Delcath Systems announced encouraging results from the hepatobiliary cohort of the Phase 2 clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer. The primary objective of the trial was to determine the rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration.

Four patient cohorts were included in the study conducted at the National Cancer Institute: hepatobiliary cancers, metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.  Nine patients had tumors of hepatobiliary origin: five hepatocellular carcinoma (HCC) and four cholangiocarcinoma.  Both groups had positive efficacy signals. The HCC cohort results were especially encouraging and consisted of confirmed partial response or durable stable disease. The safety profile was consistent with that reported previously for the Phase 3 melanoma trial.

Delcath’s proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.

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