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Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
Date:5/20/2008

NEW YORK, May 20 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH) announced that Richard Taney, President and Chief Executive Officer, provided an update on enrollment numbers in the Company's pivotal Phase III clinical trial today at a gathering of financial and healthcare industry leaders attending the Rodman & Renshaw 5th Annual Global Healthcare Conference.

Mr. Taney's comments updated patient recruitment levels for the Phase III clinical trial of the Company's Percutaneous Hepatic Perfusion (PHP) technology for inoperable cancers in the liver. Enrollment in this pivotal trial, which is treating patients with metastatic melanoma, now totals 32 patients which surpasses one-third of the 92 patients required to complete enrollment of the trial. This represents an acceleration in patient enrollment in this NCI-led multi center trial, and occurs before accrual has begun at the first additional trial site which is the University of Maryland Medical Center.

Although the company is prevented from commenting on results from the randomized Phase III trial, Mr. Taney was able to update the audience on the parallel Phase II trial for patients with metastatic melanoma in the liver who had previously received surgical isolated regional therapy and are therefore ineligible for admission to the pivotal Phase III study. All five of the patients treated in this arm to date have shown responses to PHP and four of the five (80%) have shown objective tumor responses of 30% or greater reduction in tumor size.

Mr. Taney also discussed the metastatic neuroendocrine arm of Delcath's ongoing Phase II trial. This study was the subject of a well-attended presentation during the American Hepato Pancreato Biliary Association Annu
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SOURCE Delcath Systems, Inc.
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