NEW YORK, Oct. 15, 2015 /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 the first
treatment with the Delcath Hepatic CHEMOSAT®
Delivery System for Melphalan (CHEMOSAT) has been performed in
the intrahepatic cholangiocarcinoma (ICC) cohort of the Company's
global Phase 2 clinical trial program for treatment of patients
with unresectable hepatocellular carcinoma (primary liver cancer or
HCC) and ICC. A team led by Prof. Thomas J.
Vogl, M.D., Director of the Institute for Diagnostic
and Interventional Radiology of Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, treated its first patient
on October 13, 2015.
ICC is a tumor in the bile duct that arises within the
liver. It is the second most common primary liver tumor and
represents approximately 15% of new HCC cases diagnosed annually.
Surgical resection, the standard of care, is not possible for an
estimated 80% to 90% of patients diagnosed with ICC.
The ICC cohort of the Phase 2 program is designed to investigate
the efficacy and safety of CHEMOSAT treatment in patients with
unresectable ICC confined to the liver. The study is being
conducted at the same hospitals in Europe participating in the Company's Phase 2
HCC trial. The global Phase 2 HCC/ICC program is evaluating tumor
response (objective response rate) as measured by modified Response
Evaluation Criteria in Solid Tumor (mRECIST), and will assess
progression-free survival and safety. Additional analyses will be
conducted to characterize the systemic exposure of melphalan
administered by CHEMOSAT, as well as to assess patient-reported
clinical outcomes, or quality-of-life.
"Our team has been involved with CHEMOSAT since February 2012," said Prof. Vogl. "The results
we've seen in a non-clinical setting certainly warrant formal
investigation of this therapy's potential in cancers like HCC and
ICC, and we're pleased to be working with our colleagues at major
European cancer centers on the Delcath global Phase 2 HCC/ICC
program."
"ICC patients currently face limited treatment options," said
Jennifer K. Simpson, Ph.D., MSN,
CRNP, President and CEO of Delcath Systems. "We believe that
a positive efficacy signal in this tumor type and good safety
profile may support a regulatory path to a U.S. registration trial,
and that consolidated safety data from the HCC and ICC cohorts of
this global Phase 2 trial will be valuable information for us to
provide to the FDA."
About Delcath Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology with an emphasis 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). The
Melphalan/HDS system has not been approved for sale in the U.S. We
have commenced 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), and expect to
initiate a global Phase 3 trial in ocular melanoma (OM) that has
metastasized to 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: the impact, if any, of
publication of the Phase 3 trial manuscript to support the
Company's efforts, the timing and results of the
Company's clinical trials including without limitation the
HCC, ICC and OM clinical trial programs timely enrollment
and treatment of patients in the global Phase 2 HCC and ICC
clinical trial, 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 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 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-announces-first-patient-treated-in-icc-cohort-of-global-phase-2-hcc-trial-program-300160491.html
SOURCE Delcath Systems, Inc.