Saturday, August 3, 2019

Citius Pharmaceuticals Presents Data on Mino-Lok® Showing 98% Clinical Efficacy

Source: Citius Pharmaceutical,  Inc. 8/30/2019

The Data Provides Proof of Salvaging Central Venous Catheters Colonized with Highly Virulent Pathogens in Patients with CLABSI/CRBSI


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. aureusor 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.

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