Yes, from 240 to 200 patients only!
NEW YORK, Dec. 19, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (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 exploratory objectives include progression-free survival, objective response rate, hepatic progression free survival and hepatic objective response rate all as determined by blinded Independent Central Review, and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.
“The DSMB’s recommendation to proceed without modification with the FOCUS Trial as planned confirms our own observations of the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. “Importantly, this initial independent evaluation of the safety profile of melphalan/HDS used the Generation Two filter configuration of the device and the current version of the procedure protocol, and so provides confidence in both our product and procedure. Given that safety concerns with the previous generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased to have successfully passed this important milestone.
In My Own Personal Opinion Of Course!
