Spire Southampton Hospital in UK Celebrating Over 100 CHEMOSAT Treatments
April 18 2017 - 8:00AM
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver
cancers, commended Spire Southampton Hospital on the performance of
over 100 percutaneous hepatic perfusion (PHP®) procedures with
CHEMOSAT®. 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.
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.
As part of the Spire Southampton’s celebration
of this milestone, a hospital statement highlighted the case of
Brian Carney, a retired businessman from Leeds, UK. Mr.
Carney was initially diagnosed with ocular melanoma in 2005, and in
2013 physicians discovered the disease had metastasized to his
liver. Prognosis after ocular melanoma has metastasized in
the liver is poor with a median survival of six months. In the case
of Mr. Carney, he was referred to Spire Southampton, and received
his first PHP treatment in December 2013. In the intervening
period, he has also undergone liver resections and immunotherapy
treatments. He recently became the first patient in the world
to receive eight PHP treatments, which controlled the tumor and
allowed him to conduct normal daily activities at his home. Mr.
Carney remains under the care of Spire Southampton where his
condition is regularly checked between therapies.
About Spire SouthamptonSpire
Southampton Hospital is a leading independent hospital group in the
United Kingdom with 38 hospitals and 12 clinics across England,
Wales and Scotland. The hospital is a leading CHEMOSAT-treatment
center, performing the highest number of recorded PHP treatments in
the world.
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 plan to initiate a
Registration trial for intrahepatic cholangiocarcinoma (ICC) in the
Fall of 2017. 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:
David Boral
Managing Director
CoreIR
Tel: 516 222 2560
Email: davidb@coreir.com