NEW YORK, Sept. 19, 2016 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on treatments for primary and metastatic liver cancers, announces that the company provided a grant to the Ocular Melanoma Foundation (OMF) in support of the organization's 6th Annual Eye Am Not Alone (EANA) patient education retreat, held in Miami, Florida at the Bascom Palmer Eye Institute on September 9-11, 2016. Delcath supported a lecture by Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, and principal investigator for the Company's FOCUS Phase 3 Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial).
The EANA is an annual conference and patient education seminar organized by the OMF and hosted by some of the leading research institutions working on treatments for ocular melanoma. The EANA retreat offers patients and caregivers opportunities to learn about treatment options, clinical trials and other resources available to them as they contend with this difficult to treat cancer.
"Patient advocacy organizations like the OMF are vital sources of support for patients facing an ocular melanoma diagnosis," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We were pleased to sponsor this important conference, and look forward to supporting the mission of the OMF and other patient advocacy organizations working on ocular melanoma in the future."
About the Ocular Melanoma Foundation
The Ocular Melanoma Foundation (OMF) is the leading research and patient support organization focused on eye cancer. OMF was established by Dr. Robert Allen, a renowned eye surgeon who was diagnosed with ocular melanoma (OM), a rare eye cancer diagnosed in 2,000 adults in the U.S. annually. Today, OMF is the #1 destination for uveal melanoma information online and a leading provider of patient education and support programs, including novel assistance programs for patient travel and ocular prosthetics. The 'Eye Am Not Alone' patient retreat is the largest gathering of OM patients and caregivers in the world and OMF has raised over a million dollars towards the fight against eye cancer while partnering closely with the American Association for Cancer Research (AACR) and the Rare Cancer Research Foundation (RCRF) to fund groundbreaking cancer research. Learn more at www.ocularmelanoma.org
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.
Anne Marie Fields
SOURCE Delcath Systems, Inc.