CRANFORD, N.J., Feb. 4, 2020 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a
specialty pharmaceutical company focused on adjunctive cancer care
and critical-care drug products, today announced that the Company's
lead program, Mino-Lok vs. standard-of-care ("SOC") antibiotic
locks, has randomized its 72nd patient, thereby passing the halfway
point for enrollment in this Phase 3 trial. The Company previously
announced the results of a futility analysis when it passed the
threshold of 40% of patients completing end of therapy. That
analysis showed a positive outcome, as it met the prespecified
interim futility analysis criteria. The next major milestone in the
Mino-Lok trial, expected to be achieved in the first half of 2020,
will be the 75% interim analysis for superior efficacy. The
endpoints for this analysis require that the time to catheter
failure be at least 38 days for Mino-Lok vs. 21 days for SOC
antibiotic locks.
"We are extremely happy that our trial is proceeding according
to plan. The independent drug monitoring committee ("DMC") will
next evaluate the clinical data at the 75% level of enrollment to
see if Mino-Lok demonstrates superior efficacy versus SOC
antibiotic locks," said Myron
Holubiak, Chief Executive Officer of Citius. "We believe
that the Mino-Lok clinical trial will be a major contribution to
the study of catheter-related bloodstream infections (CRBSI) and
the utility of antibiotic locks. Effective alternatives are needed
to the practice of removing and replacing infected central venous
lines."
About Mino-Lok®
Each year, up to approximately
500,000 central venous catheters of the 7 million used in the U.S.
become infected and lead to CRBSIs, 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. Mino-Lok is an
antibiotic lock solution that is being developed to treat patients
with 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 penetrates biofilm, eradicates bacteria and
salvages infected, indwelling vascular catheters while providing
anticlotting properties. Mino-Lok has the potential to change the
standard of care for the management of these serious infections.
The market potential for an effective antibiotic lock therapy is
estimated to be $750+ million per year in the U.S. and
approximately $1.5 billion
worldwide.
About Citius Pharmaceuticals, Inc.
Citius is a
specialty pharmaceutical company dedicated to the development and
commercialization of critical-care products, with a focus on
anti-infectives, cancer care and unique prescription products that
use innovative, patented or proprietary formulations of previously
approved active pharmaceutical ingredients. We seek to achieve
leading market positions by providing therapeutic products that
address unmet medical needs. By using previously approved drugs
with substantial safety and efficacy data, we seek to reduce the
risks associated with pharmaceutical product development and
regulatory requirements. Citius develops products that have
intellectual property protection and competitive advantages over
existing therapeutic approaches. For more information, please visit
www.citiuspharma.com.
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," along with 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 our Phase III trial for Mino-Lok, including our ability
to complete patient enrollment; risks relating to our need for
substantial additional funds; possible changes in the estimated
markets for our product candidates and the acceptance thereof by
any market; risks relating to the results of research and
development activities; risks associated with developing Mino-Wrap,
including the risk that preclinical results may not be predictive
of clinical results or of our ability to file an IND; uncertainties
relating to preclinical and clinical testing; uncertainties
associated with the early stage of products under development;
risks related to our growth strategy; risks related to our ability
to obtain, perform under, and maintain financing and strategic
agreements and relationships; uncertainties relating to our ability
to identify, acquire, close and integrate product candidates and
companies successfully and on a timely basis; uncertainties
relating to our ability to attract, integrate and retain key
personnel; possible changes in government regulation; risks
associated with patent and intellectual property matters; and risks
relating to 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 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.