Healthcare Industry News:  CRBSI  


 News Release - July 18, 2016

Citius Pharmaceuticals Completes Feasibility Study of Investigator Sites for Mino-Lok(TM) Phase 3 Trials

CRANFORD, N.J., July 18, 2016 -- (Healthcare Sales & Marketing Network) -- 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.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Source: Citius Pharmaceuticals

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