NEW YORK, April 18, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, commended Spire Southampton Hospital on the performance of over 100 percutaneous hepatic perfusion (PHP®) procedures with CHEMOSAT®. PHP with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. The product is commercially available in Europe under the trade name CHEMOSAT, and is being evaluated as an investigational therapy in the U.S. Delcath is currently enrolling patients in the FOCUS trial, a global Phase 3 clinical trial that is investigating PHP with Melphalan/HDS as a treatment for patients with ocular melanoma that has metastasized to the liver.
PHP is a minimally invasive procedure that isolates the liver from the body’s circulatory system, so that a high dose of chemotherapy (melphalan hydrochloride) may be infused directly into the liver with the potential to treat both visualized and non-visualized metastases. Blood from the liver is then filtered to remove the chemotherapeutic agent thereby minimizing systemic exposure and potentially the associated side effects.
As part of the Spire Southampton’s celebration of this milestone, a hospital statement highlighted the case of Brian Carney, a retired businessman from Leeds, UK. Mr. Carney was initially diagnosed with ocular melanoma in 2005, and in 2013 physicians discovered the disease had metastasized to his liver. Prognosis after ocular melanoma has metastasized in the liver is poor with a median survival of six months. In the case of Mr. Carney, he was referred to Spire Southampton, and received his first PHP treatment in December 2013. In the intervening period, he has also undergone liver resections and immunotherapy treatments. He recently became the first patient in the world to receive eight PHP treatments, which controlled the tumor and allowed him to conduct normal daily activities at his home. Mr. Carney remains under the care of Spire Southampton where his condition is regularly checked between therapies.
About Spire Southampton
Spire Southampton Hospital is a leading independent hospital group in the United Kingdom with 38 hospitals and 12 clinics across England, Wales and Scotland. The hospital is a leading CHEMOSAT-treatment center, performing the highest number of recorded PHP treatments in the world.
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, 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.
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