On October 15, 2015 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, reported that the first treatment with the Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT) has been performed in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company’s global Phase 2 clinical trial program for treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer or HCC) and ICC (Press release, Delcath Systems, OCT 15, 2015, View Source;p=RssLanding&cat=news&id=2097545 [SID:1234507719]). A team led by Prof. Thomas J. Vogl, M.D., Director of the Institute for Diagnostic and Interventional Radiology of Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, treated its first patient on October 13, 2015.
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ICC is a tumor in the bile duct that arises within the liver. It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
The ICC cohort of the Phase 2 program is designed to investigate the efficacy and safety of CHEMOSAT treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company’s Phase 2 HCC trial. The global Phase 2 HCC/ICC program is evaluating tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. 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.
"Our team has been involved with CHEMOSAT since February 2012," said Prof. Vogl. "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."
"ICC patients currently face limited treatment options," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "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."