Reuters Health Information (2010-04-21): Metastatic melanoma trial meets main goal
Drug & Device Development
Metastatic melanoma trial meets main goal
Last Updated: 2010-04-21 20:07:45 -0400 (Reuters Health)
BANGALORE (Reuters) - Delcath Systems Inc said a late-stage study of its experimental anti-cancer technology met the main trial goal of extended progression-free survival in patients with melanoma metastases to the liver.
The company expects to initiate its rolling new drug application submission to the U.S. health regulator within the next 30 days.
The study compared Delcath's Percutaneous Hepatic Perfusion system used with chemotherapy drug melphalan to best alternative care.
Statistical analysis of the trial data showed that patients treated with PHP had a statistically significant longer median hepatic progression-free survival of 214 days compared with 70 days in the best alternative care arm, the company said in a statement.
Delcath's PHP system helps to deliver significantly high doses of chemotherapy drugs to the liver without exposing the patient's entire body to the high toxicity levels of chemotherapy.
It works by first isolating the liver from the patient's bloodstream by means of catheters inserted into blood vessels and then delivering high doses of chemotherapy drugs. The drug-laden blood from the liver is filtered before it is returned to the patient's bloodstream.