Delcath Systems, Inc., (Nasdaq: DCTH) a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, recently sponsored a Satellite Symposium at the World Meeting of Melanoma/Skin Cancer Centers in Berlin, Germany. The session, titled "Regional Therapeutic Options for Metastatic Melanoma," was held on Friday, November 20 and featured updates and observations on a variety of current therapies by clinical leaders in the field.
Dr. Jonathan S. Zager of Moffitt Cancer Center in Tampa, Florida presented an update on the fully enrolled pivotal Phase III Metastatic Melanoma Trial of the Delcath PHP System(TM). Dr. Zager reviewed previously published data and outlined the Phase III trial's demographics, methods and endpoints. The Symposium was very well attended and generated a robust discussion among the participating clinicians.
"The World Meeting of Melanoma/Skin Cancer Centers was an exciting opportunity to contribute to the discussion of regional metastatic melanoma therapies with clinical leaders from around the world," said Jason Rifkin, Delcath's Senior Vice President, Clinical Affairs. "The robust attendance at our Symposium suggests substantial, global anticipation for the PHP System(TM), as clinicians worldwide look for promising therapeutic options for hepatic disease."
The Symposium also featured presentations from Professor John Thompson of the Sydney Melanoma Unit in Sydney, Australia; Professor Alexander M.M. Eggermont of the Erasmus University Medical Center - Daniel den Hoed Cancer Center in Rotterdam, The Netherlands; and Dr. H. Richard Alexander, Jr. of the University of Maryland Marlene and Stewart Greenebaum Cancer Center in Baltimore, Maryland.
The Company announced on October 21, 2009 that the pivotal Phase III Metastatic Melanoma Trial met its goal of 92 patients and is fully enrolled. This clinical study is evaluating 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 PHP System(TM) at the time of disease progression.
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