The Delcath system delivers high-dose chemotherapy directly to the liver via the hepatic artery. As blood exits the liver, special filters trap the chemotherapy, protecting the rest of the body from excessive toxicity. The system will be tested with melphalan, an approved anticancer agent.
The company says that the procedure is repeatable and less invasive than traditional surgical ways of performing isolated perfusion to effect dose-directed therapy for specific body organs or regions.
In accordance with the outcomes of the company’s special protocol assessment (SPA) with the FDA, the multi-center trial requires the enrollment of 92 patients to determine whether patients using the Delcath system experience a reduction in tumor burden or zero progression of the tumor for a longer period of time than those receiving best alternative care.
Patients randomized to the control group whose tumors progress will be allowed to cross over and receive treatment using the Delcath system without impacting the study.
“The SPA agreement with the FDA has allowed us to aggressively proceed down the fast track path and we believe that the enrollment of patients will move quickly, and that the results will convince the FDA of the efficacy of our product,” said M.S. Koly, president and CEO of Delcath.