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Citius Pharmaceuticals Reports Positive Results from Recent Data Monitoring Committee Meeting for Mino-Lok Phase 3 Trial
DMC makes recommendation to continue trial with no modifications and requests an ad hoc meeting in near future CRANFORD, N.J., Sept. 29, 2020 /PRNewswire/ --
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"DMC makes recommendation to continue trial with no modifications and requests an ad hoc meeting in near future\n\n\nCRANFORD, N.J., Sept. 29, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that a Data Monitoring Committee (DMC) meeting was held to review the data being generated and analyzed in the Mino-Lok phase 3 trial, and to make recommendations to Citius as to any action that may be necessary regarding the study. \nAfter reviewing these data, the DMC members stated that they did not find any safety signals; and they also recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. \nThe Data Monitoring committee is an independent panel of experts that review progress regarding the safety and efficacy of drugs in clinical trials, and to determine if the trial may be futile in achieving its endpoints or if the trial should be modified in any way. \n\"We are very pleased with the outcome of the DMC's independent review of the Mino-Lok data. This information is very encouraging and supports the confidence that we have long held in the safety and efficacy of Mino-Lok,\" said Myron Holubiak, Chief Executive Officer of Citius. \"Despite challenges in recruiting patients recently due to the COVID-19 pandemic, we have continued to recruit patients and are now approaching the late stage of our pivotal study.\" Holubiak continued, \"I want to thank the DMC committee members for their thoughtful review, and also all of the study investigators and their staff that continue to support our trial in these challenging times.\" \nAbout Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit www.citiuspharma.com.\nAbout Mino-Lok®Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy thr...