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Delcath Systems Provides Update on Corporate Developments
Date:3/12/2010

g our strategies to gain regulatory approval to market the Delcath PHP System both in the U.S. and in Europe, expand the potential benefits of the Delcath PHP System to patients worldwide and build increasing returns to our shareholders," said Eamonn P. Hobbs, President & CEO.  "Overall, we have made significant progress towards our goals and expect to begin the New Drug Application (NDA) process for FDA approval as soon as practically possible."

"The next operational milestone for our company is the April completion of data analysis from our Phase III trial," said Mr. Hobbs.  "The trial's data analysis involves the initial review by the principal clinical investigators at each enrolling center, an additional review by the Company's retained Clinical Research Organization, and a final review of medical images for verification of results conducted by an independent core lab before final statistical results are compiled by an independent biostatistical group.  We remain highly confident that the trial's data will meet the trial's primary endpoint, and our confidence was recently further buoyed by the FDA's acknowledgement of an expanded access program," added Mr. Hobbs. "Operationally, we are on track to have an inspectable Quality System at our Queensbury manufacturing facility by April, which is a key step in the positioning of the Company for commercialization."

"Our only recent adjustment to our plan has been a revision in our filing
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SOURCE Delcath Systems, Inc.
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3. Delcath Expands Phase III Trial for Metastatic Melanoma to Include St. Lukes Cancer Center
4. Delcath Adds Dr. Pamela R. Contag to Its Board of Directors
5. Delcath Continues Expansion of Clinical Trial Centers Offering PHP(TM)
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