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.
About Mino-Lok®
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.
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 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.
Contact:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(C) 646-522-8410
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.