Full Press Release Details
Positive Outcome of Interim Futility Analysis for its Phase 3 Mino-Lok Pivotal Trial
CRANFORD, N.J. - December 19,
2019 -- 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).
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.
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
Vice President, Corporate Development