Delcath Phase III Trial Results Exceed Primary Endpoint Expectations

Treatment Arm Shows More Than 3x Median hPFS Compared to Control Arm

New York, NY -- April 21, 2010 -- Delcath Systems, Inc. (NASDAQ: DCTH), a development stage, oncology-focused, specialty pharmaceutical and medical device company, announced that its Phase III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study’s primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis. Comparing treatment with the Delcath PHP System™ with melphalan to Best Alternative Care (BAC), based on independent core lab review of patient scans, the statistical analysis revealed that the PHP patients had a statistically significant longer median hPFS of 214 days compared to 70 days in the BAC arm (p=0.001). This reflects a 144-day prolongation of hPFS over that of BAC control arm, with less than half the risk of progression and/or death in the PHP group compared to the BAC group (Hazard Ratio = 0.46).

http://delcath.com/index.php/news/171-delcath-phase-iii-trial-results-exceed-primary-endpoint-expectations.html