Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that it 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.
"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 (PHP(TM)) technology is a compelling proposition," said Eamonn Hobbs, President and CEO of Delcath Systems. "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."
About the Phase III Study
This clinical study is testing the Delcath PHP System(TM) 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 Delcath PHP System(TM) is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while minimizing entry of the drugs into the rest of the patient's circulation. This isolation limits toxicities which result from systemic chemotherapy treatments.
Patients in the Phase III trial are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP System(TM) or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by U.S. Food and Drug Administration under a Special Protocol Assessment (SPA), patients are permitted to "cross-over" from the best alternative care arm to receive treatment with the Delcath System at the time of disease progression.
The Source: http://www.delcath.com