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Positive Phase 2 Trial Results from Neuroendocrine Tumor Cohort Presented at CIRSE
Date:9/13/2011

NEW YORK and MUNICH, September 13, 2011 /PRNewswire/ --


Chemosaturation Demonstrates Clinically Meaningful Tumor Response with Unresectable Neuroendocrine Tumors in the Liver  

Delcath Systems, Inc. (NASDAQ: DCTH) announced that updated results from the metastatic neuroendocrine tumor (mNET) cohort of the Company's recently completed Phase 2 clinical trial were presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress held this week in Munich, Germany. James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a Principal Investigator of the Phase 2 trial, presented the late-breaking abstract on September 12, 2011at 4:45pm during an Oncologic Intervention oral abstract session.

In the Phase 2 trial's mNET cohort, 24 patients with unresectable mNET in the liver underwent an average of 3 chemosaturation procedures with concentrated melphalan and subsequent extra-corporeal venous hemofiltration. The primary endpoint of overall hepatic response rate (ORR) among the 20 evaluable patients was 70%, including one patient who presented with a confirmed complete response (CR) and 13 with confirmed partial responses (PR). Four patients had stable disease (SD) and 2 progressed at their first evaluation, giving a tumor growth control rate of 90%. As for secondary endpoints, the median overall survival in all 24 patients (on an intent to treat or ITT basis) was reported as 30.4. months. The safety profile of the chemosaturation system was consistent with that previously reported for the Company's Phase 3 melanoma trial.

"Currently available treatment options for patients with unresectable neuroendocrine liver metastases have response rates around 5%. The anti-tumor activity and duration of response seen in the mNET arm of this Phase 2 study is very po
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SOURCE Delcath Systems, Inc.
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