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Citius Reaches First Interim Analysis Milestone for Mino-Lok® Pivotal Trial
CRANFORD, N.J., Oct. 7, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CRANFORD, N.J., Oct. 7, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\") (\"Company\") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today reported that the data cutoff for the most recent patient treated and completing 8 weeks of observation has been reached. The Company is preparing the submission to the independent Drug Monitoring Committee (\"DMC\") for review and evaluation. \nThe objective of the Phase III pivotal trial for Mino-Lok is to evaluate the efficacy and safety of Mino-Lok in salvaging colonized central venous catheters in subjects with catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) compared to the standard of care using antibiotic locks.\nThe primary endpoint for the trial is the time to a catheter failure event between randomization and the test of cure (TOC).\nThe Mino-Lok protocol is based on reaching 92 catheter failure events for the trial, which corresponds to approximately 144 patients treated in both arms combined.\nThere are 2 interim analyses planned:\nAnalysis of futility will be assessed upon reaching 37 catheter failure events (40% of the total number of anticipated events at approximately 58 patients); and Analysis for superiority will be performed when 69 catheter failure events (75% of the total number of anticipated events at approximately 108 patients).\"We are extremely pleased to have reached this important milestone in the pivotal trial. With the great work performed at such institutions such as MD Anderson Cancer Center, MedStar Georgetown University Hospital, Henry Ford Hospital, Cleveland Clinic, Carolinas Medical Center, and Massachusetts General Hospital, among others, we have been able to progress to our first analysis of the data. There is a huge medical need for a proven antibiotic lock. We are working hard to provide an alternative to submitting a very sick patient to two surgical procedures to remove and possibly replace a tunneled or implanted venous port. We believe that this pivotal trial will be the largest and best controlled clinical trial evaluating catheter salvage in diagnosed CLABSI patients to date. We are doing everything possible to keep the momentum going,\" said Myron Holubiak, Chief Executive Officer of Citius Pharmaceuticals, Inc.\nAbout Citius Ph...