Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that Dr. James F. Pingpank, Associate Professor of Surgery for the University of Pittsburgh School of Medicine will present an abstract at the International Liver Cancer Association’s (ILCA) Third Annual Conference on Saturday, September 5, 2009 in Milan, Italy. Dr. Pingpank’s poster is titled, “Percutaneous hepatic perfusion (PHP) with melphalan for patients with unresectable hepatic metastases from ocular and cutaneous melanomas.”
Eamonn Hobbs, President and CEO of Delcath Systems stated, “ILCA is an excellent forum for Delcath to increase the medical communities’ awareness of the Delcath PHP System(TM) as we move towards full enrollment of our pivotal Phase III study. Our presence is important as we prepare for commercialization and introduce our PHP System(TM) to European physicians, surgeons and medical oncologists. Participation also allows us further insight into current marketing and selling initiatives abroad.”
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.