NEW YORK, June 1, 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
the General and Digestive Surgery team at HM Sanchinarro University
Hospital, led by Emilio Vicente,
M.D. and Yolanda Quijano, M.D., has
successfully launched the hospital's Hepatic Chemosaturation
Program. The Sanchinarro team successfully performed three
procedures with Delcath's proprietary Melphalan Hydrochloride for
Injection for use with the Delcath Hepatic Delivery System
(CHEMOSAT® or Melphalan/HDS). The team at HM Sanchinarro
is using the CHEMOSAT procedure in peripheral cholangiocarcinoma,
neuroendocrine tumours and colorectal liver metastases. HM
Sanchinarro University Hospital is the second center in
Spain to offer the treatment.
"This is an exciting approach for the treatment of liver
tumors," said Drs. Vicente and Quijano. "We believe that the
administration of high-dose melphalan directly to the liver has
great promise in the treatment of a variety of tumor types, and the
associated side effects are also minimized and more manageable. In
recent years, the successful development of this percutaneous
procedure has been a breakthrough, as it significantly reduces the
technique's morbidity rate. We are very excited about adopting this
new procedure at HM Sanchinarro University Hospital."
Jennifer K. Simpson, Ph.D., MSN,
CRNP, President and CEO of Delcath Systems Inc., said, "We are
extremely pleased that the HM Sanchinarro Hospital has commenced
its Chemosaturation Program with our CHEMOSAT Delivery System. HM
Sanchinarro is one of the leading cancer centers in Spain, both in terms of treatment and
research. This underscores how CHEMOSAT continues to be
increasingly accepted as an effective therapy for patients with
liver metastasis who would otherwise have few, if any, treatment
options."
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 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 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.