Citius Pharmaceuticals Completes Feasibility Study of Investigator Sites for Mino-Lok™ Phase 3 Trials
The Company's Antibiotic Lock Therapy Treats Catheter-related Blood Stream Infections (CRBSIs); Phase 3 Trial Expected to Commence Q1 2017
CRANFORD, N.J., July 18, 2016 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (OTC BB: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today that it has completed a feasibility study of major academic sites with respect to conducting phase 3 trials for its Mino-Lok™ product. Mino-Lok™ is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections ("CRBSIs") and is anticipated to start phase 3 trials early in the first quarter of 2017. Phase 3 trials are expected to be completed within two years after the program starts.
Central venous catheters (CVCs) are life-saving vascular access ports in many patients requiring long-term intravenous therapy. Approximately 7 million CVCs are used annually and about 500,000 of those result in CRBSIs leading to serious, life threatening infections and morbidities. Currently, the treatment for patients with a CRBSI is to treat the bacteremia with appropriate systemic antibiotic therapy and in most cases remove the infected CVC and replace with a new CVC at a new venous access site. There are currently no approved therapies to salvage infected CVCs. Mino-Lok™ is an antibiotic lock solution that will be studied to treat patients with CRBSIs in combination with appropriate systemic antibiotic(s), to preserve venous access and avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok™ penetrates biofilm, eradicates bacteria and provides anti-clotting properties to salvage infected indwelling CVCs.
Myron Holubiak, CEO of Citius commented, "We believe that catheter salvage with a proven antibiotic lock therapy would be an important clinical advance, and provide clinicians with an attractive alternative to removing and replacing infected CVCs. Our survey of major academic centers indicates that there is great interest in studying Mino-Lok™ for this purpose, and that there is a significant need for a well-controlled trial to provide objective data in this regard. Our team is excited to be advancing Mino-Lok™ through the development process towards commercialization."
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 using 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. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.
Released July 18, 2016