CRANFORD, N.J., May 26, 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 is providing free access to Mino-Lok® for healthcare
providers under an Expanded Access protocol to ease the burden
associated with the COVID-19 pandemic.
Through the Expanded Access protocol, an infected central venous
catheter can now be treated with Citius' Mino-Lok, potentially
avoiding the need for the removal and replacement procedure. Given
the challenges at today's hospitals, the patients, the hospital
staff, and the hospital system at large stand to benefit greatly
from free access to the Mino-Lok solution.
"Some of our investigators have told us that if Mino-Lok were
approved by the FDA, they would already be using it – particularly
in today's environment," commented Myron
Holubiak, Chief Executive Officer of Citius. "We clearly
must wait for the results of our clinical trial to fully market
Mino-Lok, but we do believe that it can benefit patients and help
ease the burden on the health care system. In these challenging
times, we welcome the opportunity to help in any way we can."
Mino-Lok is an antibiotic lock solution used to treat patients
with 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.
Mino-Lok is currently in a Phase 3 clinical trial for the treatment
of central line-associated bloodstream infections (CLABSIs). In
early February 2020, the Company
announced that the trial had reached the halfway point of
enrollment.
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). 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
providing Mino-Lok under the expanded use program prior to approval
for marketing by the FDA; 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
View original
content:http://www.prnewswire.com/news-releases/citius-announces-expanded-access-program-for-investigational-phase-3-mino-lok-301064966.html
SOURCE Citius Pharmaceuticals, Inc.