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Delcath Announces Top-Line Results From Metastatic Colorectal Cohort in Phase II Trial of Chemosaturation System
Date:9/1/2011

NEW YORK, Sept. 1, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) reported top-line results from the metastatic colorectal (adenocarcinoma) cohort of the Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer.  The Company also confirmed plans to initiate a new Phase II single-arm study in the second half of 2012.  The new study is intended to evaluate the efficacy of Delcath's chemosaturation system and its next-generation high efficiency filter in patients with colorectal cancer that is metastatic to the liver and is refractory to first line systemic chemotherapy.

The recently completed Phase II study, conducted at the National Cancer Institute (NCI) in the U.S., included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.  Sixteen patients with very late stage colorectal cancer liver metastases were recruited into this arm.  The predominant accrual of very late stage patients reflects the changing referral and treatment patterns at the NCI at the time that this study was conducted, but it was not a design feature of the study.  No significant responses were noted among these patients as they had been heavily pre-treated with numerous chemotherapeutic and regional modalities that, along with anatomical and disease-related factors in a few, prevented sufficient melphalan exposure. The safety profile of the chemosaturation system was consistent with that previously reported for the Company's Phase 3 melanoma trial.

"While the efficacy signal from this study was inconclusive due to the factors mentioned above, we believe there is solid clinical and scientific justification to conduct a new Phase II trial in a well-defined metastatic colorectal ("mCRC
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SOURCE Delcath Systems, Inc.
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