NEW YORK, Jan. 12, 2017 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), an interventional oncology Company focused on
the treatment of primary and metastatic liver cancers, announces
that patient treatment and data collection for the intrahepatic
cholangiocarcinoma (ICC) cohort of its European Phase 2 HCC/ICC
study is ongoing, and that the Company will announce interim
results for the cohort once the data are fully mature.
Additionally, the Company believes that the original goal to obtain
an efficacy signal for the Phase 2 ICC cohort has been satisfied by
the result of multicenter patient outcomes identified in the
retrospective data collection of our commercial ICC cases conducted
by our European investigators. These promising outcomes and
observations were discussed with Key Opinion Leaders (KOL) at a
Delcath-organized medical advisory panel meeting and led to the
agreement that PHP® therapy does, indeed, "demonstrate
an efficacy signal in ICC and is worthy of full clinical
investigation."
The Company also announces that it has accepted an invitation
from The Cholangiocarcinoma Foundation (CCF) to present its
initial research plans for use of PHP® therapy in the
treatment ICC. The CCF is the largest patient advocacy
organization devoted to finding a cure and improving the quality of
life for patients with cholangiocarcinoma, or bile duct cancers.
Company representatives will present a summary of European
investigator findings and its clinical development plans for ICC to
the Foundation's medical advisory board at the CCF's 2017 Annual
Meeting, to be held in Salt Lake City,
UT from February 1-3, 2017.
Delcath will also provide a sponsorship grant to support the work
of the CCF as part of its participation in the CCF Annual
Meeting.
"Though the interim data we expected for ICC cohort in our Phase
2 trial in HCC/ICC are not yet available, the objectives for this
study have largely been satisfied by the independent retrospective
analysis conducted by our European investigators" said Jennifer K. Simpson, Ph.D., MSN, CRNP, President
and Chief Executive Officer of Delcath. "The promising outcomes and
observations identified at our global KOL forum last year provide
us with considerable confidence in the potential of our therapy in
the ICC tumor type and helped form our initial research plan. The
future research in ICC is designed to be cost effective and pursued
in a financially prudent manner."
Dr. Simpson continued, "the CCF is one of the most important
organizations for patients diagnosed with bile duct cancers, and
the organization has attracted the participation of some of the
leading researchers working on this difficult to treat disease. We
are delighted with the opportunity to present to KOLs in this space
the potential that the European investigators have identified for
our therapy in the treatment of ICC."
About ICC
ICC is the second most common primary liver
tumor and represents approximately 15% of new hepatocellular
carcinoma (primary liver cancer or HCC) cases diagnosed annually.
Surgical resection, the standard of care, is not possible for an
estimated 80% to 90% of patients diagnosed with ICC.
About the Cholangiocarcinoma Foundation
Now celebrating its 10th Anniversary, CCF is a global 501(c)
(3) non-profit organization whose mission is to find a cure and
improve the quality of life for those affected by bile duct cancer
through advocacy, education, collaboration and research.
Visit www.cholangiocarcinoma.org to learn more.
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.