On August 23, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 clinical 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 (Press release, Delcath Systems, AUG 23, 2018, View Source;p=RssLanding&cat=news&id=2364655 [SID1234529753]). This review was conducted on data collected from the prior randomized protocol for the FOCUS Trial. The DSMB again recommended that no safety related modifications to the treatment protocol be made.
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In July, the Company announced that it has amended the protocol for the FOCUS trial, which will now enroll as a single-arm, multi-center open label study. Safety data to be collected were not 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 to the Food & Drug Administration as part of a New Drug Application. The FOCUS trial, now entitled A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), will enroll a minimum of 80 patients with ocular melanoma metastatic to the liver. Patients previously enrolled under the prior randomized protocol will continue to be treated and evaluated as part of the amended trial, and periodic DSMB reviews will continue to be conducted.
"The safety data in the Melphalan/HDS arm of the prior randomized protocol of the FOCUS trial has been consistent with that observed in recent research in a non-clinical setting," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "Given that safety concerns with the prior generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased with the safety profile observed by our therapy in the trial thus far."