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Delcath Expands Phase III Trial for Metastatic Melanoma to Include St. Luke's Cancer Center
Date:6/3/2008

resident and CEO of Delcath Systems. "We plan to continue expanding this trial to centers throughout the United States and broadening the availability of the technology."

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 PHP 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 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 (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 PHP System. The Phase III study, which recently exceeded 33% enrollment, is expected to be completed in 2009, leading to an application to the US Food and Drug Administration (FDA) for commercial approval of the Delcath PHP System.

About Delcath Systems, Inc.

Delcath Systems is a developmental stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents. The Delcath PHP System is currently being tested with the drug melphalan in Phase III and Phase II clinical trials. The Company's intellectual property portfolio currently consists of twenty-eight patents on a worldwide basis including the U.S
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SOURCE Delcath Systems, Inc.
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