DELCATH BEGINS PATIENT TREATMENT IN PHASE III TRIAL

Delcath Systems has announced that the first patient has been treated with the Delcath System in its pivotal Phase III clinical trial for the treatment of metastatic melanoma in the liver using the Delcath system with melphalan, an anticancer agent, at the National Cancer Institute (NCI).

The NCI is the first site to enroll patients in the trial. In accordance with the company's special protocol assessment and agreement (SPA) with the FDA, the multicenter trial requires a enrollment of 92 total patients to determine whether patients using the Delcath system experience a reduction in tumor burden or zero progression of the tumor for a longer period of time than those receiving best alternative care. Patients randomized to the control group whose tumors progress will be allowed to cross over and receive treatment using the Delcath system without affecting the study.