CRANFORD, N.J., June 2, 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 received positive feedback from the Food and Drug
Administration (FDA) on its proposed catheter compatibility studies
for the Company's Mino-Lok® therapy. The studies, if and when
successfully completed, should allow Mino-Lok to be labeled for use
with all commercially available central venous catheters (CVCs) and
peripherally inserted central catheters (PICCs) on the U.S. market.
It is further assumed that these studies will meet European and
world standards.
The ability to be labeled without restrictions with respect to
catheter type would allow Mino-Lok unrestricted access to the full
U.S. and world markets for an effective antibiotic lock therapy for
central line-associated bloodstream infections (CLABSIs), which are
estimated to be over $1.5 billion per
year worldwide. The catheter compatibility studies will be
conducted in parallel with the completion of the ongoing Phase 3
clinical study. The Company announced in early February 2020 that this pivotal trial had reached
the halfway point for enrollment. The next milestone in the trial
is the result of an interim efficacy analysis, which is expected to
occur in the second half of 2020.
"We believe we continue to check all the boxes required for an
NDA submission," commented Myron
Holubiak, Chief Executive Officer of Citius. "According to
our planned dosing recommendations, the Mino-Lok solution dwells in
the catheter for two hours per day for 5 to 7 days. This would be
between 10 to 14 hours of aggregate, but intermittent, exposure
time of the catheter to Mino-Lok. We believe that this exposure is
far lower than what is recommended for home-brewed antibiotic lock
solutions, which should lead to less intrusive therapy and fewer
days on therapy for patients."
"The shorter dwell time for Mino-Lok also means that the
catheter is available for its intended purpose, allowing treatment
for the underlying disease to continue. Additionally, and more
importantly, 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
home-brewed antibiotic locks in both efficacy and dosing
schedules," Mr. Holubiak concluded.
Mino-Lok is an antibiotic lock solution used to treat patients
with CLABSIs and catheter-related bloodstream infections (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
procedures. It 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
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). CLABSIs/CRBSIs are very serious, especially in
cancer patients receiving therapy through central venous catheters
(CVCs) and in hemodialysis patients, for whom venous access
presents a challenge. There are currently no approved therapies for
salvaging infected CVCs.
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 of
FDA acceptance of our compatibility studies and, if so, the
successful completion of and results from the studies; our need for
substantial additional funds; the estimated markets for our product
candidates, and the acceptance thereof by any market; 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; 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
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.