Delcath Announces 4th Independent Safety Review of Registration Trial Data for Metastatic Ocular Melanoma: Recommended Continuation with no Trial Modification
Delcath Systems, Inc. (DCTH)
US:NASDAQ Investor Relations:
delcath.com/investors
Company Research
Source: GlobeNewswire
NEW YORK, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the independent Data Safety Monitoring Board (DSMB) of the Registration trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial) completed another pre-specified review of safety data for treated patients in the trial. This review was conducted on data collected from both the prior randomized protocol and the amended single-arm protocol for the FOCUS Trial. The DSMB again recommended continuation of the study without modification. In July, the Company announced that it has amended the protocol for the FOCUS trial, which is now enrolling as a single-arm, multi-center open label study. Safety data collected have not been modified as a result of the amendment, and safety data from both the randomized and single-arm protocols will be pooled in any analyses submitted t
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