NEW YORK, Oct. 12, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company
focused on the treatment of primary and metastatic liver cancers,
announces that five clinical sites in Europe have been activated and are open for
patient enrollment in the Company's FOCUS Phase 3 clinical trial
for patients with hepatic dominant ocular melanoma (the FOCUS
Trial). The sites are the first centers in Europe to begin enrolling patients in the
FOCUS Trial. One center, Charité University Hospital in
Berlin, Germany, has treated its
first patient. Delcath now has 13 centers in the U.S. and
Europe open for patient
recruitment, and expects up to 30 centers will participate in the
FOCUS Trial.
The following highly-accredited European centers are now open
for patient enrollment:
Austria
- University Hospital, Graz
Germany
- Charité University Hospital, Berlin
- University Hospital, Marburg
- University Hospital, Regensburg
United Kingdom
- University Hospital Southampton
"We are pleased to add these highly respected European cancer
centers to our FOCUS Trial," said Jennifer
K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath.
"This expansion allows Delcath to work with the some of
Europe's top universities and
institutes while providing some of Europe's leading clinicians with first-hand
knowledge of our therapy, which will continue to be of great value
as we expand our commercial footprint for CHEMOSAT as a treatment
for ocular melanoma in Europe."
About the FOCUS Trial
The FOCUS Trial is a global Phase 3 clinical study evaluating
the safety, efficacy and pharmacokinetic profile of the Company's
Melphalan/HDS system versus best alternative care in 240 patients
with ocular melanoma liver metastases. The FOCUS Trial's primary
endpoint is a comparison of overall survival between the two study
arms; secondary and exploratory endpoints include progression-free
survival, overall response rate and quality-of-life measures. The
FOCUS Trial is being conducted under a Special Protocol Assessment
(SPA) with the U.S. Food and Drug Administration (FDA). The SPA
provides agreement that the Phase 3 trial design adequately
addresses objectives that, if met, would support the submission for
regulatory approval of Melphalan/HDS.
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:
Anne
Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.