Delcath Systems treats first patient using hepatic delivery system for ICC

Delcath Systems, Inc. announced that a global phase 2 trial is underway and the first patient has been treated using Chemosat, its investigational hepatic delivery system of melphalan for the treatment of intrahepatic cholangiocarcinoma and unresectable hepatocellular carcinoma.

According to a press release, the patient is part of a cohort of patients with intrahepatic cholangiocarcinoma (ICC) and included in a phase 2 clinical trial that is investigating the efficacy and safety of Chemosat (Delcath Systems)-administered treatment in patients with unresectable ICC confined to the liver. The study is currently underway at various hospitals in Europe that also participated in the company's phase 2 clinical trial for HCC.

“Our team has been involved with Chemosat since February 2012,” Thomas J. Vogl, MD, director of the Institute for Diagnostic and Interventional Radiology, Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, and trial investigator, said in the release. “The results we’ve seen in a non-clinical setting certainly warrant formal investigation of this therapy’s potential in cancers like HCC and ICC, and we're pleased to be working with our colleagues at major European cancer centers on the Delcath global phase 2 HCC/ICC program.”

“The global phase 2 HCC/ICC program is evaluating tumor response as measured by modified Response Evaluation Criteria in Solid Tumor and will assess progression-free survival and safety,” according to the release. “Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Chemosat, as well as to assess patient-reported clinical outcomes, or quality-of-life.”

“ICC patients currently face limited treatment options,” Jennifer K. Simpson, PhD, MSN, CRNP, president and CEO of Delcath Systems, said in the release. “We believe that a positive efficacy signal in this tumor type and good safety profile may support a regulatory path to a U.S. registration trial, and that consolidated safety data from the HCC and ICC cohorts of this global phase 2 trial will be valuable information for us to provide to the FDA.”

Disclosures: Simpson is an employee of Delcath Systems. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Vogl at the time of publication.