On December 19, 2019 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok vs. standard-of-care antibiotic locks (Press release, Citius Pharmaceuticals, DEC 19, 2019, View Source [SID1234552538]). The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. The market potential for an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and approximately $1.5 billion per year worldwide.

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"We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, the Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."