Citius Achieves 50pc Patient Enrollment in Phase 3 Mino-Lok Pivotal Trial
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itius Pharmaceuticals, Inc. (Citius or the Company) (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical-care drug products, today announced that the Company's lead program, Mino-Lok vs. standard-of-care (SOC) antibiotic locks, has randomized its 72nd patient, thereby passing the halfway point for enrollment in this Phase 3 trial.
The Company previously announced the results of a futility analysis when it passed the threshold of 40% of patients completing end of therapy. That analysis showed a positive outcome, as it met the prespecified interim futility analysis criteria.
The next major milestone in the Mino-Lok trial, expected to be achieved in the first half of 2020, will be the 75% interim analysis for superior efficacy. The endpoints for this analysis require that the time to catheter failure be at least 38 days for Mino-Lok vs. 21 days for SOC antibiotic locks.
We are extremely happy that our trial is proceeding according to plan. The independent drug monitoring committee (DMC) will next evaluate the clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus SOC antibiotic locks, said Myron Holubiak, Chief Executive Officer of Citius.
We believe that the Mino-Lok clinical trial will be a major contribution to the study of catheter-related bloodstream infections (CRBSI) and the utility of antibiotic locks. Effective alternatives are needed to the practice of removing and replacing infected central venous lines.
✔️ Citius Achieves 50pc Patient Enrollment in Phase 3 Mino-Lok Pivotal Trial
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