NEW YORK, Dec. 05, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology
company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective
analysis of Delcath’s PHP® Therapy have been accepted for publication in the peer-reviewed Journal of Surgical Oncology.
The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an
Orphan Disease, was conducted by researchers from Moffitt Cancer Center in Tampa, FL and the University Hospital Southampton
in the United Kingdom. The publication of the data is expected in an upcoming edition of the Journal. An abstract of this study was presented at the 12th Annual Regional Therapies
International Symposium in Snowbird, Utah in February 2017.
Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, “this
study represents the largest data set outside of a controlled clinical trial on the use of PHP Therapy in the treatment of uveal
melanoma metastatic to the liver. Preliminary results of the study presented at the Regional Therapies conference earlier this year
showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies
in this patient population. The most common serious side effects following treatment were anemia, thrombocytopenia and neutropenia;
these were expected and the majority managed with supportive care. The preliminary data provide confidence that our Phase 3
clinical trial in ocular melanoma liver metastases can provide the evidence necessary to support an application for a labeled
indication in this tumor type, and we look forward to the publication of the full study results.”
PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the
liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT®. The system has not been
approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an
investigational product.
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 plan to initiate a Registration trial for intrahepatic cholangiocarcinoma (ICC) in the fall of 2017.
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 Statements
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 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 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 Relations
Email: investorrelations@delcath.com
