Wednesday, November 1, 2017

Citius Pharmaceuticals, Inc. Provides Phase 3 Update On Mino-Lok™ Clinical Trial Following FDA Meeting






Source:  Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today it has received feedback from the U. S. Food and Drug Administration regarding amendments to the phase 3 study plan for Mino-Lok™, an adjunctive treatment for catheter related blood stream infection. There are currently no approved therapies to salvage infected central venous catheters ("CVCs").  Citius is currently recruiting sites for a phase 3 trial of Mino-Lok in the United States.

The FDA stated that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the Company's concerns and would be acceptable. They also reinforced their commitment to work with the Company to revise the trial design to meet the requirements of a new drug application.

Following the discussion with the FDA, Citius amended the phase 3 study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today's current standard of care. The Company also noted that the dwell times and dosing schedules of the antibiotic lock therapy ("ALT") active control arm would be changed because there is an extreme level of variability and heterogeneity in how ALTs are dosed and used today.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We are extremely pleased to work closely with the FDA to design a trial that meets today's need for better information and evidence as it relates to the treatment of infected CVCs and dosing schedules for ALTs.  Experts agree that there is a great deal of variability allowed in the Infectious Disease Society of America (IDSA) guidelines with respect to the antibiotic chosen and the dwell times used for ALT's.  We are confident that we will be able to demonstrate the superiority of our ready-to-use Mino-Lok over hospital compounded antibiotic solutions for which there have not been any largescale controlled studies or data driven evidence."  

About Citius Pharmaceuticals, Inc.
Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care and unique prescription products that use innovative, patented or proprietary formulations of previously-approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs; by using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.



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