical results
achieved with CHEMOSAT in a variety of hepatic malignancies.
"We have been working with percutaneous hepatic perfusion and
CHEMOSAT since 2014 and our own experience confirms the main
conclusion of this review, that PHP with CHEMOSAT is a promising
new treatment for a variety of liver malignancies," said Dr.
Burgmans.
"This review is the latest in a series of data presentations and
publications supporting CHEMOSAT that have recently been presented
or published," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and Chief Executive
Officer of Delcath. "Interest in CHEMOSAT among researchers
in Europe continues to grow, and
we look forward to working with the team at LUMC to validate the
potential identified in their review."
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 a global Phase 2 clinical trial in
Europe and the U.S. to investigate
Melphalan/HDS for the treatment of primary liver cancer (HCC), and
expect to initiate a global Phase 3 trial in ocular melanoma (OM)
that has metastasized to the liver and plan to evaluate
intrahepatic cholangiocarcinoma (ICC) in a Phase 2 clinical
study.
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 impact, if any, of
publication of the Phase 3 trial manuscript 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 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
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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.