Delcath Announces Preliminary Safety Analysis for Phase 3 Focus Trial
Delcath Systems, Inc. (DCTH)
US:NASDAQ Investor Relations:
delcath.com/investors
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Source: GlobeNewswire
NEW YORK, Dec. 19, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma has completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. The FOCUS Trial is evaluating the efficacy, safety and pharmacokinetics of Melphalan/HDS versus best alternative standard of care in 240 patients with metastatic ocular melanoma (OM). The primary objective of the study is a comparison of overall survival between the Melphalan/HDS treatment arm and best alternative care arm comprised of selected therapies; secondary objectives include overall progression-free survival and objective response rate, each as determined by the Investigator, while
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