With an initial potential market opportunity in ocular melanoma liver metastases of between $104 million and $260 million at stake, Delcath Systems (NASDAQ: DCTH) is working with the U.S. FDA toward approval of the company’s Melphalan/Hepatic Delivery System (Melphalan/HDS) chemotherapy system for treatment of certain unresectable liver cancers. The Melphalan/HDS system facilitates the delivery of melphalan directly to the liver and, consequently, allows the administration of higher doses. The blood is then filtered to reduce the level of melphalan and returned to the patient, thereby potentially reducing hematologic side effects. In 2016, Delcath initiated its global FOCUS phase 3 trial in hepatic dominant ocular melanoma, a cancer that often metastasizes to the liver. The FOCUS trial is currently open for patient enrollment at 15 prestigious cancer centers in the United States and Europe. The company expects to open 25 additional centers for enrollment in 2017. Delcath is also investigating its therapy in intrahepatic cholangiocarcinoma, a form of bile duct cancer. In 2016, the company secured approximately $35 million in financing to support its commercial activities in Europe and to fund its clinical development plan through to the end of 2017.
To learn more, visit www.delcath.com
Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Its investigational product – Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) – is designed to administer high dose chemotherapy to the liver while controlling the systemic and associated side effects. The Company’s principal focus is on the treatment of primary and metastatic liver cancers. In the United States, the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA).
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