NEW YORK, Dec. 2, 2015 /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 physicians in
Europe have completed over 250
treatments with Delcath Hepatic CHEMOSAT® Delivery System
(CHEMOSAT) since the second generation of CHEMOSAT was launched.
Physicians in Europe have used
CHEMOSAT in both commercial and clinical settings to treat patients
for a wide variety of cancers in the liver, including ocular
melanoma liver metastases, hepatocellular carcinoma and
intrahepatic cholangiocarcinoma, and liver metastases from
colorectal cancer, breast cancer and others.
Concurrently, Delcath announces the activation of the
prestigious Harley Street Clinic (HSC) in London, United Kingdom as a CHEMOSAT treatment
site. HSC is a specialist private hospital that provides
complex cardiac, cancer and neurosciences care. HSC is supported by
HCA International and owned by HCA Inc., the largest provider of
private healthcare in the world. Julian
Hague, M.D., an interventional radiologist with HSC,
performed the clinic's first CHEMOSAT treatment on a patient with
breast cancer liver metastases in November.
"I believe the future of interventional oncology lies in
tailoring the treatment to the individual patient," said Dr. Hague.
"I believe having CHEMOSAT in our treatment armamentarium
represents major progress in our ability to provide liver directed
therapies to patients."
"The completion of our 250th CHEMOSAT treatment and
the activation of the Harley Street Clinic highlight the steady
progress our team has made in expanding the clinical adoption of
this therapy," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and Chief Executive
Officer of Delcath Systems. "Over the past two years our team has
built a strong commercial and clinical footprint for CHEMOSAT in
Europe. We look forward to
continuing to build on this momentum in the New Year in order to
increase revenue and, importantly, to enhance the lives of patients
suffering with these life-limiting conditions."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology with an emphasis 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). The Melphalan/HDS system
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:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.