Data on Delcath’s CHEMOSAT System Presented at CIRSE Annual Meeting
September 19 2017 - 08:30AM
Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver
cancers, announces that the results of a single institution study
were presented at the Cardiology and Interventional Radiology of
Europe (CIRSE) annual meeting, held in Copenhagen, Denmark on
September 16-20, 2017.
The study, Prospective Clinical and
Pharmacological Evaluation of the Delcath System’s Second
Generation (GEN2) Hemofiltration System in Patients Undergoing
Percutaneous Hepatic Perfusion (PHP) with Melphalan, was conducted
by a team at the Leiden University Medical Center (LUMC) in Leiden,
The Netherlands and presented by T.S. Meijer, MD. The study
prospectively evaluated filtration efficiency and hematologic side
effects in seven patients who received a total of ten PHP
procedures with the GEN2 CHEMOSAT system. Pharmacokinetic sampling
was conducted at several points during the PHP procedure, and
filtration efficiency was calculated at several discrete points.
Blood tests were conducted following each procedure to
determine hematologic side effect Grade Levels until the blood
values normalized.
Results of the study showed the GEN2 CHEMOSAT
system had an overall efficiency of 86%, with efficiency highest at
the time of highest concentration of melphalan in the blood and
declining as melphalan blood concentration declined. Peak
efficiency was 95.4% in samples taken after 10 minutes of
filtration, 85.9% at the end of the drug infusion period, and 77.5%
at the end of the saline washout period. Researchers noted these
results were superior to and more consistent than prior experience
published with the first generation CHEMOSAT system. Hematologic
side effects were mainly Grade 1 and 2 with some Grade 3 and 4 side
effects emerging post-procedure, including 40% of treatment cycles
showing Grade 4 thrombocytopenia, 80% showing Grade 3 or 4
leucopenia, and 70% showing lymphocytopenia. All patients were
asymptomatic and all lab results normalized in three weeks. Other
adverse events were managed, and there was no mortality, no severe
bleeding complications, and no hypotensive cardiac or cerebral
events. Researchers concluded that the GEN2 CHEMOSAT system appears
to have higher melphalan filter efficiency, more consistent
performance, and appears safe but needs further validation.
Commenting on the study, Dr. Jennifer K.
Simpson, President & CEO of Delcath Systems, said, “This study
provides good external confirmation of the filtration efficiency
capability and consistent performance seen with the GEN2 CHEMOSAT,
and is consistent with what we are seeing in the commercial
setting. This study also indicates that the hematologic side
effects of treatment with CHEMOAT are manageable. We look forward
to validating these observations in our registration trials, which
include robust evaluation of the pharmacokinetic characteristics of
the PHP procedure.”
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 plans to initiate a global registration
trial for 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
StatementsPrivate 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 timing and results of the Company’s clinical trials
including without limitation the OM and ICC clinical trial
programs, timely enrollment and treatment of patients in the
global Phase 3 OM clinical trial, IRB or ethics committee clearance
of the Phase 3 OM and ICC Registration trial protocols
from participating sites and the timing of site activation
and subject enrollment in each trial, the impact of the
presentations at major medical conferences 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 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 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, 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, an orderly
transition to the OTCQB market , 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:Delcath
Investor RelationsEmail: investorrelations@delcath.com