NEW YORK, Jan. 11, 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 a
review of the Delcath Hepatic Delivery System (Melphalan/HDS) for
the treatment of patients with liver cancers has been published in
Cardiovascular & Interventional Radiology (CVIR), a
leading peer-reviewed medical journal.
The review is entitled, "Percutaneous Isolated Hepatic
Perfusion for the Treatment of Unresectable Liver
Malignancies," by Dr. Mark C.
Burgmans, et al. from Leiden University Medical Center
(LUMC), in the Netherlands, and
includes the first published overview of the enhanced version of
the Melphalan/HDS device and procedure. This version of the
Melphalan/HDS device and procedure has been used commercially in
Europe since 2012 and is being
used in the current trials that comprise the Company's clinical
development plan. In their update of current literature on
percutaneous hepatic perfusion, the LUMC team noted that the
current version of the Delcath product and procedure "appear to
have reduced the rate and severity of bone marrow suppression" over
the previous version of the system. The authors concluded that
treatment with Melphalan/HDS "holds promise as a locoregional
therapy for patients with hepatic malignancies" and "is a novel,
minimally invasive and repeatable alternative for isolated hepatic
perfusion."
"The review provides a useful overview of the refinements to
both our product and procedure that have been made since the 2010
completion of our prior U.S. Phase 3 trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President
and Chief Executive Officer of Delcath. "We look forward to
initiating our new Global Phase 3 trial in hepatic dominant ocular
melanoma, and are confident that the improvements in the reduction
of toxicities noted by the LUMC team can be formally validated in
this pivotal study. We look forward to working further with LUMC
and others to realize the potential identified in this 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
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: 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.