Citius' Mino-Lok™ Addresses Resistant Pathogens

Many CRBSI Pathogens are Resistant to Many Antibiotics

CRANFORD, N.J., Jan. 11, 2017 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") (OTC BB: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, said today that the phase 3 study of Mino-Lok™ treatment of infected central venous catheters (CVCs) will include the most common organisms that are associated with catheter related blood stream infections (CRBSIs), and that many of these pathogens have been shown to be resistant to many of the antibiotics being used today. Mino-Lok is being developed as an adjunctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI) in combination with appropriate systemic antibiotic(s), to salvage infected central venous catheters (CVCs), to preserve central venous access, and to avoid the complications and morbidities associated with catheter removal and reinsertion.

Mr. Myron Holubiak, President and CEO stated, "There has been an alarming growth of antibiotic resistance in hospital acquired infections. The CDC has designated carbapenem-resistant Enterobacteriaceae (CRE) as being an 'Urgent Threat' meaning that these infections are untreatable or hard-to-treat, and are on the rise in medical facilities. CREs have become resistant to all or nearly all of the antibiotics we have today, and almost half of CRE bacteremic hospital patients will die from their infection.

Additionally, CDC considers Methicillin Resistant Staphylococcus aureus (MRSA) to be a 'Serious Threat.' MRSA causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death.  Staph bacteria, including MRSA, are one of the most common causes of healthcare-associated infections. 

We were encouraged by the work performed by the MD Anderson Cancer Center that showed Mino-Lok to be highly effective in vitro against these highly virulent organisms that form biofilm to protect their colonies from antibiotic attack. We have designed our phase 3 study to assure that these virulent and resistant pathogens are included, and we expect that Mino-Lok therapy will be effective in salvaging the CVCs in these settings." 

There are currently no approved therapies to salvage infected CVCs. 

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 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. 

Andrew Scott
Vice President, Corporate Development
(O) 908-967-6676

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SOURCE Citius Pharmaceuticals, Inc.