NEW YORK, May 29, 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 results of a
large, European single-center experience of the treatment of uveal
melanoma patients with hepatic metastases with the Delcath Hepatic
CHEMOSAT® Delivery System, were highlighted in an
on-line abstract at the American Society of Clinical Oncology
Annual Meeting 2015. The abstract is titled, "Single Centre
Experience of Chemosaturation Percutaneous Hepatic Perfusion in the
Treatment of Metastatic Uveal Melanoma" and can be accessed
here.
Uveal melanoma (UM), also known as ocular melanoma, is a rare
cancer of the eye with a very poor prognosis. According to the
study authors, "50% of patients develop distant disease, mainly in
the liver (90%), with a mean survival of 6 months and 1-year
survival rate of 15-20%."
In this study, 20 patients received 34 treatments with CHEMOSAT
(1-3 treatments per patient). Radiologically, 2 patients (10%)
demonstrated stable disease for >3 months, 13 patients (65%) had
a partial response in the liver with complete responses in 2
patients (10%). Nine deaths from disease progression occurred after
a median of 264 days from the first procedure. Eleven patients
remain alive after a median of 280 days with one complete response
ongoing at >1 year. From the diagnosis of liver metastases, 11
patients (55%) have survived to one year and 3 (15%) for >2
years. No procedure related deaths were seen.
Adverse events (AEs) seen were grade 1 (n=12), 2 (n=13), 3 (n=5)
and 4 (n=1). The grade 4 complication was pulmonary edema due to
fluid overload. Early AEs often expected with percutaneous hepatic
perfusion (PHP) were observed including coagulopathy, electrolyte
disturbances and transient transaminases (elevated liver enzymes).
Rare late AEs (1 patient each) included hair loss, skin rash,
myelosuppression and persistent transaminases (elevated liver
enzymes).
"Our results show that PHP (CHEMOSAT) can be used safely to
control hepatic metastases in selected UM patients with a high rate
of hepatic progression free and excellent overall survival,"
concluded lead study author, Guy
Hickson, M.D., Southampton Hospital, Interventional
Radiology, Southampton, United
Kingdom.
"We are especially pleased to have these data shared with the
thousands of oncology specialists from around the world who attend
ASCO. We continue to be encouraged by the growing body of
European commercial patient experience that illustrates CHEMOSAT's
ability to safely and effectively enhance hepatic progression free
and overall survival rates in cancer patients with limited
treatment options and life-limiting disease," noted Jennifer Simpson, Ph.D., President and Chief
Executive Officer of Delcath.
CHEMOSAT is a CE Marked approved product in Europe and is not approved in the United States.
About Ocular (Uveal) Melanoma
According to the
National Cancer Institute, ocular (uveal) melanoma is a rare cancer
that forms from cells that make melanin in the iris, ciliary body,
and choroid. It is the most common eye cancer in adults, affecting
one in every 5 million people in the U.S., with comparable incident
rates 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 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: the impact of the poster
presentation at ASCO 2015 and future clinical results consistent
with the data presented, timely patient enrollment the ability to
complete an interim evaluation of the Company's Global Phase 2 HCC
program, , 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 for certain 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, 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.