Delcath Adds New U.S. Center To Global Phase 2 Hepatocellular Carcinoma Program

Delcath Systems, Inc.

announces the expansion of its global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (HCC) or primary liver cancer. Montefiore Medical Center in the Bronx, New York has joined the U.S. Phase 2 HCC study and is now open for patient enrollment. The Company now has two centers participating in the U.S. Phase 2 HCC study, with another three centers in Germany enrolling patients in the EU Phase 2 HCC study. The Company expects to include up to seven centers in Europe and the United States in its global Phase 2 HCC program, and will seek to enroll approximately 30 patients in total. HCC is the most common primary cancer of the liver, with approximately 700,000 new cases diagnosed worldwide annually. Surgical removal is not possible for an estimated 80-90 percent of primary liver cancer patients. In the U.S., the Phase 2 study will investigate the safety and efficacy of Melphalan/HDS treatment followed by sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response (objective response rate), as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), assess progression-free survival, safety, and the safety of sorafenib following treatment with Melphalan/HDS. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as an assessment of patient-reported clinical outcomes, or quality-of-life. "We are pleased to have Montefiore Medical Center, a nationally recognized Center of Excellence for cancer care and clinical research, as a part of our global Phase 2 HCC program," said Jennifer Simpson, Ph.D., Delcath's Interim President and CEO. "We now have five centers open for patient enrollment in the program, and with our prospective commercial registry in Europe also now open for enrollment, we are continuing to execute on all elements of our Clinical Development Program."