CRANFORD, N.J., Sept. 15, 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 has filed an amendment to its Mino-Lok phase 3 protocol. This
amendment was designed to allow for more efficient follow-up and
record-keeping of required clinical trial documentation given
COVID-19 restrictions. With personal visits having been severely
restricted, Citius issued instructions in the form of file notes to
sites in April and has now formalized these instructions. The FDA
released guidance on conduct of clinical trials of medical products
during COVID-19 in March 2020,
updated in July 2020.
"In these challenging times we are working closely with our
Principle Investigators (PIs) and their staff to keep the enormous
amount of record-keeping associated with any clinical trial as
simple and accurate as possible," said Myron Holubiak, Chief Executive Officer of
Citius. Holubiak continues, "We have been pleased with the
responsiveness of our partners and internal team to today's
ever-changing situation. Like all other companies, Citius is facing
significant challenges in maintaining progress in its clinical
trials. We are especially affected since our site-of-care is
frequently the ICU, which is the most resource-stressed site in the
hospital because of COVID-19. We expect to be able to conduct our
Drug Monitoring Committee meeting as planned at the end of the
month, and we look forward to our discussions with these
independent experts."
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-LokĀ®
Mino-LokĀ® 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
associated with conducting clinical trials and drug development;
patent and intellectual property matters; market and other
conditions; our ability to attract, integrate, and retain key
personnel; our need for substantial additional funds; the risk of
successfully negotiating within the option period a license
agreement with Novellus, Inc. for our planned NoveCite therapy for
ARDS; risks associated with conducting clinical trials and drug
development; the estimated markets for our product candidates and
the acceptance thereof by any market; risks related to our growth
strategy; risks relating to the results of research and development
activities; 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; our dependence on third-party suppliers;
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.
Contact:
Andrew
Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(M) 646-522-8410
ascott@citiuspharma.com
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content:http://www.prnewswire.com/news-releases/citius-files-addendum-to-mino-lok-phase-3-trial-record-keeping-protocol-to-advance-trials-with-covid-19-compliance-301131345.html
SOURCE Citius Pharmaceuticals, Inc.