Citius Pharmaceuticals Announces Publication in Antimicrobial Agents and Chemotherapy Journal of Positive Preclinical Results for Mino-Lok® in Rapidly Eradicating Candida Auris
March 2020 issue of AAC journal highlights in vitro study at MD Anderson Cancer Center Labs that shows Mino-Lok to be effective in completely eradicating all ten strains of Candida auris tested
CRANFORD, N.J., March 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today the publication of an in vitro study for Mino-Lok®, the Company's antibiotic lock solution used to treat patients with central line associated blood stream infections (CLABSIs) and catheter-related bloodstream infections (CRBSIs), in the March 2020 issue of Antimicrobial Agents and Chemotherapy. The article, titled "Minocycline-EDTA-Ethanol Antimicrobial Catheter Lock Solution Is Highly Effective In Vitro for Eradication of Candida auris Biofilms," highlights the in vitro efficacy of Mino-Lok against various strains of Candida auris ("C. auris") from studies conducted at MD Anderson Cancer Center Labs.
Mr. Myron Holubiak, Chief Executive Officer of Citius, said, "We're happy to have the positive preclinical results of Mino-Lok published in the AAC Journal. Candida auris is a very problematic type of fungus, but the results from these in vitro studies showed that complete eradication of all strains of C. auris occurred within an hour of exposure to Mino-Lok. We anticipate completing our Phase 3 trial with Mino-Lok by the end of 2020, which will bring us one step closer to treating patients with infected catheters from any number of fungi or bacteria."
C. auris is a fungus that can cause serious bloodstream infections or death, particularly in hospital and nursing home patients with serious medical problems. More than one in three patients with invasive C. auris infection die. The fungus is often resistant to most antifungal agents commonly used to treat Candida infections. Although C. auris was just recently discovered in 2009, it has spread quickly and caused infections in more than a dozen countries. Patients who have been hospitalized in a healthcare facility a long time, have a central venous catheter or other lines or tubes entering their body, or have previously received antibiotics or antifungal medications, appear to be at highest risk of infection with this yeast.
Each year, more than 330,000 central venous catheters out of the 7 million used in the U.S. become infected and lead to CRBSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. Mino-Lok is an antibiotic lock solution that is being developed to treat patients with CRBSIs in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok penetrates biofilm, eradicates bacteria and salvages infected, indwelling vascular catheters while providing anticlotting properties. Mino-Lok has the potential to change the standard of care for the management of these serious infections.
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.
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 associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment and achieving the required number of catheter failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial additional funds; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical results and our ability to file an IND; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; 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 attract, integrate, and retain key personnel; 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.
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SOURCE Citius Pharmaceuticals, Inc.
Released March 26, 2020