NEW YORK, Sept. 19, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), an interventional oncology company
focused on treatments for primary and metastatic liver cancers,
announces that the company provided a grant to the Ocular Melanoma
Foundation (OMF) in support of the organization's 6th
Annual Eye Am Not Alone (EANA) patient education retreat,
held in Miami, Florida at the
Bascom Palmer Eye Institute on September
9-11, 2016. Delcath supported a lecture by Jonathan Zager, M.D., FACS, Professor of Surgery
in the Cutaneous Oncology and Sarcoma Departments and a Senior
Member at Moffitt Cancer Center, and principal investigator for the
Company's FOCUS Phase 3 Clinical Trial for Patients with Hepatic
Dominant Ocular Melanoma (the FOCUS Trial).
The EANA is an annual conference and patient education seminar
organized by the OMF and hosted by some of the leading research
institutions working on treatments for ocular melanoma. The EANA
retreat offers patients and caregivers opportunities to learn about
treatment options, clinical trials and other resources available to
them as they contend with this difficult to treat cancer.
"Patient advocacy organizations like the OMF are vital sources
of support for patients facing an ocular melanoma diagnosis," said
Jennifer K. Simpson, Ph.D., MSN,
CRNP, President and Chief Executive Officer of Delcath. "We were
pleased to sponsor this important conference, and look forward to
supporting the mission of the OMF and other patient advocacy
organizations working on ocular melanoma in the future."
About the Ocular Melanoma Foundation
The Ocular Melanoma Foundation (OMF) is the leading research and
patient support organization focused on eye cancer. OMF was
established by Dr. Robert Allen, a
renowned eye surgeon who was diagnosed with ocular melanoma (OM), a
rare eye cancer diagnosed in 2,000 adults in the U.S. annually.
Today, OMF is the #1 destination for uveal melanoma information
online and a leading provider of patient education and support
programs, including novel assistance programs for patient travel
and ocular prosthetics. The 'Eye Am Not Alone' patient retreat is
the largest gathering of OM patients and caregivers in the world
and OMF has raised over a million dollars towards the fight against
eye cancer while partnering closely with the American Association
for Cancer Research (AACR) and the Rare Cancer Research Foundation
(RCRF) to fund groundbreaking cancer research. Learn more at
www.ocularmelanoma.org
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:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.