Delcath Announces Medical University of Hannover in Germany Celebrates 100th CHEMOSAT Treatment
29 August 2017 - 11:30AM
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver
cancers, congratulates the team at the Medical University of
Hannover Hospital on their performance of the hospital’s 100th
percutaneous hepatic perfusion (PHP®) procedure with CHEMOSAT®. The
Hannover team, led by Professor Dr. Frank Wacker, Director of the
Institute for Diagnostic and Interventional Radiology and Professor
Dr. Michael Manns, Director of the Department of Gastroenterology,
Hepatology and Endocrinology, celebrated the institution’s
achievement at a ceremony at the Hospital on August 18, 2017.
PHP with Melphalan/HDS was developed by Delcath
Systems as a targeted, whole organ therapy for the liver. The
product is commercially available in Europe under the trade name
CHEMOSAT, and is being evaluated as an investigational therapy in
the U.S. Delcath is currently enrolling patients in the FOCUS
trial, a global Phase 3 clinical trial that is investigating PHP
with Melphalan/HDS as a treatment for patients with ocular melanoma
that has metastasized to the liver, and has plans to begin
enrollment in a Registration trial for intrahepatic
cholangiocarcinoma (ICC) in 2017.
PHP is a minimally invasive procedure that
isolates the liver from the body’s circulatory system, so that a
high dose of chemotherapy (melphalan hydrochloride) may be infused
directly into the liver with the potential to treat both visualized
and non-visualized metastases. Blood from the liver is then
filtered to remove the chemotherapeutic agent thereby minimizing
systemic exposure and potentially the associated side effects.
About Medical University of
HannoverThe Medical University of Hannover was founded in
1965, and is a leading university medical center research in
Germany. The University has an outstanding reputation in
interdisciplinary collaboration both within the MHH and with
extramural scientific institutions, and is the German medical
university with the greatest volume of grant funding.
About Delcath SystemsDelcath
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 plans to initiate a
Registration trial for intrahepatic cholangiocarcinoma (ICC) by the
end of 2017 contingent on effecting the reverse stock split as
outlined in the Company’s consent proposal. 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.
Forward Looking Statements:
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 and ICC clinical trial
programs, timely enrollment and treatment of patients in the
global Phase 3 OM clinical trial, IRB or ethics committee clearance
of the Phase 3 OM and ICC Registration trial 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,, 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:
Contact:
Scott Gordon
President - CoreIR
Email: investorrelations@delcath.com