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Delcath Treatment for Liver Cancer is ''Featured Clinical Trial'' in Latest National Cancer Institute (NCI) Cancer Bulletin

Posted on: Thursday, 11 October 2007, 12:00 CDT

Delcath Systems, Inc. (Nasdaq:DCTH) announced today that the Company's Phase III study is the "Featured Clinical Trial" in the October 9th edition of the NCI Cancer Bulletin (Volume 4/Number 27).

Delcath's pivotal Phase III trial was approved under a Fast Track designation from the U.S. Food and Drug Administration (FDA), following its advancement directly from Phase I. This clinical trial is being conducted under a Special Protocol Assessment with the FDA. Delcath previously announced that the Company expects several sites to be added to the trial before year-end, with the NCI having agreed to act as the lead center in the trial.

Richard Taney, President and CEO of Delcath Systems, commented, "We are delighted to gain this visibility for our technology platform from the NCI Cancer Bulletin. We are optimistic that efforts to accelerate patient enrollment and expand physician awareness ultimately will benefit patients with liver cancer and their families as we move closer to submitting the Delcath System to the FDA for approval."

As reported earlier this year, the NCI presented interim results from one of several Phase II trials using the Delcath System. This data revealed objective tumor responses, including complete and partial responses, in 77% of patients treated using the Delcath System. The remaining 23% of patients were classified with stable disease. The study's Principal Investigator, Dr. James Pingpank also reported survival data within a range of 14 to 42 months for these patients.

In the NCI Cancer Bulletin article, Dr. Pingpank states, "With this study, we're comparing treatment with systemic chemotherapy versus a minimally invasive method of delivering chemotherapy regionally to the affected organ. We hope to establish regional chemotherapy as a standard of care for patients with metastatic ocular melanoma, a disease for which no standard therapy exists."

The NCI Cancer Bulletin is available at: http://www.cancer.gov/NCICancerBulletin/NCI_Cancer_Bulletin_100907 .pdf?cb_em (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)

The "Featured Clinical Trial" is on page 8.

About Delcath Systems, Inc.

Delcath Systems is the developer of percutaneous perfusion technology for organ- or region-specific delivery of therapeutic and chemotherapeutic agents. The Delcath System is currently being tested with the drug Melphalan in a Phase III trial of patients with metastatic ocular and cutaneous melanoma in the liver, and a Phase II trial of patients with primary liver cancers and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion. The Company's intellectual property portfolio currently consists of 18 patents on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website 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.

Source: Business Wire

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