Delcath has received orphan drug designation from the US Food and Drug Administration (FDA) for the drug melphalan.
The company is also enrolling patients in Phase II clinical trials to test a new proprietary drug delivery system, known as the Delcath Percutaneous Hepatic Perfusion (PHP) System.
The system provides ultra-high doses of the drug melphalan for the treatment of neuroendocrine tumours metastatic to the liver. It is also used for treating patients with pancreatic islet cell and carcinoid tumours.
Delcath president and CEO Richard Taney said that 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 tumours, is an indication that we have aggressively targeted in our Phase II multi-histology trial,” said Taney.
“These designations, along with our patents and clinical milestones, are important steps in our efforts to secure Delcath’s commercial position on conclusion of our clinical programmes.”