CRANFORD, N.J., Nov. 30, 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 the
completion of a Boston Analytical study "Silicone Disk Method for
In Vitro Assessment of Antimicrobial Activity Against
Resistant Staphylococcal Biofilms by Minocycline-EDTA-Ethanol and
EDTA-Ethanol Lock Solutions." This study demonstrated that all
three components of Mino-Lok (30 mg/mL EDTA, 19.5% ethanol and 1
mg/mL minocycline) were superior to EDTA/ethanol (30 mg/mL EDTA and
19.5% ethanol). There were two strains of Staphylococcus
aureus used for the inocula and two samples of each strain were
tested as four reference groups. The test solutions were examined
following incubation for the following three time points: 60
minutes; 90 minutes; and 120 minutes. The Colony Forming Units
(CFU)/Disk value was assessed from 10 disks at each time-point for
each group. The results indicate that when the exposure time is 60
minutes, the number of CFU/Disk under the MLT group is
significantly smaller than the number of CFU/Disk under the
EDTA/ethanol group in one strain and very close to significance
(p-value = 0.0598) in the second strain. For all exposure times,
the number of CFU/Disk was always lower in the MLT treated disks
compared to the EDTA/ethanol treated disks.
The researchers concluded that "… taken together, the results
suggest that MLT can eradicate the biofilm quicker than
EDTA/ethanol."
"Staph aureus is one of the most worrisome pathogens in
catheter related bloodstream infections (CRBSI). This pathogen
receives special consideration even in the IDSA guidelines for
treating CRBSI. We are very pleased to show that Mino-Lok appears
to be more effective, and work more expeditiously, than even
ethanol," commented Myron Holubiak,
Chief Executive Officer of Citius. "It has been demonstrated in
earlier studies and reports that all three components of Mino-Lok
are necessary to eradicate MRSA and Candida parapsilosis.
More recently we showed that MLT was effective in vitro
against 10 strains of Candida
Auris. All of these pathogens are of great concern in
cancer patients with central lines. As we approach the final stages
of our pivotal trial, we are very excited to be able to report new
findings about Mino-Lok. Our pivotal trial is designed to show the
superiority of Mino-Lok to standard antibiotic locks in
time-to-catheter-failure. If all these studies prove to be
successful, we believe ready to use Mino-Lok will be superior to
local pharmacy mixed antibiotic locks in both efficacy and dosing
schedules."
Mino-Lok has the potential to change the standard of care, which
currently calls for a procedure to remove and replace the infected
catheter. Each year, up to 500,000 CVCs of the 7 million used
become infected and lead to CLABSIs, 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. According to
DelveInsight, the market size of CLABSIs and closely associated
catheter-related bloodstream infections (CRBSIs) in the global
market is expected to reach $1.84
billion in 2028, up from $1.24
billion in 2017.
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 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; risks
associated with conducting trials for our product candidates,
including our Phase III trial for Mino-Lok; risks relating to
the results of research and development activities; our need for
substantial additional funds; the estimated markets for our product
candidates, and the acceptance thereof by any market; 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
(M) 646-522-8410
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.