Delcath Receives Approval To Expand Global Phase 2 HCC Program To Include Patients With Intrahepatic Cholangiocarcinoma

Delcath Systems, Inc.

announces approval of amendments to its Clinical Trial Authorizations (CTAs) filed with the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) and Germany's Federal Institute for Drugs and Medical Devices (BfArM) for the expansion of the Company's global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer, or HCC), to include a cohort of patients with intrahepatic cholangiocarcinoma (ICC). 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 trial will investigate the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver. The study will be conducted at the same hospitals in Europe participating in the Company's Phase 2 HCC trial, and is expected to enroll 11 patients. The ICC cohort will evaluate 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 Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life. "We believe our Melphalan/HDS treatment may offer significant clinical benefit for ICC patients who face limited treatment options, and look forward to enrolling patients in this cohort beginning this quarter," said Jennifer Simpson, Ph.D., Interim President and CEO of Delcath Systems. "A positive efficacy signal may provide a regulatory path to a U.S. registration trial and consolidated safety data from the HCC and ICC cohorts of this global Phase 2 trial will offer valuable information for us to provide to the FDA."