NEW YORK, July 6, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and
medical device company focused on treatment of primary and
metastatic liver cancers, announces that data from a large single
hospital experience conducted at Southampton University Hospital in
the United Kingdom were presented
in an oral presentation at the 6th European Post-Chicago
Melanoma/Skin Cancer Meeting held in Munich, Germany from June 30 – July 1,
2016.
The abstract, Chemosaturation Via Percutaneous Hepatic
Perfusion – An Update On A Single Centre Experience Of
Treating Metastatic Uveal Melanoma, Southampton University (United Kingdom) was presented by lead author,
Ioannis Karydis, M.D, of Southampton
University Hospital. Researchers conducted a retrospective
evaluation of 27 metastatic uveal melanoma patients treated with
CHEMOSAT over four years, analyzing survival, tumor response, time
to progression and treatment related adverse events. Two patients
could not be treated and were excluded from analysis; 25 patients
received 43 treatments. Results showed that 14 patients remained
alive after a median 290 days. Of 24 evaluable patients,
one patient had a complete response (4%), five patients had
partial responses (21%), and 12 patients had stable disease for
greater than 90 days (50%). Progression free survival for patients
who had progressed was 181 days at the time of data cut off, and 11
patients were alive for greater than one year following their first
treatment with a projected media overall survival of 511 days.
Eleven deaths from disease progression occurred at a median of 264
days following first treatment, and there were no treatment related
deaths. Treatment overall was well tolerated, and non-hematological
adverse events (6) were relatively rare. Most common adverse events
were transient, mild <grade 2 and included transaminitis (64%)
and thrombocytopenia (88%); grade 3 anemia was seen in 36% of
patients and grade 3-4 neutropenia was seen in 6 patients.
Researchers concluded that "PHP can be used safely by an
experienced team to deliver liver-directed therapy in selected
uveal melanoma patients, and achieves unprecedented progression
free and overall survival."
"The progression free and overall survival benefits observed in
this study are dramatic, especially given the limited treatment
options for patients suffering with these life-threatening
cancers. Importantly, these supportive data provide us with
considerable confidence that similar results may be formally
validated by our FOCUS Phase 3 Trial in hepatic dominant ocular
melanoma that is currently underway in the U.S. and Europe to secure marketing authorization in
the U.S.," said Jennifer K. Simpson,
Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "The
quality and pace of global research being presented and published
continues to strongly support CHEMOSAT as a therapy for metastatic
liver cancer. We look forward to building on this momentum to
further advance the commercial and clinical adoption of CHEMOSAT in
Europe, the U.S. and around the
world."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and
medical device company focused on oncology with a principal focus
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).
Melphalan/HDS has not been approved for sale in the U.S. We have
commenced our 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).
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: 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, 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, 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 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 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.
Investor Contact:
Anne Marie
Fields
LHA
212-838-3777
afields@lhai.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/european-data-supporting-survival-benefit-with-delcaths-chemosat-system-presented-at-6th-european-post-chicago-melanomaskin-cancer-meeting-300294307.html
SOURCE Delcath Systems, Inc.