Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System
NEW YORK, Aug. 22, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH ) reported encouraging top-line results from the hepatobiliary cohort of the Phase II clinical trial of the Delcath chemosaturation system with melphalan in the treatment of patients with unresectable liver cancer. This study, conducted at the National Cancer Institute (USA), included four patient cohorts: hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal (adenocarcinoma) origins.
There were nine patients with tumors of hepatobiliary origin: five hepatocellular carcinomas (HCC) and four cholangiocarcinomas. HCC is the most common primary cancer of the liver, with approximately 500,000 new cases diagnosed worldwide annually. Both groups had positive efficacy signals. The responses were especially encouraging in the HCC cohort and consisted of confirmed partial response or durable stable disease. The safety profile of the chemosaturation system was consistent with that previously reported for the Company's Phase 3 melanoma trial.
"The disease control and anti-tumor activity seen in the HCC arm of this Phase II study is very encouraging for primary liver cancer patients who currently face limited treatment options," said Eamonn P. Hobbs, President and CEO of Delcath System, Inc. "We believe these results show a strong signal of efficacy, and support our plan to initiate Phase III and Phase IV trials for HCC in the second half of 2012."
Mr. Hobbs added, "We expect to announce additional data from this Phase II trial in the near future, and look forward to presenting detailed results from the metastatic neuroendocrine arm of this trial at the Cardiovascular and Interventional Radiological Society of Europe and European Society for Medical Oncology scientific meetings in September."
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