Citius Pharmaceuticals, Inc., a specialty pharmaceutical company, has initiated manufacturing for the company's clinical trial of Mino-Lok, an antibiotic lock solution used to salvage central venous catheters (CVCs) and to treat catheter related bloodstream infections (CRBSIs).

Citius Pharmaceuticals has engaged two large contract-manufacturing organizations (CMOs) to perform the work.  The product will be manufactured and packaged in two components, to be mixed and used at patient treatment sites.  Minocycline will be manufactured by one of the largest CMOs with global operations.  The other two components will be packaged at a US-based CMO with expertise in this area.  The work has commenced at both locations and the company expects the materials to be available for clinical use when the first patient is enrolled in early 2017.

Myron Holubiak, president and CEO stated, "Manufacturing of the components of Mino-Lok for clinical trial purposes marks a significant milestone for Citius.  We hope to prove that a simple administration protocol that conforms to everyday work process in hospitals today will be able to salvage infected CVCs that cause devastating bacteremias in very vulnerable patients.  There is currently no other solution on the market or in development that is focused on catheter salvage.  We are confident that a successful trial will help to establish Citius as a market leader in the industry and allow us to offer an attractive alternative to removing and replacing central lines in very ill and susceptible patients.

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 nearly 500,000 of those result in CRBSIs leading 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 it 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 antibiotics(s), to preserve venous access and avoid the complications of morbidities associated with catheter removal and reinsertion.  Mino-Lok penetrates biofilm, eradicates bacteria and provides anti-clotting properties to salvage infected indwelling CVCs.

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.