Published Review Shows Delcath Investigational PHP Doubles Overall Survival Over Other Targeted Liver Therapies
February 22 2017 - 8:00AM
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver
cancers, announced today that the American Journal of Clinical
Oncology has published a single-center retrospective review, in
which authors found that investigational PHP with Melphalan/HDS
offers promising results with a doubling of overall survival and
significantly longer progression-free survival (PFS) and hepatic
progression-free survival (HPFS) than other targeted therapies.
Percutaneous hepatic perfusion (PHP) is a minimally invasive
procedure that isolates the liver from the body’s circulatory
system, so that a high dose of chemotherapy (melphalan
hydrochloride) may be infused directly into the liver. Blood from
the liver is then filtered to remove the chemotherapeutic agent
thereby minimizing systemic exposure.
The review, “Hepatic Progression-free and
Overall Survival After Regional Therapy to the Liver for Metastatic
Melanoma,” was written by a team from the Moffitt Cancer Center,
including co-first authors Drs. Andrea M. Abbott and Matthew P.
Doepker, and Jonathan S. Zager, the principal investigator in
Delcath’s ongoing Phase 3 FOCUS study. Drs. Abbott, et al, analyzed
clinical outcomes of three different non-randomized approaches used
to treat 30 patients with liver metastases primarily resulting from
ocular melanoma and skin melanoma. A third of the patients received
PHP using melphalan delivered via the Delcath Hepatic Delivery
System (Melphalan/HDS), 12 received chemoembolization (CE) and six
received radioembolization with yttrium-90 (Y90). Two patients
crossed over once their cancer progressed – one from PHP to Y90 and
one from CE to PHP.
The paper’s authors concluded that patients who
received PHP with Melphalan/HDS had significantly longer median
HPFS at 361 days compared to 54 days for Y90 and 80 days for CE, as
well as a longer median PFS at 245 days compared to 54 days for Y90
and 52 days for CE. Median overall survival was also longest for
PHP at 608 days compared to 295 days for Y90 and 265 days for CE.
The authors noted that further studies, including a randomized
controlled trial, would be needed to confirm whether clinically
superior outcomes can be achieved with PHP compared to other
liver-targeted treatments.
Side effects following all treatments were
similar, with most complications recorded as anorexia, abdominal
pain, fatigue and nausea. Laboratory irregularities, such as
thrombocytopenia and abnormal liver function tests, were seen
immediately after treatment in some patients, but returned to
baseline within a few days.
“The vast majority of patients with metastatic
ocular melanoma survive less than a year, due to the difficulty in
treating metastases to the liver, which are a hallmark of this
cancer. It is therefore especially gratifying to see patients with
this rare disease survive almost two years after receiving PHP with
Melphalan/HDS,” said Dr. Jennifer K. Simpson, President & CEO
of Delcath. “We are hopeful that our ongoing Global Phase 3 FOCUS
study for patient with ocular melanoma liver metastases will yield
similar results, further reinforcing the benefits of our
technology, and bringing us one step closer to U.S. market
availability.”
PHP with Melphalan/HDS was developed by Delcath
Systems as a targeted, whole organ therapy for the liver. The
product is commercially available in Europe under the trade name
CHEMOSAT®, and is being evaluated as an experimental therapy in the
U.S., where a global Phase 3 clinical trial is enrolling patients
with ocular melanoma that has metastasized to the liver.
About Delcath SystemsDelcath
Systems, Inc. is an interventional oncology Company focused on the
treatment of primary and metastatic liver cancers. Our
investigational product—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 and associated side effects. We have
commenced a global Phase 3 FOCUS clinical trial for Patients with
Hepatic Dominant Ocular Melanoma (OM) and 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). Melphalan/HDS has
not been approved by the U.S. Food & Drug Administration (FDA)
for sale in the U.S. In Europe, our system has been
commercially available since 2012 under the trade name Delcath
Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where
it has been used at major medical centers to treat a wide range of
cancers of the liver.
Forward Looking Statements:
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: our ability to repay and comply with the obligations under
our senior secured convertible notes, the timing and results of the
Company's clinical trials including without limitation the
OM, HCC, and ICC clinical trial programs, timely enrollment
and treatment of patients in the global Phase 3 FOCUS Clinical
Trial for Patients with Hepatic Dominant Ocular Melanoma and the
global Phase 2 HCC and ICC clinical trials, 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, if any, of
publication of the Phase 3 trial manuscript to support the
Company's efforts, the impact of the presentations at major medical
conferences and future clinical results consistent with the data
presented, 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, the Company's ability to successfully
commercialize the CHEMOSAT/Melphalan HDS system and the potential
of the CHEMOSAT/Melphalan HDS 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 remaining 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 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:
David Boral
Managing Director
CoreIR
Tel: 516 222 2560
Email: davidb@coreir.com