Delcath is enrolling patients in a phase II clinical trial testing its proprietary drug delivery system, known as the Delcath Percutaneous Hepatic Perfusion (PHP) System, with ultra high doses of the drug melphalan for the treatment of neuroendocrine tumors metastatic to the liver. It is also used for treating patients with pancreatic islet cell and carcinoid tumors.
Richard Taney, President and CEO of Delcath, said: We are pleased that the FDA has granted the Company another orphan drug designation. This FDA decision follows two previously granted Delcath orphan drug designations for the drug melphalan for the treatment of patients with metastatic cutaneous melanoma and metastatic ocular melanoma.
High dose melphalan, for the treatment of neuroendocrine tumors, is an indication that we have aggressively targeted in our Phase II multi-histology trial. These designations, along with our patents and clinical milestones, are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our clinical programs, he added.