Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today 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.
"We always expected to see the greatest enrollment activity in the second half of the study period as positive word about the Delcath PHP System spread and attracted new patients to the study," said Eamonn Hobbs, President and CEO of Delcath Systems. "We are delighted to have completed enrollment on-plan, and to continue the extremely positive momentum created over the last six months. 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 Chief Financial Officer and Dr. Krishna Kandarpa as Chief Medical Officer and EVP of Research and Development. We also executed on our plans to build our own manufacturing facility, which we will continue to develop as we focus for the remainder of the year on preparation for our FDA submission, commercialization and international licensing."
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