NEW YORK, Sept. 30, 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 two European investigator-sponsored studies with the
Delcath Hepatic CHEMOSAT® Delivery System
(CHEMOSAT) for the treatment of liver metastases were presented as
posters at the Cardiovascular and Interventional Radiology Society
(CIRSE) annual meeting being held in Lisbon, Portugal, September 26-30, 2015. Details of the CIRSE
scientific program can be found here.
An investigator-sponsored study entitled "Safety and
Efficiency of The Delcath 2nd Generation Filter in
Percutaneous Hepatic Perfusion (PHP) with Melphalan for
Unresectable Hepatic Metastases of Colorectal Cancer and Uveal
Melanoma" conducted at the Leiden University Medical Center
(LUMC) by M.C. Burgmans,
N. de Leede, et al. analyzed safety
and pharmacokinetics of CHEMOSAT. Investigators examined
pharmacokinetic blood samples taken at baseline and set intervals
during 15 PHP procedures performed
with CHEMOSAT on 10 patients. The PHP procedures were performed
with a melphalan dose of 3.0 mg/kg. Results showed grade 3
complications (mostly asymptomatic leukocytopenia and
thrombocytopenia) in seven patients, and febrile neutropenia with
bacterial pharyngitis in one patient. Febrile neutropenia was not
seen again in the study after growth factors were instituted in a
study protocol amendment. First blood sample showed filter
efficiency of 93%. Investigators concluded that the efficiency of
the Delcath 2nd Generation Filter was very high, and
that PHP with the filter was associated with no mortality and
acceptable morbidity consistent with commercial use in Europe.
Another study, entitled "Lessons and Early Results from the
Largest Single Centre Experience in Europe of Treating Ocular Melanoma Liver
Metastases with Chemosaturation via Percutaneous Hepatic
Perfusion" and conducted at Southampton University in the United Kingdom by G. Hickson, I. Wilson,
B. Steadman, et al., reported results from a retrospective analysis
of mortality, morbidity, intra-procedural imaging and complication
data on 22 consecutive patients who were planned for PHP treatment
over a 30-month period. Of the 20 patients who were able to receive
treatment, 11 patients remained alive after a median of 280 days,
with one complete response ongoing at more than one year
post-treatment. Nine deaths from disease progression occurred after
a median of 264 days from the first procedure. A complete imaging
response in the liver was observed in two patients (10%), 13
patients (65%) had a partial liver response and two patients (10%)
had stable disease for more than three months. Investigators
concluded that "PHP is an effective palliative treatment in a bleak
disease with an acceptable side-effect profile."
"The study by investigators from LUMC in the Netherlands represents the first
independent assessment of melphalan pharmacokinetics with our
CHEMOSAT system, and we are pleased to see the 93% filter
efficiency performance they reported," noted Jennifer Simpson, Ph.D., MSN, CRNP, President
and Chief Executive Officer of Delcath. "We are especially pleased
with the consistent safety data presented in both of these
studies. We believe that these efficacy and safety
profiles can be validated in the ongoing and planned studies in our
Clinical Development Program."
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 intrahepatic cholangiocarcinoma (ICC), and expect to
initiate a global Phase 3 trial in ocular melanoma (OM) that has
metastasized to 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: future patient outcomes
and clinical trial results consistent with the data contained in
the SSO abstract, acceptance and publication of the Phase 3 trial
manuscript and the impact of publication to support the Company's
efforts, 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 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 of the presentations at ESSO
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 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.