CRANFORD, N.J., Dec. 19, 2019 /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 a positive outcome
of the pre-specified interim futility analysis for the Phase 3
clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks.
The analysis was conducted by the Mino-Lok trial Data Monitoring
Committee ("DMC"), an independent panel of experts charged with
periodically monitoring the safety and efficacy of the progress of
the pivotal trial. The Company reached and completed the
prespecified 40% enrollment required for the interim futility
analysis in late September and, based on the analysis of the data
and recommendations of the DMC, will proceed with the current trial
as planned. Topline data from the superior efficacy interim
analysis, the next major milestone in the Mino-Lok trial, is
expected in the first half of 2020. The market potential for
an effective antibiotic lock therapy is estimated at $750 million per year in the U.S. and
approximately $1.5 billion per year
worldwide.
"We are extremely happy and proud that the first independent
expert review of the patient data in our Mino-Lok trial concludes
that our study is on track. Enrollment has continued since
finalizing the 40% level futility report, and we have now reached
the midpoint of our study. The DMC will evaluate clinical data at
the 75% level of enrollment to see if Mino-Lok demonstrates
superior efficacy versus standard-of-care antibiotic locks," said
Myron Holubiak, the Chief Executive
Officer of Citius. "We would also like to thank all of the
patients, study investigators, and support personnel at the 32
clinical sites that are participating in our trial. Lastly, we also
want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer
Center in advancing this novel therapy."
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 to
existing therapeutic approaches. For more information, please visit
www.citiuspharma.com.
About MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center in
Houston ranks as one of the
world's most respected facilities for cancer patient care,
research, education and prevention. The institution's sole mission
is to end cancer for patients and their families around the world.
MD Anderson is one of only 45 comprehensive cancer centers
designated by the National Cancer Institute (NCI) and is ranked
No.1 for cancer care in U.S. News & World Report's most recent
"Best Hospital's" survey. The center has ranked as one of the
nation's top two hospitals since the survey began in 1990, and has
ranked first for 11 of the past 14 years. MD Anderson receives a
cancer center support grant from the NCI of the National Institutes
of Health (P30 CA016672).
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 where venous access presents a
challenge. There are currently no approved therapies to salvage
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 associated with conducting
our Phase 3 trial for Mino-Lok, including completing patient
enrollment; our need for substantial additional funds; 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 that preclinical results may not be predictive
of clinical results and our ability to file an IND; 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
(D) 908-956-7674
(C) 646-522-8410
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.