Data Supporting CHEMOSAT Presented at the Cardiovascular and Interventional Radiology Society of Europe Conference
September 14 2016 - 8:30AM
Business Wire
Single-Institution Studies Add to Growing
Body of Research Supporting CHEMOSAT for Treatment of Cancers of
the Liver
Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology
Company focused on developing safe and effective treatments for
primary and metastatic liver cancers, announces that results from
two single-institution studies conducted in Germany of use of the
Delcath Hepatic CHEMOSAT® Delivery System to treat patients with
liver metastases were presented as posters at the Cardiovascular
and Interventional Radiology Society of Europe (CIRSE) annual
meeting.
The first study, Secondary Resectability of Ocular Melanoma
Liver Metastases (OMLM) Following Percutaneous Hepatic Perfusion
(PFP) by M. Zeile, et al. of the Asklepios Barmbek Clinic in
Hamburg, Germany, evaluated 7 patients with unresectable ocular
melanoma liver metastases treated with CHEMOSAT. There were 12
CHEMOSAT procedures administered in total, with a median of 2
cycles per patient, and a range of 1 to 3. The objective response
rate after 1-2 treatments was 71.4%. Two patients showed secondary
resectability on imaging after completing two treatments and remain
alive for over 26 months following resections. Progression free
survival was 9.9 months and hepatic progression free survival was
11.2 months. Median survival for the study has not yet been
reached, but is higher than 16.9 months. There were no adverse
events of grade 3 or higher. Investigators concluded that CHEMOSAT
is safe to use in these patients and that significant downsizing of
ocular melanoma liver metastases can be achieved with CHEMOSAT.
These researchers concluded that if these promising results were
further validated it “may lead to a new standard of therapy for the
treatment of patients with ocular melanoma liver metastases.”
The second study, Percutaneous Isolated Hepatic Perfusion
(Chemosaturation) In Patients With Primary Or Secondary Liver
Tumours: Experience In 20 Patients, by S. Marquardt et al., of
Hanover Medical School in Hanover, Germany, retrospectively
evaluated patients with advanced disease from primary or metastatic
cancers of the liver. The local response rate (stable disease or
partial response) was 80%. Mean progression free survival was 3.2
months. The investigators reported no major complications and that
bone marrow suppression was common but controllable. The
investigators concluded that patients with primary or secondary
liver tumors that have disease progression under standard therapy
“may profit from PHP with Melphalan,” that technical execution is
problem-free, and complications are manageable.
We are very pleased with the results of these studies, which
both show noteworthy results achieved with CHEMOSAT in difficult to
treat patients with few effective options,” said Jennifer K.
Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of
Delcath. “These single-institution studies add to the growing body
of research that support a significant role for CHEMOSAT in the
management of patients with cancers of the liver.”
The CIRSE conference is being held in Barcelona, Spain at the
Centre de Convencions Internacional de Barcelona from September
10-14, 2016. Additional information for the CIRSE Scientific
Program is available here.
About Delcath Systems
Delcath 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.
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.
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LHAInvestor Contact:Anne Marie Fields,
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