Full Press Release Details
Pharmaceuticals Reports Positive Results from Recent Data Monitoring Committee Meeting for Mino-Lok Phase 3 Trial
makes recommendation to continue trial with no modifications and requests an ad hoc meeting in near future
N.J., Sept. 29, 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 a Data Monitoring Committee (DMC) meeting was held to review the data being generated and analyzed in the Mino-Lok
phase 3 trial, and to make recommendations to Citius as to any action that may be necessary regarding the study.
reviewing these data, the DMC members stated that they did not find any safety signals; and they also recommended continuing the
trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future.
Data Monitoring committee is an independent panel of experts that review progress regarding the safety and efficacy of drugs in
clinical trials, and to determine if the trial may be futile in achieving its endpoints or if the trial should be modified in any
"We are very pleased
with the outcome of the DMC's independent review of the Mino-Lok data. This information is very encouraging and supports
the confidence that we have long held in the safety and efficacy of Mino-Lok," said Myron Holubiak, Chief Executive Officer
of Citius. "Despite challenges in recruiting patients recently due to the COVID-19 pandemic, we have continued to recruit
patients and are now approaching the late stage of our pivotal study." Holubiak continued, "I want to thank the DMC
committee members for their thoughtful review, and also all of the study investigators and their staff that continue to support
our trial in these challenging times."
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.
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.
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 relating
to the results of research and development activities; risks associated with conducting clinical trials and drug development; our
need for substantial additional funds; our dependence on third-party suppliers; patent and intellectual property matters; market
and other conditions; our ability to attract, integrate, and retain key personnel; the risk of successfully negotiating within
the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; the estimated markets for
our product candidates and the acceptance thereof by any market; risks related to our growth strategy; uncertainties relating to
preclinical and clinical testing; the early stage of products under development; 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; government regulation; 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.
Vice President, Corporate Development
(O) 908-967-6677 x105