- Citius Pharmaceuticals Inc CTXR announced that the subsequent planned interim analysis for its Phase 3 trial of Mino-Lok for catheter-related bloodstream infections had been scheduled for the end of June.
- Per the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority, and futility.
- According to the Mino-Lok Phase 3 study protocol, the DMC is responsible for conducting interim analyses when 40%, 50%, and 65% of the total number of anticipated events have been observed.
- The Phase 3 pivotal superiority trial is designed to determine the efficacy and safety of Mino-Lok (MLT), an antibiotic lock therapy that combines minocycline with edetate disodium.
- The primary endpoint for this study is the time to a catheter failure event.
- To date, the Company has achieved more than 80% of the expected enrollment.
- Price Action: CTXR shares are down 2.75% at $2.48 during the market session on the last check Tuesday.
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