Ceragenix Signs Letter of Intent with the Centers for Disease Control and Prevention (CDC) to Enter into a Cooperative Research and Development Agreement (CRADA)

The CRADA Will Evaluate the Efficacy of Ceragenix's Cationic Steroid Antibiotic ("CSA") Antimicrobial Coating in the Prevention of Bacterial Biofilm Growth on Medical Devices

DENVER, Oct 25, 2005 -- Ceragenix Pharmaceuticals, Inc. ("Ceragenix"), a development stage biopharmaceutical company, (CGXP) today announced that it has signed a Letter of Intent to enter into a Cooperative Research and Development Agreement ("CRADA") with the Centers for Disease Control and Prevention ("CDC") to evaluate the efficacy of Ceragenix's cationic steroid ("CSA") antimicrobial coating in the prevention of bacterial biofilm growth on medical devices. A biofilm is a slime-like mulitcellular bacterial colony that is typically highly resistant to conventional antibiotics. Biofilm infections are of significant medical concern as they commonly are associated with in-dwelling medical devices such as catheters and vascular grafts and have the potential to cause blood-stream infections. According to the CDC, infections associated with central venous catheters account for 250,000 cases of blood stream infections annually. The attributable mortality for such infections is estimated to range between 12% to 25% and the annual costs of caring for patients with central venous catheter infections may be as high as $2.3 billion.

The CRADA's research plan will evaluate Ceragenix's CSA antimicrobial coating using the CDC's Biofilm Reactor, a specially designed device that is able to reproducibly grow biofilms in a high shear environment. Dr. Rodney Donlan, team leader of the CDC's Biofilm Research Laboratory, devised the protocol for testing and will assist in the evaluation of the results. The testing will be conducted by Dr. Paul B. Savage's laboratory at Brigham Young University (Provo, UT). Dr. Savage is a Professor of Chemistry and Biochemistry at BYU and the inventor of the CSA technology that BYU has exclusively licensed to Ceragenix. BYU is also a party to the CRADA.

"This collaboration with the CDC illustrates the progress we continue to make with our infectious disease program," said Steven Porter, Chairman & CEO of Ceragenix. "Working with the CDC will strengthen our pursuit of an effective long-lasting antimicrobial coating for medical devices."

About the CSA technology

CSAs represent a new class of antibiotics that in preclinical testing have shown efficacy against gram-negative, gram-positive and multidrug resistant bacteria such as VRSA, VRE, MRSA, Pseudomonas, E. Coli and others. The CSAs are synthesized aminosterols that mimic (or exceed) the antimicrobial activity of the naturally occurring antimicrobial peptides (such as cathelicidin) that form part of the human body's innate immune system. These are positively charged compounds that are electrostatically attracted to the negatively charged phospholipids found on the cell membranes of bacteria. The CSAs are bacteriacidal and work by rapidly depolarizing the cell membranes of bacteria. The CSA antimicrobial coating is based on a commercially available coating for catheters that has been chemically modified to include a CSA. Unlike other conventional approaches to antimicrobial coatings for medical devices which require the antimicrobial active to elute from the surface of the device, the CSA coating remains covalently attached to the device and offers the potential for long-lasting antimicrobial efficacy with no systemic exposure. Preliminary testing has shown that the CSAs are highly active against a broad range of biofilms at concentrations less than 15 micrograms/ml.

About Ceragenix

Ceragenix is a development stage biopharmaceutical company focused on dermatology and infectious disease. 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) that form human-identical skin barriers. Defects in the skin's barrier function play critical roles in the pathogenesis of skin diseases such as eczema, irritant contact dermatitis and other common skin disorders. The Company's patented Cationic Steroid Antibiotic (CSA) technology provides the basis for its novel antimicrobial medical device coating that may be attached to various medical devices to provide potentially long duration antimicrobial activity. Ceragenix also plans to develop CSAs for use as topical and systemic antibiotic therapies in the treatment of skin infections (MRSA), burn wound infections, eye infections and other indications.

Contacts:
Ceragenix
Steven S. Porter, 720-946-6440
or
CEOcast, Inc. for Ceragenix
Ed Lewis, 212-732-4300