STAMFORD, Conn.--(BUSINESS WIRE)--At its Annual Meeting of Stockholders today, Delcath Systems, Inc. (Nasdaq:DCTH) updated the enrollment numbers for their Phase III trial of the Delcath System for the region-specific delivery of the chemotherapeutic agent, melphalan, to patients with metastatic melanoma in the liver. This trial is ongoing at the National Cancer Institute (NCI) and was recently approved by the NCI for expansion to a multi-center study. Previously, during an investor conference call and webcast in March 2007, the company had reported the enrollment of 10 patients, and, as of today, the company announced that 15 patients have been treated in this Phase III trial. The randomized Phase III trial calls for treatment of 92 patients diagnosed with ocular and cutaneous melanoma metastatic to the liver. Patients are randomized to either the Delcath system using melphalan or a control group receiving best alternative care. The Phase III trial design allows patients whose tumors grow while on the control arm to be crossed over and receive treatment with the Delcath system. The company also informed shareholders that three of the patients randomized to the control arm have crossed over to receive the Delcath treatment.
