NEW YORK, March 3, 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
the results from its Phase 3 clinical study, which completed
enrollment in 2009, have been submitted for publication in a
leading peer-reviewed medical journal. The clinical study
utilized Melphalan Hydrochloride for Injection for use with the
Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment
of melanoma patients with liver metastases.
The manuscript details the findings from the Company's Phase 3
clinical study, and is entitled "A Random-Assignment Study of
Hepatic Arterial Infusion of Melphalan with Venous Filtration via
Peripheral (Percutaneous) Hepatic Perfusion (PHP) (Delcath System)
versus Best Alternative Care for Ocular and Cutaneous Melanoma
Metastatic to the Liver." The manuscript was prepared and
submitted by the trial's lead investigator and senior author
James F. Pingpank, Jr., M.D.,
Associate Professor of Surgery at the University of Pittsburgh Medical Center, and by
first author Marybeth S. Hughes,
M.D., Center for Cancer Research, National Cancer Institute, on
behalf of the investigators who participated in the Phase 3
trial.
"The submission of this manuscript is a key milestone for
Delcath and we are optimistic that the manuscript will be accepted
for publication in a peer-reviewed journal. We believe that
future publication will be an important tool in support of our
efforts to obtain reimbursement in a number of European countries
and will also help increase awareness of the value of this
therapy," stated Jennifer Simpson,
Ph.D., MSN, CRNP, Interim President and Chief Executive Officer of
Delcath.
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 a global Phase 2
clinical trial in Europe and the
U.S. to investigate Melphalan/HDS for the treatment of primary
liver cancer (HCC), and expect to initiate a global Phase 3 trial
in ocular melanoma (OM) that has metastasized to the liver and plan
to evaluate intrahepatic cholangiocarcinoma (ICC) in a Phase 2
clinical study.
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: 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:
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/delcath-announces-submission-of-phase-3-trial-results-for-publication-in-a-leading-peer-reviewed-medical-journal-300044245.html
SOURCE Delcath Systems, Inc.