NEW YORK, Jan. 18, 2017 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company
focused on the treatment of primary and metastatic liver cancers,
today announced that new data from a retrospective study of
Melphalan/HDS, entitled "Percutaneous Hepatic Perfusion For
Unresectable Metastatic Ocular Melanoma To The Liver: A
Multi-Institutional Report Of Outcomes," has been accepted for
oral presentation at the Regional Cancer Therapies 12th
International Symposium, taking place February 18 - 20, 2017 at the Snowbird Ski and
Summer Resort in Snowbird, UT.
The retrospective study was conducted by teams from Moffitt
Cancer Center in Tampa, FL and the
University of Southampton in the United
Kingdom. The study explores patient treatment outcomes with
Percutaneous Hepatic Perfusion (PHP® Therapy) with
Melphalan/HDS in patients with primary metastatic ocular melanoma
(OM) with liver metastasis treated between 2008 and 2016. The study
was led by Dr. Alexandra Gangi of
the Moffitt Cancer Center.
"We are very pleased that Dr. Gangi and her team's research has
been accepted for oral presentation at this prestigious event and
believe that their research results will further inform on the use
of Melphalan/HDS as a potentially viable additional option for
treatment of hepatic metastases in patients with metastatic ocular
melanoma," said Jennifer K. Simpson,
Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath.
"We look forward to announcing the details of these new data after
they are presented."
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.
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: 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:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.