Delcath Expands Phase II Multi-Histology Clinical Trial.

New Arm to Treat Relapsed Melanoma Patients Previously Shown to Respond to Isolated Hepatic Perfusion 

STAMFORD, Conn. -- Delcath Systems, Inc. (Nasdaq:DCTH) announces the expansion of the Company's Phase II multi-histology clinical trial to include a fourth arm consisting of patients with metastatic melanoma in the liver who have previously received isolated hepatic perfusion (IHP), but whose cancer has since relapsed. The Phase II clinical trial, which is ongoing at the National Cancer Institute (NCI), is testing use of the Delcath System for the organ-specific delivery of the chemotherapeutic agent, melphalan, in patients with specific tumors in the liver, including primary liver cancer, metastatic neuroendocrine tumors and adenocarcinomas in the liver.

The Delcath System is used to perform percutaneous hepatic perfusion (PHP), which utilizes a series of catheters and an external blood filtration apparatus to deliver high doses of chemotherapeutic agents to a tumorous liver while significantly removing the toxic drugs from the patient's blood, thus restricting its systemic circulation throughout the patient where it would cause unacceptable and possibly fatal side effects.

The added arm of the trial, which is independent of the other arms, allows Delcath to assess the impact of PHP therapy on patients who previously responded to high-dose melphalan, but later experienced a relapse with one or more tumors growing back. Patients who previously responded to the therapy are considered good candidates to respond again, and patients with prior PHP or IHP treatment in the Phase I trial had additional responses and prolonged survival times.

"We expect that data from the new arm of this trial will demonstrate the clinical value of multiple courses of organ-specific delivery of high-dose chemotherapy with the Delcath device. Adding this fourth arm was made specifically at the request of the clinicians and is further recognition that there are no proven treatment alternatives for these patients," said Richard L. Taney, Chief Executive Officer of Delcath Systems.

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 12 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.

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.