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Data Safety Monitoring Board Unanimously Recommends Continuation of Delcath's Phase III Clinical Trial
Date:9/11/2009

NEW YORK, Sept. 11 -- /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the Data and Safety Monitoring Board ("DSMB") reviewed clinical data on 77 patients enrolled in its pivotal Phase III clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. In addition, the Company announced it now expects enrollment to be completed by mid-October.

Eamonn Hobbs, President and CEO of Delcath Systems stated, "We are pleased by the successful review of our safety data and the recent, accelerated pace of enrollment, which has put us in the trial's home stretch. This is an exciting time for the Company. With current enrollment trends, we now expect to complete enrollment by the middle of October and are still on track for an FDA submission by mid-2010."

The DSMB is an independent group of experts with the responsibility for reviewing and evaluating the safety and response data generated from the Company's Phase III trial. The primary responsibilities of the DSMB are to ensure the safety of all patients enrolled in the trial, the quality of the data collected and the continued scientific validity of the trial design. The DSMB reviews data periodically in order to make an informed risk versus benefit recommendation concerning the continuation, modification, or termination of the trial due to safety concerns. This DSMB review was triggered upon randomization of the 77th patient which marks the 75% enrollment point for the trial.

About the Phase III Study

This clinical study is testing the Delcath PHP Syste
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SOURCE Delcath Systems, Inc.
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