NEW YORK, Sept. 12, 2016 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), an interventional oncology Company focused on
the treatment of primary and metastatic liver cancers, announces
that a research team led by Dr. Mark C.
Burgmans at Leiden University Medical Center (LUMC) in
the Netherlands has received the
prestigious Outstanding Service Award from Cardiovascular
& Interventional Radiology (CVIR), a leading peer-reviewed
medical journal. The LUMC team were recognized for their review of
the Delcath Hepatic Delivery System (Melphalan/HDS), entitled,
"Percutaneous Isolated Hepatic Perfusion for the Treatment of
Unresectable Liver Malignancies," which was published by
CVIR in January 2016. The award was
presented to Dr. Burgmans and his team at a ceremony during the
Cardiovascular & Interventional Radiology Society of
Europe (CIRSE) annual
conference, held in Barcelona,
Spain, September 10-14,
2016.
The LUMC's research review was the first published overview of
the current version of the Melphalan/HDS device and procedure,
which includes upgrade filters and further developed procedural
techniques. 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."
"We are very pleased to see the team at LUMC recognized for
their contribution to the growing body of research into the
potential of Melphalan/HDS for patients with cancers of the liver,"
said Jennifer K. Simpson, Ph.D.,
MSN, CRNP, President and Chief Executive Officer of Delcath.
"Research presented or published since this review was conducted
have added support to the LUMC teams' conclusions, and we are
confident that the improvements in the reduction of toxicities and
the overall potential noted by the LUMC team can be formally
validated in trials that comprise our clinical development plan. 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 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/researchers-at-leiden-univeristy-medical-center-receive-outstanding-service-award-for-publication-on-delcaths-melphalanhds-300326026.html
SOURCE Delcath Systems, Inc.