NEW YORK, Dec. 9, 2015 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announces that the results from its Phase 3 clinical study of the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of melanoma patients with liver metastases, have been published in the December issue of the prestigious, peer-reviewed journal, Annals of Surgical Oncology. The study completed enrollment in 2009 and used an earlier version of the Melphalan/HDS and procedure. Melphalan/HDS is investigational in the United States.
The study, "Results of a Randomized Controlled Multi-Center Phase III Trial of Percutaneous Hepatic Perfusion (PHP) Compared to Best Available Care for patients with Melanoma Liver Metastases," by lead investigator and senior author James F. Pingpank, Jr., M.D., Associate Professor of Surgery at the University of Pittsburgh Medical Center, and first author Marybeth S. Hughes, M.D., Center for Cancer Research, National Cancer Institute, et al., compared patients randomly assigned to receive PHP treatments with melphalan using the Melphalan/HDS, or best alternative care (BAC). Patients assigned to the PHP arm were eligible to receive up to six cycles of treatment at approximately four to eight week intervals. Patients randomized to the BAC arm were permitted to cross-over into the PHP arm at radiographic documentation of hepatic disease progression; a majority of the patients in the BAC arm did, in fact, cross over to the PHP arm. Patients who received PHP were given stem cell support in the form of platelet and red blood cell infusions to mitigate toxic side effects of melphalan. The study's primary endpoint was hepatic progression-free survival (hPFS); secondary endpoints included overall progression free survival (oPFS), overall survival (OS), hepatic objective response rate (hOR), and safety.
In the 93 patient study, results showed that patients in the PHP arm had a statistically significant longer median hPFS of 7.0 months compared to 1.6 months in the BAC control group, according to independent imaging review. Median oPFS was 5.4 months vs. 1.6 months for BAC, according to investigator assessment. Median OS for PHP was 10.6 months vs. 10 months for BAC; sub-group analysis revealed that OS among BAC patients who had crossed over to receive PHP was 13.1 months. The hOR was 36.4% for PHP vs. 2% for BAC. With the inclusion of patients with stable disease, overall hepatic disease control rates were 75% for PHP vs. 42.9% for BAC.
The most common post-procedure adverse events (AEs) were related to grade 3 and 4 bone marrow suppression, and included neutropenia (85.7%), thrombocytopenia (80%) and anemia (62.9%). Investigators attributed three deaths to treatment with PHP. An additional death resulting from a gastric perforation occurred in a patient that crossed-over to the PHP arm.
Investigators concluded that the study "demonstrated improved control of liver disease" in patients treated with Melphalan/HDS, and that the "benefit extended to oPFS", suggesting a clear clinical benefit to disease control in the liver in the patient population. Investigators noted that the earlier version of the Melphalan/HDS and PHP procedure utilized in the study was associated with significant morbidity, and recommended modifications such as the use of prophylactic bone marrow growth factors that are already required in the clinical studies that comprise Delcath's current Clinical Development Program in the treatment of primary and metastatic liver cancers.
"Publication of the results of our prior Phase 3 trial in such a prestigious journal is a key milestone for Delcath, and underscores the importance of these data in this area of unmet medical need. In addition, it provides us with an important tool that will enhance our efforts to expand reimbursement in certain European countries," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "Since enrollment in this study was concluded in 2009, the number of treatments administered with the enhanced Melphalan/HDS product and procedure utilized commercially in Europe have exceeded the number treated during the trial. The more recent data from European experience presented at several medical congresses this fall provide us with confidence that an improved safety profile can be demonstrated in the new, pivotal global trial we expect to launch in the coming weeks."
About Delcath Systems Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology with a principal focus 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). Melphalan/HDS 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 intrahepatic cholangiocarcinoma (ICC), 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: the impact, if any, of publication of the Phase 3 trial manuscript 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 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, 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.
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