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This clinical study is evaluating the Delcath PHP system for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver.
With the achievement of complete enrollment, the company remains on-track for a FDA submission of its Delcath PHP system with melphalan in 2010. Trial enrollment will continue for the near-term to include additional patients that have begun the evaluation process and may be eligible to participate.
The Delcath PHP system is designed to deliver significantly higher doses of anticancer drugs to a patient's liver while minimizing entry of the drugs into the rest of the patient's circulation. This isolation limits toxicities which result from systemic chemotherapy treatments, Delcath said.
Patients in the Phase III trial are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath PHP system or treatment with best alternative care.
The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by FDA under a special protocol assessment, patients are permitted to 'cross-over' from the best alternative care arm to receive treatment with the Delcath System at the time of disease progression.
Eamonn Hobbs, president and CEO of Delcath Systems, said: "We have achieved several key, strategic milestones, including the successful review of our Phase III safety data, orphan drug designation for doxorubicin for the treatment of hepatocellular carcinoma, and the additions of David McDonald as CFO and Krishna Kandarpa as chief medical officer and executive vice president of R&D.
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