NEW YORK, March 27, 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 the
reporting of data from a single -center experience utilizing the
Company's Melphalan Hydrochloride for Injection with the Delcath
Hepatic Delivery System (Melphalan/HDS) and other locoregional
therapies in a poster presentation at the Society of Surgical
Oncology (SSO) Annual Meeting 2015. The data were presented
by Andrea Abbott, M.D., Surgical
Oncology, Moffitt Cancer Center in a poster titled "Hepatic
Progression Free and Overall Survival after Regional Therapy to the
Liver for Metastatic Melanoma" as part of the Melanoma and Sarcoma
Session at the meeting. The poster can be accessed on the SSO
website. Melphalan/HDS is an investigational product in the
U.S. and was used in clinical settings at the Moffitt Cancer
Center.
In this retrospective study of 30 patients with cutaneous or
uveal melanoma that metastasized to the liver, investigators
evaluated outcomes on hepatic progression free survival (HPFS),
progression free survival (PFS) and overall survival (OS) following
treatment with yttrium-90 (Y90),
chemoembolization (CE) or percutaneous hepatic perfusion
(PHP). In the study six patients received Y90, 10 patients were treated with PHP, 12
patients were treated with CE, one patient received Y90 after PHP and one patient received PHP
following treatment with CE. Kaplan-Meier survival estimates,
log-rank tests and multivariate time-dependent Cox regression
analyses (MVA) were used to relate patient, tumor and treatment
variables to HPFS, PFS and OS. The study showed a significant
difference in median HPFS with 54 days for patients treated with
Y90, 80 days for patients treated
with CE and 310 days for those treated with PHP (p=0.002).
MVA showed improved HPFS for PHP versus Y90 (p=0.001) and for PHP versus CE (p=0.008),
but not for CE versus Y90
(p=0.44). Median OS from time of treatment was longest for
PHP at 736 days versus Y90 285 days
and CE 265 days; however it did not reach statistical significance.
There was a significant difference on MVA of OS for PHP versus
Y90 (p = 0.03) but not for PHP versus
CE (p=0.37) or CE versus Y90
(0.06).
According to study author, Jonathan Zager, M.D., Surgical
Oncology, Moffitt Cancer Center, the study concluded that, "HPFS
and PFS were significantly prolonged in patients treated with PHP
versus CE and Y90. Median OS in
PHP patients was over double that seen in Y90 or CE patients but
was significant on MVA only between PHP and Y90."
"We are particularly pleased to have these data presented at the
SSO 2015, as it enhances awareness of our Melphalan/HDS among an
audience of the world's premier surgical oncologists," stated
Jennifer Simpson, Ph.D., Interim
President and Chief Executive Officer of Delcath Systems. "In
Europe, where our Hepatic Delivery System is commercially
available, we have also observed encouraging survival data from the
experiences of practitioners using our CHEMOSAT® Delivery System
for Melphalan. Availability of these data is very timely as we
advance plans for our pivotal Phase 3 clinical trial in ocular
melanoma that is metastatic to the liver with overall survival as
the primary endpoint."
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 expect to initiate a global Phase 3 trial in ocular
melanoma (OM) that has metastasized to the liver and plan to
evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2
clinical study.
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.