[Barrier Repair] [Ceragenins]

 

According to the FDA, the emergence of antibiotic resistant bacterial infections is one of the greatest threats to public health. A recent 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 antibiotics that is unlikely to generate resistant strains.

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  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), viruses (orthopox family) and certain cancers as all these cells share in common the presence of negatively-charged phospholipids on the cell membrane surfaces. The CSAs are electrostatically attracted to these membranes and induce apoptosis by rapid depolarization of the cell membranes. Unlike most antibiotics, which are bacteriastatic, the CSAs are bacteriacidal. Testing on the lead compound has been performed by the NIAID, NCI, National Jewish Hospital, Hershey Medical Center, BYU and other leading academic institutions.

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  A Cationic Steroid Antibiotic Active Against Vancomycin-Resistant Staphylococci and Enterococci.
   
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  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.

The CSAs 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. The CSAs are relatively easy to manufacture in quantity at low cost and have been made in multi-gram quantities at BYU.

Pharmaceutical Applications

• 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

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.

Medical Coatings

Every year millions of medical devices such as catheters, stints, shunts, and joint replacements are implanted in patients. These devices carry with them the risk of bacterial contamination, which can lead to serious and life threatening infections. There is a rapidly growing market for drug-coated medical devices. The current approach to antibiotic coated medical devices is based on coating the device with an antibiotic 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 anti-infective coatings designed to be attached to medical devices which promise to provide long duration broad spectrum anti-infective protection.

Status

Ceragenix plans to file PMA and 510k applications for selected anti-microbial coated medical devices during the next two years. The pharmaceutical use of Ceragenin™ conpounds for infectious diseases requires the filing of an IND prior to commencement of clinical trials. The Company plans to file its first IND in 2007 to evaluate the use of CSA-13 as a broad spectrum topical antibiotic (a replacement for mupirocin).