STAMFORD, Conn.--(BUSINESS WIRE)--Delcath Systems, Inc. (Nasdaq:DCTH) was informed today that the National Cancer Institute (“NCI”) Institutional Review Board (“IRB”) has approved the expansion of the Company’s ongoing Phase III trial to include additional clinical centers. The NCI is currently the only center treating patients in the Phase III pivotal trial of the Delcath System for the region-specific delivery of the chemotherapeutic agent, Melphalan, to patients with metastatic melanoma in the liver. The NCI will continue to treat patients and, under the terms of the recently signed Cooperative Research and Development Agreement (“CRADA”) between the Company and the NCI, it will additionally serve as the coordinating center for the multi-center trial. Delcath has previously announced that the trial is approved for expansion to a maximum of 15 centers by the U.S. Food and Drug Administration (“FDA”).
