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Delcath Systems Reports Substantial Progress
Date:11/19/2009

ng 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.
  • Enrollment in the Phase II clinical study of the Delcath PHP System with melphalan for patients with inoperable liver metastases from neuroendocrine tumors has now reached 25 patients. The trial is continuing to enroll patients. The multi-arm trial is being conducted by the National Cancer Institute ("NCI") in Bethesda, Maryland. The trial is also enrolling patients suffering from primary liver cancer and metastatic adenocarcinomas (including colorectal cancer) and melanoma. The Company expects to update data from this study in the coming months.
  • Completed the expansion of the executive management team with the additions of David McDonald, Chief Financial Officer; Dr. Krishna Kandarpa, Chief Medical Officer and Executive Vice President of Research and Development; Agustin Gago, Executive Vice President for Global Sales and Marketing; John Purpura as Executive Vice President for Regulatory Affairs and Quality Assurance; and Armand "Chuck" Frigon as Vice President for Operations.
  • Established a low cost operations facility in Queensbury, New York in which Delcath plans to locate manufacturing of its PHP System.
  • "With the enrollment in our Phase III clinical study completed, we are now beginning to prepare our application to the FDA for marketing approval," said Mr. Hobbs. "We continue to expect that we will submit the application to the FDA by the end of the first half of 2010. Meanwhile, we are optimistic about our ability to gain CE mark approval in Europe in early 2010 and expect to begin commercial sales in the European markets shortly thereafter. With the proceeds from the offering boosting our cash balance to more than $37 million, and the potential opportunity to gain additional resources through international partnerships, we are v
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    SOURCE Delcath Systems, Inc.
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