NEW YORK, June 2 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration ("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 ("PHP") System(TM), 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. 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."
Orphan drug designation, when granted by the FDA's Office of Orphan Products Development, allows for up to seven years of
|SOURCE Delcath Systems, Inc.|
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