CRANFORD, N.J., Aug. 10,
2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc.
("Citius" or the "Company") (Nasdaq: CTXR), a late-stage
biopharmaceutical company dedicated to the development and
commercialization of first-in-class critical care products, today
announced that it has reached an important milestone in its
clinical trial for Mino-Lok®, an antibiotic lock
solution to salvage catheters in patients with catheter-related
bloodstream infections. Pending confirmation from an adjudication
committee of independent reviewers, the Company believes all 92
events required to complete the trial have been achieved. Several
patients remain in active treatment, which may result in additional
events.
"This is a significant milestone for Citius as we approach
completion of the Phase 3 Mino-Lok trial. As we complete therapy
for patients in active treatment, we will continue to enroll
patients in the pipeline and initiate shutdown activities," stated
Leonard Mazur, Chairman and Chief
Executive Officer of Citius.
Mino-Lok Phase 3 Trial Design
The Mino-Lok Phase 3 pivotal superiority trial (NCT02901717) is
a multi-center, randomized, open-label, blinded study to determine
the efficacy and safety of Mino-Lok (MLT), a novel antibiotic
lock therapy that combines minocycline with edetate disodium. The
trial is being conducted in the U.S. and India. The primary endpoint for this study is
the time (in days following randomization) to a catheter failure
event between randomization and TOC (Week 6) in the
Intent-to-Treat (ITT) Population. Additional secondary outcome
measures include overall success, microbiological eradication, and
clinical cure, among others.
Patients diagnosed with catheter related blood stream infections
(CRBSI/CLABSI) and who meet all necessary criteria for the study
are randomized in a 1:1 ratio to receive either Mino-Lok therapy or
standard of care antibiotic lock therapy.
Patients in the Mino-Lok arm receive one MLT dose daily with a
dwell time of two to four hours for a total of seven doses. For
subjects in the Control arm, the investigator determines the
antibiotic used in the lock, dose, dwell time, and number of days
of administration based on institutional standards or Infectious
Diseases Society of America (IDSA) guidelines.
About Mino-Lok
Mino-Lok is an antibiotic lock solution to treat patients with
catheter-related blood stream infections that Citius has licensed
from The University of Texas MD
Anderson Cancer Center. Citius believes Mino-Lok provides a
superior alternative to removing and replacing a central venous
catheter (CVC), leading to a reduction in serious adverse events
and cost savings to the healthcare system. If approved, Mino-Lok
would be the first and only FDA-approved treatment that salvages
central venous catheters that cause central line-related blood
stream infections.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to
the development and commercialization of first-in-class critical
care products, with a focus on oncology, anti-infectives in adjunct
cancer care, unique prescription products, and stem cell therapies.
The Company's diversified pipeline includes two late-stage product
candidates, Mino-Lok, an antibiotic lock solution for the treatment
of patients with catheter-related bloodstream infections, which is
currently enrolling patients in a Phase 3 Pivotal superiority
trial, and LYMPHIR™ (E7777), a novel IL-2R immunotherapy for an
initial indication in CTCL. Mino-Lok was granted Fast Track
designation by the FDA. LYMPHIR received orphan drug designation by
the FDA for the treatment of CTCL and PTCL. At the end of
March 2023, Citius completed
enrollment in its Phase 2b trial of
CITI-002, a topical formulation for the relief of hemorrhoids. For
more information, please visit www.citiuspharma.com.
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," "plan," "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, including those from existing
and new pipeline assets, including Mino-Lok; our need for
substantial additional funds; the estimated markets for our product
candidates and the acceptance thereof by any market; the ability of
our product candidates to impact the quality of life of our target
patient populations; our ability to commercialize our products if
approved by the FDA; our ability to obtain, perform under and
maintain financing and strategic agreements and relationships;
uncertainties relating to preclinical and clinical testing; the
early stage of products under development; our dependence on
third-party suppliers; our ability to procure cGMP commercial-scale
supply; market and other conditions; our ability to attract,
integrate, and retain key personnel; risks related to our growth
strategy; patent and intellectual property matters; 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. These risks have been and may be further impacted by
Covid-19 and could be impacted by any future public health risks.
Accordingly, these forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on these forward-looking statements. Risks
regarding our business are described in detail in our Securities
and Exchange Commission ("SEC") filings which are available on the
SEC's website at www.sec.gov, including in our Annual Report on
Form 10-K for the year ended September 30,
2022, filed with the SEC on December
22, 2022, and updated by our subsequent filings with the
Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof, and 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.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.