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Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System
Date:8/22/2011

bjectives were to determine the response rate and duration of response to intrahepatic infusion of melphalan with subsequent venous hemofiltration.  Secondary objective measures included patterns of recurrence, progression-free survival and overall survival.  Additional secondary objectives were to evaluate safety and tolerability in this patient population, and assess filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors.

About Hepatocellular CarcinomasHepatocellular carcinoma (HCC) is a primary cancer of the liver and one of the most deadly forms of cancer. HCC ranks as the fifth most common solid tumor cancer, with an annual incidence of approximately 20,000 cases per year in the United States, approximately 40,000 cases per year in Europe and approximately 500,000 cases per year worldwide, due to the high prevalence of Hepatitis B and C in developing countries. Usually seen in people aged 50 – 60, this type of cancer occurs more often in men than women. Treatment options of HCC and prognosis are dependent on many factors including tumor size and location, the underlying functional capacity of the liver, and the stage of the disease. High-grade tumors will have a poor prognosis, while low-grade tumors may go unnoticed for many years. Hepatocellular carcinoma is potentially curable by surgical resection, but surgery is the treatment of choice for only the small fraction of patients with localized disease. The usual outcome is poor, because only 10-20% of HCC can be removed completely using surgery. If the cancer cannot be completely removed, the disease is usually deadly within 6 months.

About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased
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