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Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial
CRANFORD, N.J., Aug. 10, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CRANFORD, N.J., Aug. 10, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has reached an important milestone in its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Pending confirmation from an adjudication committee of independent reviewers, the Company believes all 92 events required to complete the trial have been achieved. Several patients remain in active treatment, which may result in additional events.\n\"This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial. As we complete therapy for patients in active treatment, we will continue to enroll patients in the pipeline and initiate shutdown activities,\" stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.\nMino-Lok Phase 3 Trial Design\nThe Mino-Lok Phase 3 pivotal superiority trial (NCT02901717) is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The trial is being conducted in the U.S. and India. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.\nPatients diagnosed with catheter related blood stream infections (CRBSI/CLABSI) and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok therapy or standard of care antibiotic lock therapy.\nPatients in the Mino-Lok arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.\nAbout Mino-Lok\nMino-Lok is an antibiotic lock solution to treat patients with cath...