NEW YORK, Nov. 2, 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 three studies supporting treatment for liver metastases
with the Delcath Hepatic CHEMOSAT® Delivery
System (CHEMOSAT) were presented at the European Association of
Dermato Oncology (EADO) annual congress, which was held in
Marseille, France, October 28-31, 2015.
Details of the presentations are as follows:
Liver Directed Treatment Of Metastatic Uveal Melanoma By
Chemosaturation Via Percutaneous Hepatic Perfusion – A Single
Centre Experience, Southampton
University (United Kingdom),
presented by lead author Dr. Ioannis
Karydis. Researchers conducted a retrospective evaluation of
20 patients treated with CHEMOSAT over 3 years, analyzing survival,
tumor response, time to progression and treatment related adverse
events. Eighteen patients were able to receive treatment, and 17 of
these were evaluable for study purposes. Results showed that ten
patients remained alive after median 256 days, with
one complete response (6%), four partial responses (24%), and
eleven (65%) patients with stable disease for greater than 90 days.
Progression free survival for patients who had progressed was 181
days at the time of data cut off, and six patients were alive for
greater than one year following their first treatment. Eight deaths
from disease progression occurred at a median of 241 days following
first treatment, and there were no treatment related deaths.
Treatment overall was well tolerated, and non-hematological adverse
events were rare (3). Most common adverse events were transient,
mild <grade 2 and included transaminitis (56%) and
thrombocytopenia (89%); grade 3 anemia was seen in 4 patients and
grade 2-4 neutropenia was seen in 4 patients. Researchers concluded
that "PHP can be used safely by an experienced team to deliver
liver-directed therapy in selected uveal melanoma patients with
high progression free and excellent overall survival."
Treating Unresectable Liver Metastases Of Uveal Melanoma With
Percutaneous Hepatic Perfusion With Melphalan, Leiden
University Medical Center, Erasmus Cancer Institute (the Netherlands) presented by Dr. Mark Burgmans (Leiden). This is an
active two-center Investigator Initiated Phase 2 study that
aims to evaluate 20 patients with uveal, or ocular melanoma treated
with PHP (CHEMOSAT). Data from the first 11 patients with a maximum
follow up period of 16 months were presented. Primary endpoints for
the study are response rate (as measured by RECIST criteria)
following two treatments at 6-week intervals and the percentage of
patients with stable disease. Secondary endpoints are safety,
overall survival, hepatic progression free survival, and quality of
life. Eighteen treatments have been performed on eleven patients
and the maximum follow up is currently sixteen months. Current
results are that ten patients remain in follow up, and four are
without progression of disease. Four patients experienced grade 3
or 4 toxicities that were managed with blood or platelet
transfusions. The researchers concluded that PHP with CHEMOSAT
"appears to be an effective and safe procedure in selected patients
with unresectable liver metastases of uveal melanoma and can be
repeated."
Chemosaturation with Percutaneous Hepatic Perfusion of
Melphalan for Hepatic Metastases from Uveal Melanoma:
Multiinstitutional Evaluation. This study was presented as
a poster by lead author Prof. Thomas
Vogl, Frankfurt University Hospital and was a retrospective
evaluation of non-resectable hepatic metastases from uveal melanoma
in 14 patients treated with CHEMOSAT between 2012 and 2014. Eleven
patients who received one to three treatments were evaluated by
RECIST criteria; survival time analysis was conducted and
complications were recorded. Results showed 4 patients (36%) with a
partial response, five (46%) with stable disease, and two (18%)
with progressive disease. Survival time ranged between 1.5 months
to 23 months, with median overall survival of 6.5 months. Time to
progression for the two patients who had progressed was 6.2 months
for one patient and 1.6 months for a patient who died after
evaluation. Treatment was well tolerated by all 14 patients,
with seven experiencing leukopenia, six had thrombocytopenia, and
two had neutropenia. Researchers concluded that PHP with CHEMOSAT
"has been manifested as a potential treatment for patients with
non-resectable hepatic metastases of uveal melanoma."
"These studies complement others presented at major medical
conferences this fall in examining the potential for treatment with
CHEMOSAT for unresectable liver metastases," said Dr. Jennifer K. Simpson, President & CEO of
Delcath Systems. "We are pleased with the quality and pace of
research being presented and published recently, and look forward
to building on this momentum to further advance the commercial and
clinical adoption of CHEMOSAT in Europe."
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:
Investor Contact:
LHA
Anne Marie Fields,
afields@lhai.com
212-838-3777
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SOURCE Delcath Systems, Inc.