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Citius Achieves 50% Patient Enrollment in Phase 3 Mino-Lok® Pivotal Trial
Next major milestone in Mino-Lok trial is the 75% interim analysis for superior efficacy and is expected in first half of 2020 CRANFORD, N.J., Feb. 4, 2020
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"Next major milestone in Mino-Lok trial is the 75% interim analysis for superior efficacy and is expected in first half of 2020\n\n\nCRANFORD, N.J., Feb. 4, 2020 /PRNewswire/ -- Citius 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. \n\"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.\" \nAbout Mino-Lok® Each year, up to approximately 500,000 central venous catheters of the 7 million used in the U.S. become infected and lead to CRBSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. Mino-Lok is an antibiotic lock solution that is being developed to treat patients with CRBSIs in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and m...