[Barrier Repair] [Ceragenins™]

 

Ceragenins are synthetic non-peptide mimics of a key component of the human innate immune system.

Key Antimicrobial Attributes: highly effective at low concentrations, broad spectrum of activity, long duration of activity, limited chance of resistance, prevents and eradicates biofilms.

Ceragenin™ CSA-13 may be incorporated directly into medical devices, coated as CeraShield™ onto medical devices, or used in solution.

General Physical Characteristics of Ceragenins™:

• White, lyophilizable powder
• Relatively simple to prepare and purify
• Readily soluble in water (up to 5 percent)
• Heat stable (autoclavable)
• Can be stored for long periods without degradation
• Simplicity of structure allows Ceragenins™ to attach to polymers and surfaces

According to the FDA, the emergence of antibiotic resistant bacterial infections is one of the greatest threats to public health. An editorial in the New England Journal of Medicine described the prevalence of methicillin-resistant staph aureus (MRSA) in hospitals as now reaching epidemic proportions. Clearly, there is an urgent need for a new class of antimicrobial that is unlikely to generate resistant strains.

• Click Here to Download and View the Poster Exhibit
  Activity of a Novel Cationic Steroid Antimicrobial (CSA-13) Against Staphylococcus Aureus and Bacterial Species Associated with Infections in Cystic Fibrosis Patients.
   
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  Activity of a Novel Cationic Steroid Antimicrobial (CSA-13) Targeting Aerobic and Facultative Gram-Negative Bacilli, Gram-Positive Anaerobes, and Select Agent Surrogate Strains.
   
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  Thin Film Containing a Cationic Steroid Antibiotic Displays Bactericidal Activity.

Ceragenix has licensed the exclusive worldwide rights to a patented new class of small molecule compounds from Brigham Young University. These compounds are aminosterols that bear a positive charge and are termed "Cationic Steroid Antibiotics" or CSAs or Ceragenins™. Extensive preclinical testing has shown that the lead compound — CSA-13 — is highly effective at clinically relevant concentrations against a broad spectrum of bacterial infections, including multi-drug resistant organisms such as Pseudomonas, MRSA and VRSA. The compounds are polyfunctional and have activity not just against bacteria, but are also active against certain fungi (Candida) and viruses (orthopox family). All these cells share in common the presence of negatively-charged phospholipids on the cell membrane surfaces. CSAs are electrostatically attracted to these membranes and induce apoptosis by rapid depolarization of the cell membranes. Unlike most antibiotics, which are bacteriostatic, CSAs are bactericidal. Testing on the lead compound has been performed by the NIAID, NCI, National Jewish Hospital, Hershey Medical Center, BYU and other leading academic institutions.

• Click Here to Download and View the Poster Exhibit
  A Cationic Steroid Antibiotic Active Against Vancomycin-Resistant Staphylococci and Enterococci.
   
• Click Here to Download and View the Poster Exhibit
  Kill Kinetics of CSA-13 and Comparators Against Staphylococci with Raised Glycopeptide MICs.
   
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  A Cationic Steroid Antibiotic Active against Highly Tobramycin-Resistant Pseudomonas aeruginosa.

Ceragenins™ share structural features in common with the antimicrobial peptides that form part of our body's innate immune system, and as such are unlikely to generate resistant strains. Ceragenins™ are relatively easy to manufacture in quantity at low cost and are currently made at Brigham Young University.

Medical Device Applications

Every year millions of medical devices such as catheters, stents, and joint replacements are implanted in patients. These devices carry the risk of bacterial contamination, which can lead to serious and life threatening infections. There is a rapidly growing market for drug-eluding medical devices. The current approach to antibiotic coated medical devices is based on coating the device with an antimicrobial that releases into the body over time. These coatings may dissipate in just a matter of days and become ineffective in preventing infections in long duration devices. Ceragenix is developing a new class of antimicrobials which may be incorporated directly into medical devices, coated as CeraShield™ onto medical devices, or used in solution.

According to the Centers for Disease Control and Prevention (CDC)

• Hospital-acquired infections currently kill as many as 90,000 people annually in the United States, up from 13,000 in 1992.
   
• Another 1.9 million people nationwide who acquire nosocomial infections endure longer hospital stays for additional treatment and recovery.
   
• While bacterial infections were once lethal only to seriously ill hospital patients, new community-associated strains of MRSA now pose a serious health threat to otherwise healthy persons.

Pharmaceutical Applications

• Potential treatment for C. difficile in the gastrointestinal tract.
  
  
• CSA-54 may inhibit HIV infections.
  
  
• Bacterial infections in burn clinics (60% of the deaths in burn victims are attributed to uncontrolled bacterial infections).
   
• Replacement for mupirocin (a topical antibiotic with over $150 M in annual sales).
   
• Broad spectrum antibacterial and antiviral agent for treatment of bacterial and viral infections that afflict children with atopic dermatitis.
   
• Potential for use against serious multi-drug resistant bacterial infections.