Peer Reviewed Paper Details Phase I Study At NCI. Plans For Phase II Follow-on At NCI Underway; Phase III Trial with Doxorubicin To Start Enrollment Soon At Sydney Melanoma Unit

STAMFORD, Conn., May 1 -- Delcath Systems, Inc. (Nasdaq: DCTH) announced today that H. Richard Alexander, MD, head of the Surgical Metabolism Section at the Surgery Branch of the National Cancer Institute, will present a paper entitled "A Phase I Feasibility Study Of Hepatic Arterial Melphalan Infusion With Hepatic Venous Hemofiltration Using Percutaneously Placed Catheters In Patients With Unresectable Hepatic Malignancies" at the annual meeting of the American Society of Clinical Oncology (ASCO) May 31-June 2, Chicago. This paper has been reviewed by ASCO peers.

The Phase I dose finding study treated 12 inoperable liver tumor patients with the drug melphalan using Delcath's patented drug delivery technology.

The Delcath system delivers high dose chemotherapy directly to the liver via the hepatic artery. As blood exits the liver, special filters trap the chemotherapy, protecting the rest of the body from excessive toxicity. The procedure is repeatable and less invasive than traditional ways of performing isolated perfusion procedures to effect dose-directed therapy of specific body organs or regions.

The NCI is currently finalizing plans for a Phase II study with melphalan and the Delcath system.

A separate Phase III pivotal trial with the drug doxorubicin is expected to start shortly. The first site for this trial, which will also treat inoperable liver tumors, is the Sydney Melanoma Unit of the Royal Prince Alfred Hospital, Sydney, Australia.

Delcath is a leading developer of isolated perfusion technology for organ or region-specific delivery of therapeutic agents. Its technology is covered by seven US, and three foreign issued patents. The company is headquartered in Stamford, CT.

This release contains "forward-looking statements" based on current expectations but involving known and unknown risks and uncertainties. Actual results or achievements may be materially different from those expressed or implied. Delcath plans and objectives are based on assumptions involving judgments with respect to future economic, competitive and market conditions, its ability to consummate, and the timing of, acquisitions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond its control. Therefore, there can be no assurance than any forward-looking statement will prove to be accurate.

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