Mino-Lok™ Phase 3 Clinical Trial Supplies Shipped to Sites

Source:  Citius Pharmaceuticals, Inc.

Mino-Lok recently received Fast Track designation by the FDA 

 Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, has announced that clinical trial supplies of Mino-Lok (minocycline/edetate/ethanol) have been sent to the University of Chicago Medical Center, and the Henry Ford Health System in Detroit, the first 2 clinical trial sites for the Mino-Lok phase 3 pivotal trial. When fully recruited, it is planned that there will be 50 participating sites, all located in the U.S.

The Mino-Lok solution is supplied as: 1) one stoppered glass vial containing lyophilized minocycline powder; and 2) one stoppered glass vial containing a sterile solution of edetate disodium in 25% ethanol. The mixing of the two vials will be prepared via standard pharmacy practices by reconstituting of the lyophilized vial of minocycline using the vial of sterile EDTA/ethanol solution.

Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We have reached a key milestone in advancing this innovative product to an NDA.  Mino-Lok clinical trial supplies have been sent to two of the most prestigious institutions in the US in preparation for the initiation of our phase 3 pivotal trial. We have discussed the urgent need to find an alternative to CVC removal as an approach to treating Catheter Related Blood Stream Infections (CRBSIs).  We are very excited to finally begin our pivotal trial. We believe that the worldwide market potential for Mino-Lok exceeds $1 billion."

There are currently no approved therapies to salvage infected central venous catheters.  CRBSIs are responsible for mortality rates of up to 25% in some patients, and contribute to significant morbidities.

Mino-Lok™ is under investigation and not approved for commercial use.

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.