NEW YORK, Oct. 12, 2016 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers,
announces that five clinical sites in Europe have been activated and are open for patient
enrollment in the Company's FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial).
The sites are the first centers in Europe to begin enrolling patients in the FOCUS Trial. One
center, Charité University Hospital in Berlin, Germany, has treated its first patient. Delcath
now has 13 centers in the U.S. and Europe open for patient recruitment, and expects up to 30
centers will participate in the FOCUS Trial.
The following highly-accredited European centers are now open for patient enrollment:
Austria
- University Hospital, Graz
Germany
- Charité University Hospital, Berlin
- University Hospital, Marburg
- University Hospital, Regensburg
United Kingdom
- University Hospital Southampton
"We are pleased to add these highly respected European cancer centers to our FOCUS Trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "This expansion allows Delcath to work
with the some of Europe's top universities and institutes while providing some of Europe's leading clinicians with first-hand knowledge of our therapy, which will continue to be of great
value as we expand our commercial footprint for CHEMOSAT as a treatment for ocular melanoma in Europe."
About the FOCUS Trial
The FOCUS Trial is a global Phase 3 clinical study evaluating the safety, efficacy and pharmacokinetic profile of the
Company's Melphalan/HDS system versus best alternative care in 240 patients with ocular melanoma liver metastases. The FOCUS
Trial's primary endpoint is a comparison of overall survival between the two study arms; secondary and exploratory endpoints
include progression-free survival, overall response rate and quality-of-life measures. The FOCUS Trial is being conducted under a
Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The SPA provides agreement that the Phase 3
trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of
Melphalan/HDS.
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 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). 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.
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: our ability to repay and comply with the obligations under our senior secured
convertible notes, 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, 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 CHEMOSAT/Melphalan HDS system and the
potential of the CHEMOSAT/Melphalan HDS 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 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.