Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medi...(reach more patients desperately in need ...),Health

Date:4/25/2008

reach more patients desperately in need of new treatment options and expands physician awareness of its potential clinical benefit," said Richard L. Taney, President and CEO of Delcath Systems. "It is especially exciting to be collaborating with Dr. Alexander, who pioneered the use of our PHP system with Melphalan while at the NCI. Throughout 2008, we expect to expand the study to additional clinical sites with world-class clinical oncology programs. Several of these sites are currently in the process of securing the necessary approvals in order to join our clinical trials."

The Phase III Study

The Phase III study is designed to test Delcath's proprietary PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments.

Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath 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 (FDA) under a Special Protocol Assessment (SPA), when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to "cross over" and receive treatment with the Delcath System.

About University of Maryland Medical Center

The University of Maryland Medical Center (UMMC) is the heart of the University of Maryland Medical System's downtown campus. The hospital provides comprehensive care for the West Baltimore community and tertiary care for Maryl
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SOURCE Delcath Systems, Inc. Copyright©2008 PR Newswire. All rights reserved

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