Delcath Systems Exceeds 90% Enrollment For Phase III Metastatic Melanoma Trial

Delcath Systems, a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, has exceeded 90% enrollment (reaching 85 patients) for its pivotal phase III Metastatic Melanoma Trial. Based on trial specifications, the company needs 92 for enrollment achievement.

The company said that this clinical study is testing the Delcath PHP System for the regional delivery of melphalan to the liver, to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver.

The company claims that the Delcath PHP System is designed to deliver doses of anti-cancer drugs to a patient’s liver, while minimizing entry of the drugs into the rest of the patient’s circulation.

Reportedly, patients in the phase III trial are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP System or treatment with best alternative care.

The company said that the study is designed to evaluate the duration of tumor response in each of the two study arms.

Eamonn Hobbs, president and CEO of Delcath Systems, said: We are pleased to report this important patient enrollment milestone. Our success validates the need for a drug delivery platform that is unique in the interventional oncology arena. With approximately 250,000 cases of primary or secondary cancer of the liver diagnosed each year in the U.S. and 2.6 million cases globally, we believe our Percutaneous Hepatic Perfusion technology is a compelling proposition.

“Our next milestone will be a successful review of safety data in early September in preparation for a FDA submission by mid-2010, as well as CE Mark approval, which would allow for marketing outside the U.S.A. by June 2010, he added.