Citius pharmaceuticals, inc. reaches first interim analysis milestone for mino-lok® pivotal trial

Citius pharmaceuticals, inc. 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. the 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. the primary endpoint for the trial is the time to a catheter failure event between randomization and the test of cure (toc). the 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. there are 2 interim analyses planned: analysis 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).
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