On December 5, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been accepted for publication in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321097 [SID1234522379]). The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center in Tampa, FL and the University Hospital Southampton in the United Kingdom. The publication of the data is expected in an upcoming edition of the Journal. An abstract of this study was presented at the 12th Annual Regional Therapies International Symposium in Snowbird, Utah in February 2017.
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Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "this study represents the largest data set outside of a controlled clinical trial on the use of PHP Therapy in the treatment of uveal melanoma metastatic to the liver. Preliminary results of the study presented at the Regional Therapies conference earlier this year showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies in this patient population. The most common serious side effects following treatment were anemia, thrombocytopenia and neutropenia; these were expected and the majority managed with supportive care. The preliminary data provide confidence that our Phase 3 clinical trial in ocular melanoma liver metastases can provide the evidence necessary to support an application for a labeled indication in this tumor type, and we look forward to the publication of the full study results."
PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.