NEW YORK, Feb. 10, 2016 /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
patient enrollment has begun in the Company's Phase 3 clinical
trial: "A Randomized, Controlled, Phase 3 Study to
Evaluate the Efficacy, Safety, and Pharmacokinetics of
Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular
Melanoma" (the FOCUS Trial). The first patient was evaluated
and randomized into the trial at the Moffitt Cancer Center in
Tampa, Florida.
The FOCUS Trial is evaluating the efficacy, safety and
pharmacokinetics of Melphalan/HDS versus best alternative care in
240 patients with ocular melanoma (OM). The primary objective of
the study is a comparison of overall survival between the
Melphalan/HDS treatment arm and best alternative care comprised of
selected therapies; secondary objectives include overall
progression-free survival and objective response rate, each as
determined by the Investigator, while exploratory objectives
include progression-free survival, objective response rate, hepatic
progression free survival and hepatic objective response rate all
as determined by Independent Central Review, and quality of life
measures. The FOCUS Trial is being conducted under a Special
Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA) to support marketing approval in the U.S.
"Our team at Moffitt Cancer Center is very excited to begin this
trial and is looking forward to verifying the potential
for Melphalan/HDS in this life-threatening cancer with no
effective treatment options," said Jonathan
Zager, M.D., FACS, Professor of Surgery in the Cutaneous
Oncology and Sarcoma Departments and a Senior Member at Moffitt
Cancer Center, and the FOCUS Trial's principal investigator.
"Given the high unmet medical need in hepatic dominant ocular
melanoma, it is not surprising to see enrollment in our FOCUS Trial
begin quickly," said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath.
"Interest in the FOCUS Trial has been strong among other major
cancer centers, and we expect to announce additional trial sites
globally in the near term."
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, 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, 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
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 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.
Contact Information:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.