Delcath’s chemosaturation system is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body.

The Phase II clinical trial conducted at the National Cancer Institute (NCI) in the US included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.

Delcath System president and CEO Eamonn Hobbs said while the efficacy signal from this study was inconclusive, they believe there is a clinical and scientific justification to conduct a new Phase II trial in a well-defined metastatic colorectal (mCRC) patient population who are likely to benefit from chemosaturation with percutaneous hepatic perfusion.

The company plans to initiate a new Phase II single-arm study to evaluate the efficacy of Delcath’s chemosaturation system and its next-generation high efficiency filter in patients with colorectal cancer that is metastatic to the liver and is refractory to first line systemic chemotherapy.