NEW YORK, April 7, 2015 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announces the expansion of its global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment. The Company now has two centers participating in the U.S. Phase 2 HCC study, with another three centers in Germany enrolling patients in the EU Phase 2 HCC study. The Company expects to include up to seven centers in Europe and the United States in its global Phase 2 HCC program, and will seek to enroll approximately 30 patients in total.
HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually. Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 study will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan/HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life.
"We are pleased to have Montefiore Medical Center, a nationally recognized Center of Excellence for cancer care and clinical research, as a part of our global Phase 2 HCC program," said Jennifer Simpson, Ph.D., Delcath's Interim President and CEO. "We now have five centers open for patient enrollment in the program, and with our prospective commercial registry in Europe also now open for enrollment, we are continuing to execute on all elements of our Clinical Development Program."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with an emphasis 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). The Melphalan/HDS system 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 the Melphalan/HDS system 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: timely patient enrollment the ability to complete an interim evaluation of the Company's Global Phase 2 HCC program, 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.
Anne Marie Fields,
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SOURCE Delcath Systems, Inc.