Delcath has developed a percutaneous targeted, whole-organ treatment that delivers a select high-dose chemotherapy agent directly to the liver, while minimizing side effects by filtering the chemotherapeutic drug from the blood before returning it to the patient.
In the US, our investigational product is being developed under the technical name Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS). Melphalan/HDS has not been approved by the U.S. Food & Drug Administration. It is under evaluation in a global Registration trial (link to FOCUS page) for treatment of patients with ocular melanoma metastasized to the liver. Other trials in the US and Europe are investigating Melphalan/HDS for intrahepatic cholangiocarcinoma (a form of bile duct cancer).
In Europe our product is referred to as Delcath Hepatic CHEMOSAT® Delivery System (“CHEMOSAT”). CHEMOSAT was CE Marked in 2012 to treat patients with cancers of the liver. The CHEMOSAT medical device is now available at many of Europe’s leading oncology centers, with over 700 patients having received the treatment.
Liver-directed high dose chemotherapy evolved from a highly invasive open surgical procedure to a minimally invasive procedure known as percutaneous hepatic perfusion (PHP). During PHP, three catheters are placed percutaneously through standard interventional radiology techniques. The liver is temporarily isolated from the body’s circulatory system, during which time a 30 minute infusion of the chemotherapeutic agent melphalan hydrochloride directly to the liver occurs. The blood is collected as it exits the liver for filtration by proprietary filters prior to returning it to the patient.
In the United States, Delcath’s system for PHP has been evaluated in a Phase 3 trial for patients with unresectable ocular and cutaneous liver metastases. Additional cancers including colorectal cancer, neuroendocrine tumors and in patients with hepatocellular carcinoma (primary liver cancer) have been studied.