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Delcath Systems, Inc. (DCTH) announced that its pivotal Phase III Metastatic Melanoma Trial has met its goal of 92 patients and is fully enrolled. This clinical study is evaluating the Delcath PHP System(TM) 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(TM) 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.
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