Delcath Announces Treatment Of First Patient In Phase 2 Trial Of Melphalan Hepatic Delivery System In Primary Liver Cancer

Delcath Systems, Inc. DCTH today announced that the first treatment has been performed in the Company's Global Phase 2 Clinical Program for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC), or primary liver cancer. A team led by Prof. Dr. med. Thomas J. Vogl, Director of the Institute for Diagnostic and Interventional Radiology at Goethe University Hospital Frankfurt, Germany, treated its first case on November 5, 2014. The treating physicians reported that the patient was treated successfully. 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 Europe, the Company's Phase 2 trial program will investigate the safety and efficacy of Melphalan/HDS treatment without 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), and 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 assess patient-reported clinical outcomes, or quality-of-life. The Company's Phase 2 trial program is expected to include four to seven centers in Europe and the United States, and will seek to enroll approximately 30 patients.  "Our team at Goethe University Hospital Frankfurt has been using percutaneous hepatic perfusion with the Melphalan/HDS to treat patients in a non-clinical trial setting since February 2012," said Prof. Vogl. "In our experience, we believe that the Melphalan/HDS has an important role to play in the treatment of a variety of cancers in the liver, including HCC. We are pleased to be participating in this trial to assess the efficacy and safety of Melphalan/HDS in this difficult disease state."  "With treatments now underway and two centers open for enrollment, we believe our Phase 2 HCC Clinical Program is on track," said Dr. Jennifer Simpson, Ph.D., Interim President and CEO of Delcath Systems. We expect to add additional centers to the program in the coming weeks, and subject to timely enrollment of suitable patients, we anticipate having interim data from this trial in the first half of 2015."