Drug & Device Development

Delcath sends melphalan directly into liver via hepatic artery

Last Updated: 2010-06-07 19:38:08 -0400 (Reuters Health)

By Deena Beasley

CHICAGO (Reuters) - A drug delivery system developed by Delcath Systems Inc helped melanoma patients with liver metastases survive more than twice as long as patients treated with best available care.

The company, which announced in April that the 93-patient trial was successful, said patients with hepatic lesions from ocular or cutaneous melanoma who were treated with its "Percutaneous Hepatic Perfusion" had a median overall survival of 298 days, compared to 124 days in controls. Median progression-free survival was 245 days with the Delcath system, vs 49 days with standard care.

Delcath's "chemosaturation" approach delivers high doses of melphalan directly to the liver, through the hepatic artery.

Dr. James F. Pingpank from the University of Pittsburgh School of Medicine and a lead Principal Investigator of the Phase III trial presented the data in Chicago on Saturday at the annual meeting of the American Society of Clinical Oncology.

"This clearly shows that you can deliver a much higher dose of chemotherapy and get a tumor response," said Dr. Lynn Schuchter, professor of medicine at the University of Pennsylvania's Abramson Cancer Center.

According to the company, "The Chemosaturation Therapy system is designed to be a repeatable, minimally invasive procedure that isolates the blood flow of the targeted organ, saturates the isolated organ with therapeutic agent, and then filters out toxic levels of the drug before returning to the patient."

But although the system aims to minimize side effects by filtering the drug out of the blood stream as it leaves the liver, some of the drug leaks out. The major side effect seen in the trial was bone marrow suppression.

"We would like to minimize that going forward," said Delcath Chief Executive Officer Eamonn Hobbs.

The system causes "a fair amount of toxicity" and would need to be used only at centers with expertise in monitoring patients, Dr. Schuchter said.

She said two patients (2.5%) died as a result of the treatment.

Delcath has begun a rolling application for its PHP system at the U.S. Food and Drug Administration and expects to complete the package later this year.

Hobbs said Delcath is also exploring ways to use its system in patients with other types of solid tumors in combination with other kinds of chemotherapy drugs.