NEW YORK, Jan. 11, 2016 /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 a review of the Delcath Hepatic Delivery System (Melphalan/HDS) for the treatment of patients with liver cancers has been published in Cardiovascular & Interventional Radiology (CVIR), a leading peer-reviewed medical journal.

The review is entitled, "Percutaneous Isolated Hepatic Perfusion for the Treatment of Unresectable Liver Malignancies," by Dr. Mark C. Burgmans, et al. from Leiden University Medical Center (LUMC), in the Netherlands, and includes the first published overview of the enhanced version of the Melphalan/HDS device and procedure. This version of the Melphalan/HDS device and procedure has been used commercially in Europe since 2012 and is being used in the current trials that comprise the Company's clinical development plan. In their update of current literature on percutaneous hepatic perfusion, the LUMC team noted that the current version of the Delcath product and procedure "appear to have reduced the rate and severity of bone marrow suppression" over the previous version of the system. The authors concluded that treatment with Melphalan/HDS "holds promise as a locoregional therapy for patients with hepatic malignancies" and "is a novel, minimally invasive and repeatable alternative for isolated hepatic perfusion."

"The review provides a useful overview of the refinements to both our product and procedure that have been made since the 2010 completion of our prior U.S. Phase 3 trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "We look forward to initiating our new Global Phase 3 trial in hepatic dominant ocular melanoma, and are confident that the improvements in the reduction of toxicities noted by the LUMC team can be formally validated in this pivotal study. We look forward to working further with LUMC and others to realize the potential identified in this review."
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.

More HCB News