CRANFORD, N.J., April 30, 2019 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius") (Nasdaq: CTXR), a specialty
pharmaceutical company focused on adjunctive cancer care and
critical care drug products, provided a report today on the
clinical efficacy of Mino-Lok against various pathogens that are
encountered in colonized catheters that cause bacteremia, either
central line associated bloodstream infection ("CLABSI") or
catheter related bloodstream infection ("CRBSI"). In a
meta-analysis of two separate studies conducted in four
institutions in four different countries (see table), it was shown
that Mino-Lok was 98% effective (49/50) in salvaging catheters that
caused bacteremia. These data included Staph. aureus, and a
number of gram negative, highly virulent pathogens.
Mino-Lok Therapy
(MLT): Analysis of CVC Salvage by Pathogen
(meta-analysis of
four centers*)
|
Bacteria causing
bacteremia
|
MDA MLT
Treated1
(n)
|
Ex-U.S. MLT
Treated2
(n)
|
All MLT
Treated
(n)
|
Catheters
Salvaged
(n/N) (%)
|
Gram
+
|
16
|
10
|
26
|
26/26
(100%)
|
Coagulase negative
staphylococci (CNS)
|
5
|
7
|
12
|
12
|
Streptococcus
|
5
|
1
|
6
|
6
|
Staphylococcus
aureus3
|
4
|
1
|
5
|
5
|
Enterococcus4
|
2
|
1
|
3
|
3
|
|
|
|
|
|
Gram
-
|
14
|
10
|
24
|
23/24
(96%)
|
E.
coli5
|
7
|
2
|
9
|
9
|
Pseudomonas
|
3
|
1
|
4
|
4
|
Klebsiella
|
1
|
4
|
5
|
5
|
Enterobacter
|
3
|
1
|
4
|
4
|
Burkholderia
cepacia
|
0
|
1
|
1
|
0
|
Rhizobium
radiobacter
|
0
|
1
|
1
|
1
|
|
|
|
|
|
Total subjects
treated
|
30
|
20
|
50
|
49/50
(98%)
|
*30 patients treated
at MD Anderson Cancer Center in U.S.; nine patients treated at
American University of Beirut Medical Center in Beirut, Lebanon;
nine patients treated at Hospital Israelita Albert Einstein in Sao
Paulo, Brazil; and two patients treated at St. Luke's International
Hospital in Tokyo, Japan.
|
|
1. Raad I, et
al. Antimicrob Agents Chemother. 2016; 60(6): 3426-3432.
|
2. Hachem R, et
al. Expert Rev Med Devices. 2018; 15(6):461-466.
|
3. One subject
in the MDA study was also positive for Corynebacterium.
|
4. One subject
in the MDA study was also positive for Corynebacterium.
|
5. One subject
in the Ex-US study was also positive for Streptococcus.
|
Mr. Myron Holubiak, CEO of
Citius, said, "The changing microbiology of catheter associated
bacteremia in cancer patients is a very important development. Gram
negative organisms and fungi such as Candida have increased
substantially since the 1990s and present difficult treatment
challenges. Furthermore, the low salvage rates with antibiotic
locks for CLABSI/CRBSI caused by S. aureus are also a
significant concern. The current evidence for antibiotic locks is
mainly based on treatment for coagulase-negative staphylococci.
IDSA guidelines do not support antibiotic locks for CLABSI/CRBSI
with S. aureus or yeast, or resistant gram-negative
pathogens. We have now demonstrated that Mino-Lok may be very
effective clinically in salvaging catheters that have been
colonized with a wide range of pathogens including the most
virulent. While the clinical data for Mino-Lok are highly
encouraging as they relate to these highly virulent pathogens, we
recognize more work needs to be done. The company is currently
studying Mino-Lok in a phase 3 trial in participating institutions,
all located in the U.S."
Mino-Lok®
Mino-Lok is an antibiotic lock solution used to treat patients
with CLABSIs/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 to salvage infected central venous catheters
(CVCs).
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.
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 relating to the results
of research and development activities, including that preclinical
results may not be replicated in clinical trials; uncertainties
relating to preclinical and clinical testing; patent and
intellectual property matters; risks associated with conducting our
phase 3 trial for Mino-Lok, including completing patient enrollment
and opening study sites; the estimated markets for our product
candidates and the acceptance thereof by any market; risks related
to our growth strategy; 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; our ability to attract, integrate and retain
key personnel; our need for substantial additional funds;
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
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.