CRANFORD, N.J., Sept. 4, 2019 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a
specialty pharmaceutical company focused on adjunctive cancer care
and critical care drug products, today reported that the FDA
responded to the Company's proposal to refine the endpoints in the
current Phase 3 pivotal trial for Mino-Lok.
The current Phase 3 trial being conducted compares Mino-Lok
therapy (MLT) to antibiotic lock therapy (ALT) to not only
disinfect colonized catheters causing bacteremias, but also to keep
the treated catheters functioning and infection free for 8 weeks
post therapy.
The new proposed primary endpoint is planned to demonstrate a
significant difference in the time to catheter failure when
comparing MLT to ALT. This is clinically important because
eliminating the source of infection enables antibiotic treatment of
the bacteremia to work more effectively and expeditiously.
Additionally, if a catheter can be maintained for the time that it
is needed, the patient does not need to be subjected to the
procedures for removing and replacing the catheter that are
associated with some serious adverse events.
The FDA noted that time to catheter failure is an acceptable
primary efficacy endpoint. They also instructed the Company to
identify and consider the various types of reasons for catheter
failure, and to show the clinical significance of this
endpoint.
"Citius is very pleased about the change in efficacy endpoints,"
said Mr. Myron Holubiak, President
and CEO of Citius Pharmaceuticals. "We believe this focus will
allow us to demonstrate the real benefit of Mino-Lok therapy (MLT)
which is that MLT works more efficiently and expeditiously to break
up biofilm and eliminate the bacteria causing the bacteremia than
current antibiotic lock therapies (ALTs). We now have a clearer way
forward to prove the superior efficacy of Mino-Lok to ALTs, and we
believe we can do this faster with fewer patients than originally
planned. At this time Citius believes that the change to the
primary endpoint will result in fewer than 150 total subjects in
Phase 3 trial. These changes would enable Citius to realize
clinical trial cost savings approaching $10
million."
The Company has recently submitted a response to the FDA with
the new sample size estimate which the agency is reviewing.
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 Mino-Lok®
Mino-Lok® is an antibiotic lock solution used to
treat patients with catheter-related blood stream infections
(CRBSIs). CRBSIs are very serious life-threatening infections,
especially in cancer patients receiving therapy through central
venous catheters (CVCs), and in hemodialysis patients where venous
access presents a challenge. The current Phase 3 trial is being
conducted in 36 sites. There are currently no approved therapies to
salvage infected central venous catheters (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 the
design of our ongoing Phase 3 trial for Mino-Lok, including the
change to the primary endpoint for that trial and our ability to
show clinical significance of that endpoint; risks associated with
conducting our Phase 3 trial for Mino-Lok, including completing
patient enrollment, patient retention and the reasons for catheter
failure in the trial; risks associated with sourcing components of
our product candidates; our dependence on third-party suppliers;
our ability to obtain, perform under and maintain financing and
strategic agreements and relationships; 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
identify, acquire, close and integrate product candidates and
companies successfully and on a timely basis; our ability to
attract, integrate, and retain key personnel; our need for
substantial additional funds; 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
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.