Delcath Expands Phase III Trial For Metastatic Melanoma To Include St. Luke's Cancer Center

Main Category: Dermatology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 04 Jun 2008 - 2:00 PDT

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Delcath Systems, Inc. (Nasdaq: DCTH) announced that the St. Luke's Cancer Center of Bethlehem, PA, part of St. Luke's Hospital & Health Network (St. Luke's), has joined Delcath's Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver using the Company's Percutaneous Hepatic Perfusion (PHP) System for the isolated, high dose delivery of the anti-cancer agent melphalan. This Phase III multi-center study is led by the National Cancer Institute (NCI) and is enrolling at cancer centers throughout the United States.

Delcath has finalized a clinical research agreement with St. Luke's. Sanjiv Agarwala, M.D., Chief of Oncology and Hematology, will serve as the Principal Investigator of the study at St. Luke's. Dr. Agarwala, a leader in the field of melanoma and clinical oncology, commented, "Metastatic melanoma in the liver presents a devastating cancer with no effective treatment options. We are very pleased to be able to provide this option to patients suffering from this disease. This is a study with tremendous potential to treat patients with aggressive disease burden and is a promising advance in the field of liver directed regional therapy."

"The addition of St. Luke's and Dr. Agarwala to this trial, which follows the recent announcement that the University of Maryland will commence enrollment of patients, is expected to be followed by the announcement of additional centers during the summer. Delcath continues to expand this Phase III study to leading cancer centers and we welcome this collaboration with St. Luke's, as it further allows the Delcath PHP System to reach patients who can benefit from this treatment option," said Richard L. Taney, President 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., Europe, Asia and Canada. For more information, please visit the Company's website at http://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 Phase III 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.

Delcath Systems, Inc.
http://www.delcath.com