NEW YORK, Sept. 28, 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
data from two EU treatment centers supporting treatment of patients
with liver metastases from ocular melanoma with the Delcath Hepatic
CHEMOSAT® Delivery System (CHEMOSAT) will
be presented as a poster at the European Cancer Congress (ECCO)
annual meeting, being held in Vienna,
Austria from September 25-29,
2015.
The study entitled, "Treating Unresectable Liver Metastases
of Uveal Melanoma with (Percutaneous) Isolated Hepatic Perfusion
with Melphalan: Results from Two Experienced Centers," by
E.M. De Leede, M.C. Burgmans, et al., was a retrospective study
conducted by investigators at Leiden University Medical Center
(LUMC) and Erasmus Medical Center (EMC) in the Netherlands. Investigators compared
patients with uveal (ocular) melanoma liver metastases treated with
isolated hepatic perfusion (IHP), an open surgical procedure that
can be performed only once, with patients treated with repeatable
percutaneous hepatic perfusion (PHP) using the CHEMOSAT
system with an aim to treat patients twice with a six week
interval. Treatment characteristics, complications, toxicity,
progression free and overall survival of both therapeutic
approaches were analyzed. Both IHP and PHP treatments were
performed with melphalan.
In the IHP cohort (30 patients treated between March 1999 and April
2009) progression free survival was 6 months and recurrence
was mainly in the liver, and overall survival was 10 months. In the
PHP cohort (9 patients who received 15
PHP treatments since February
2014), the maximum follow-up period was 14 months. Eight
patients are still alive, seven without progression of disease. A
decrease in red and white blood cell count and thrombocytes after
the procedure was observed, and 3 patients needed blood
transfusions or platelet infusion. Treatment was overall well
tolerated. Investigators concluded that "percutaneous hepatic
perfusion appears to be an effective and safe procedure in selected
patients with unresectable liver metastases of colorectal cancer or
uveal melanoma and can be repeated."
"With eight out of nine patients still alive at 14 months in
this retrospective analysis, this is an encouraging signal for PHP
and we look forward to seeing the final data," said Jennifer Simpson, Ph.D., MSN, CRNP, President
and CEO of Delcath Systems. "This study is the first of several
scheduled posters on the clinical merits of CHEMOSAT to be
presented at major medical meetings this fall. We expect this
growing body of clinical data will advance the continued adoption
of CHEMOSAT in Europe and will
support our ongoing reimbursement efforts in those
territories."
The abstract of this study is available on the ECCO 2015
website.
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: future patient outcomes
and clinical trial results consistent with the data contained in
the SSO abstract, acceptance and publication of the Phase 3 trial
manuscript and the impact of publication 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 ESSO
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 Value 4 status 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:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.