Analysis From Two Institutions Shows Strong Tumor Response, Overall Survival Potential of Delcath Investigational PHP Therapy...
February 21 2017 - 7:00AM
Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver
cancers, announced that a retrospective, multicenter study
demonstrated that 45.7 percent of patients with ocular melanoma
that metastasized to the liver who underwent percutaneous hepatic
perfusion (PHP) using investigational Melphalan/HDS experienced a
complete or partial response. The study further showed that among
those who responded to treatment, overall survival was projected to
be more than three years.
The findings were reported at the Regional
Cancer Therapies 12th International Symposium in an oral
presentation titled, "Percutaneous Hepatic Perfusion for
Unresectable Metastatic Ocular Melanoma to the Liver: A
Multi-Institutional Report of Outcomes." The analysis was conducted
by teams from Moffitt Cancer Center in Tampa, Fla., and the
University Hospital Southampton in the United Kingdom. The
presentation was led by Dr. Alexandra Gangi of the Moffitt Cancer
Center.
The analysis reviewed outcomes of 49 patients
treated between 2008 and 2016 with Melphalan/HDS at either the
Moffitt Cancer Center or the University Hospital Southampton.
Patients underwent a total of 115 PHP treatments. The median number
of treatments per patient was two, with patients receiving
one-to-six treatments. 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.
Hepatic response to PHP was evaluable in 46
patients, among whom 45.7 percent showed complete or partial
response, and 37.0 percent had stable disease. Median overall
survival was not reached, but was projected to be 657 days (1.8
years). Among patients with a complete or partial response, overall
survival was projected to be 1,207 days (3.4 years). Most common
side effects following treatment were anemia, thrombocytopenia and
neutropenia.
“Patients diagnosed with metastatic ocular
melanoma to the liver have an average of 6-8 months of
survival. This retrospective analysis reported a much longer
survival after Melphalan/HDS , and provided an interesting
long-term look at patient outcomes after treatment with Delcath
Melphalan/HDS,” said Dr. Jennifer K. Simpson, President & CEO
of Delcath. “The projected 657-day median OS and 1,207 day median
OS in those with a partial or complete response is very impressive,
and we believe speaks to the potential of the system to provide
meaningful durable response.”
PHP with Melphalan/HDS was developed by Delcath
Systems as a targeted, whole organ therapy for the liver. It is
commercially available as a device in Europe, where it is marketed
as CHEMOSAT®. The system has not been approved by the U.S. Food and
Drug Administration, and is undergoing Phase 3 clinical
testing in the U.S. as an investigational product.
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