Citius Pharmaceuticals Reports Strong Clinical Community Engagement During Mino-Lok® Phase 3 Trial-Related Webinar
CRANFORD, N.J., April 29, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc., ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced updates delivered during its third Mino-Lok® Phase 3 trial-related webinar. Mino-Lok®, the Company's lead product candidate, is an antibiotic lock therapy designed to salvage central venous catheters (CVCs) in patients with catheter related bloodstream infections (CRBSIs) or central line associated blood stream infections (CLABSIs). The webinar, led by Dr. Alan Lader, PhD, Vice President of Clinical Operations at Citius Pharmaceuticals was attended by investigators, clinical trial staff and referring physicians from trial sites participating in the Mino-Lok Phase 3 clinical trial.
"We are encouraged to see strong and growing interest within the clinical community in Mino-Lok as a potential treatment option for patients with CRBSI/CLABSI. There are currently no FDA approved therapies to salvage infected CVCs," stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Pharmaceuticals.
"We believe Mino-Lok has the potential to become the gold standard in CRBSI/CLABSI care, and the first and only FDA approved treatment option for salvaging catheters in patients with CRBSI/CLABSI," added Myron Holubiak, President and Chief Executive Officer.
"Today, the standard of care for patients with CRBSI/CLABSI is to remove and replace a CVC. By penetrating the biofilm, breaking down bacterial colonies and eradicating the bacteria, Mino-Lok's proprietary formulation has the potential to allow healthcare providers to salvage indwelling vascular catheters rather than replace them. This was our most well-attended webinar to date, which we believe is an indication of the importance of the work we are doing to address a critical unmet need in salvaging infected central lines," concluded Dr. Lader.
The webinar agenda included a review of the formation of catheter biofilm, CLABSI treatment challenges with biofilm, pathogen responses to specific antimicrobials, and the benefits of Mino-Lok in addressing biofilm and CLABSI challenges.
Central venous catheters (CVCs) are life-saving vascular access ports in patients requiring long-term intravenous therapy. CVCs are used to administer fluids, blood products, nutritional solutions, and medication, as well as for hemodynamic monitoring. While CVCs are important in treating many conditions, particularly in intensive care units, they pose a significant risk for device-related infections, and are a leading cause of morbidity and mortality. Of the approximately 7 million CVCs used annually in the US, about 500,000, or 7%, become infected, leading to serious, life-threatening infections called catheter-related bloodstream infections (CRBSIs).
It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria in the CVC, and there are currently no approved therapies for salvaging infected central venous catheters. The standard of care in the management of CRBSIs consists of removing the infected CVC and replacing it with a new catheter at a different vascular access site. These procedures are costly, and 15% to 20% of the procedures are associated with significant morbidity.
Mino-Lok is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). There are currently no approved therapies for salvaging infected CVCs. Mino-Lok is used 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 is currently enrolling subjects in its Phase 3 clinical trial. The U.S. Food and Drug Administration (FDA) granted Mino-Lok Qualified Infectious Disease (QDIP) and Fast Track designation.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapy. The Company's lead product candidate, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal superiority trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. 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," "plan," "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: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates, including Mino-Lok®, and the risk of regulatory approval; the estimated markets for our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to attract, integrate, and retain key personnel; 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; government regulation; 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.
Company Codes: NASDAQ-SMALL:CTXR