Delcath Systems (DCTH) Granted Third Orphan Drug Designation
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Delcath Systems, Inc. (Nasdaq: DCTH) announced that the US FDA granted Delcath's application for orphan-drug designation for the drug melphalan for the treatment of patients with neuroendocrine tumors.
Delcath is enrolling patients in a Phase II clinical trial testing its proprietary drug delivery system, known as the Delcath Percutaneous Hepatic Perfusion System, with ultra-high doses of the drug melphalan for the treatment of neuroendocrine tumors metastatic to the liver. The trial is treating patients with pancreatic islet-cell and carcinoid tumors at the National Cancer Institute in Bethesda, Maryland. Commenting on this orphan-drug designation, Richard L. Taney, President and CEO of Delcath, stated, "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.
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