History

The Evolution of Chemosaturation Therapy

Regional chemotherapy delivery techniques began in the mid–20th century with isolated limb perfusion (ILP) performed to treat melanoma. This treatment method was the first to be based on the concept of isolating an organ (or extremity) and perfusing it with a high dose of chemotherapy.

Refinements and improvements of this technique took place over the following years. Later, in the 1980s and 1990s, isolated hepatic perfusion (IHP) expanded the concept of regional high-dose chemotherapy to the liver. Investigators at the National Cancer Institute (NCI) and elsewhere refined these surgical methods to completely isolate the liver and to establish a recirculating vascular perfusion circuit. By the mid-1990s, the need for a minimally invasive method to accomplish organ isolation and perfusion was met by Delcath’s development of chemosaturation therapy via percutaneous hepatic perfusion (PHP).

At Delcath, we’ve continued to build on this body of research with three goals in mind:

  • Isolating the affected organ through a minimally invasive and repeatable method
  • Delivering ultra-high doses of chemotherapeutic agent to the isolated organ
  • Minimizing systemic exposure to chemotherapeutic agents using chemofiltration

Our initial research focus has been on the treatment of metastatic liver cancers. Hepatic tumors get the majority of their blood from the arteries, and the hepatic anatomy is amenable to isolation of its venous outflow. This allows for the minimally invasive vascular isolation of the liver, chemosaturation via the hepatic artery, and extracorporeal filtration of the exiting hepatic venous blood.

In 2010, Delcath concluded a phase 3 study of ocular and cutaneous melanoma that had metastasized to the liver, as well as a multi-arm phase 2 trial to treat other liver cancers. Our proprietary Hepatic CHEMOSAT® Delivery System has obtained CE Mark approval in Europe for administration of melphalan hydrochloride to the liver. In the United States, Delcath’s system for chemosaturation is an investigational product and is not approved by the U.S. Food and Drug Administration.