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Ceragenix Contact Lens Disinfectant Solution Demonstrates Potent Activity Against Bacteria and Fungi
Business Wire, March 5, 2007
New In Vitro Data Presented at International Ophthalmic Conference
DENVER -- Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP), a biopharmaceutical company focused on infectious disease and dermatology, today announced that Dr. Paul B. Savage, a Reed M. Izatt Professor of Chemistry and Biochemistry at Brigham Young University (BYU), presented data on the use of Ceragenins[TM] for ophthalmic applications at the 1st Asia-ARVO meeting organized by the Singapore Eye Research Institute on March 2, 2007 in Singapore.
The in vitro data presented at the conference demonstrated that:
1) A developmental Ceragenin-based contact lens disinfectant
solution was able to virtually eradicate within 1.5 hours,
all five strains of bacteria and fungi, according to the
test specified under the FDA's guidance document for
approval of contact lens disinfectant solutions - also
known as the "stand-alone" test.
2) When the Ceragenin-based contact lens disinfectant solution
was compared to the two leading brands on the market in its
ability to kill a strain of the fungal pathogen fusarium
solani, the Ceragenin solution showed a 4.19 log reduction
(the limit of detection) at 1.5 hours of soaking versus
0.48 and 0.26 log reductions for the two leading brands.
At six hours, the two comparators achieved log reductions
of 3.07 and 0.83 log reductions, while the Ceragenin
solution had completely killed the fungus by 1.5 hours.
A 1.0 log reduction is equal to a 90% kill, leaving 10% of
the fungi still viable. A 4.0 log reduction is equal to a
99.99% kill (the limit of detection in this test was 4.19
log which the Ceragenin solution achieved). The fungal
pathogen fusarium solani was the organism responsible for
last year's worldwide outbreak of eye infections that
resulted in a voluntary recall of a leading brand of
contact lens disinfectant solution.
3) When tested against a strain of fungal biofilm (candida),
the Ceragenin solution was able to virtually eradicate the
biofilm within six hours (a 6.0 log reduction), while two
of the three leading commercial brands tested in the same
test achieved log reductions of under 1.0 log and the third
achieved a log reduction of under 2.0 logs. Biofilms are
slime like aggregations of bacteria or fungi and are known
to be far more difficult to eradicate than free living
bacteria or fungi.
In his presentation, Dr. Savage identified three areas of potential use of Ceragenins in ophthalmology:
1) use in contact lens disinfectant solution to provide
optimal protection against bacterial and fungal pathogens;
2) use to treat contact lens storage cases to help prevent the
growth of biofilms on storage containers (as a potential
reservoir for infection); and
3) use to treat disposable contact lenses and intraocular
lenses to provide an anti-infective surface on the lens
material to help reduce the risk of infection.
Steven S. Porter, CEO of Ceragenix, stated, "We are encouraged by the results of the recent testing carried out by independent laboratories which have shown this excellent activity against ocular pathogens. The worldwide market for contact lens disinfectant solutions is in excess of $1 billion annually and if further studies show similar effectiveness, we believe a Ceragenin-based contact lens disinfectant solution may help reduce the risk of infection among contact lens wearers. Encouraged by these results, we plan to seek a partner to assist in further testing and commercialize this opportunity in ophthalmology."
Any ophthalmolic application of Ceragenin-based solution or products will require approval from the United States Food and Drug Administration (FDA). Ceragenix has not yet filed an application with the FDA seeking clearance to market any ophthalmolic products.
About Ceragenix
Ceragenix Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops and commercializes novel anti-infective drugs based on its proprietary class of compounds, Ceragenins (or CSAs). Active against a broad range of gram positive and negative bacteria, these agents are being developed as anti-infective medical device coatings and as therapeutics for antibiotic-resistant organisms. Ceragenix also owns exclusive rights to Barrier Repair Technology for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. Ceragenix's patented Barrier Repair Technology, invented by Dr. Peter Elias and licensed from the University of California, is the platform for the development of two prescription topical creams--EpiCeram[TM] and NeoCeram[TM]. For additional information on Ceragenix, please visit www.ceragenix.com.
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