Citius Holds Webinar Series on Conducting Mino-Lok Phase 3 Trial During COVID-19
- Infectious Disease experts provide review of CLABSI patient management in a restricted environment
- CLABSI case histories reviewed and discussed
CRANFORD, N.J., Dec. 15, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has conducted a series of webinars to provide trial updates, discuss patient identification parameters, the challenges of running a trial in today's Covid-19 environment, and the role Mino-Lok may play in the treatment of Central Line Associated Blood Stream Infections (CLABSIs). Presentations were made by infectious disease experts from The University of Texas MD Anderson Cancer Center and Alan Lader, PhD, VP of Clinical Operations at Citius Pharmaceuticals provided a status report of the phase 3 trial which is now beyond its halfway point.
Participating in the webinar were 18 clinical trial sites and 30 investigators or site staff from the following institutions:
Anne Arundel Medical Center
Ascension Via Christi Hospital
Carolinas Medical Center
Edward Hines Jr VA Hospital
Indiana Blood and Marrow Transplant
Lutheran Hospital in Illinois
Manati Medical Center
Ponce Research Institute
Salem VA Medical Center
University Hospitals Cleveland Medical Center
University of Florida
University of Kentucky
University of Massachusetts Memorial Medical Center
University of New Mexico
VA Caribbean Healthcare System
VA Sierra Nevada Health Care System
A few key topics on the agenda included a review of the pathogens encountered to date, the benefits of Mino-Lok for a CLABSI patient with a mucosal barrier injury, the frequency of unnecessary removal of non-colonized CVCs in suspected CLABSI patients with bacteremia, how to handle patients with multiple catheters (case history), and the path forward for study completion.
"Currently, the primary treatment for patients who become bacteremic because of the central lines being infected is to treat the patient aggressively with culture-directed antibiotics and to remove the central line which is believed to be the source of the infection and replaced when the patient's status improves. Patients and physicians need an effective and less invasive alternative to catheter exchange which utilizes much of the same set of resources needed to treat Covid-19 patients, especially in the ICU. We have been fortunate to be able to persevere in continuing this study in a challenging time, and we are hopeful to provide objective evidence that antibiotic locks can work, and become a viable alternative to remove and replace. Mino-Lok will be the first, and most extensively studied, antibiotic lock for salvaging catheters in patients with CLABSI," said Myron Holubiak, President and CEO. "We initially held one webinar, but after receiving very positive feedback, we have decided to expand into a series of webinars," Holubiak continued. "This once again affirms there is definitely an unmet need and with that a great deal of interest in salvaging infected central lines."
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 and cancer care. For more information, please visit www.citiuspharma.com.
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 in a Phase 3 clinical trial.
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 trials for our product candidates, including our Phase III trial for Mino-Lok, including during the COVID-19 pandemic; the estimated markets for our product candidates, and the acceptance thereof by any market; our need for substantial additional funds; risks relating to the results of research and development activities; risks associated with developing our product candidates, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; 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 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.
Vice President, Corporate Development
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SOURCE Citius Pharmaceuticals, Inc.
Released December 15, 2020