NEW YORK, May 3, 2016 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device
company focused on the treatment of primary and metastatic liver
cancers, announces that John Wayne Cancer Institute in Los Angeles, California and Duke Cancer
Institute in Durham, North
Carolina have been activated as clinical trial sites in the
Company's FOCUS Phase 3 Clinical Trial for Patients with Hepatic
Dominant Ocular Melanoma (the FOCUS Trial). The
prestigious centers join Moffitt Cancer Center in Tampa, Florida as active participants in the
FOCUS Trial. Delcath plans to include approximately 30 cancer
centers in the United States and
Europe in the FOCUS Trial.
"We are pleased to add these highly-respected cancer centers to
our FOCUS Phase 3 trial," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath
Systems. "Interest in participating in the FOCUS trial is high
among other major cancer centers in both the United States and Europe, and we expect to announce further
trial site activations in the coming months."
About the FOCUS Trial
The FOCUS Trial is 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 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 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 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.