NEW YORK, Nov. 24 /PRNewswire-FirstCall/ -- Delcath Systems, Inc., (Nasdaq: DCTH) a medical technology company
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™. 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™, 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™ 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™ 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™ 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™ at the time of disease progression.
About Delcath Systems, Inc.
Delcath Systems Inc. is a medical device company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete our clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
SOURCE Delcath Systems, Inc.
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