Ceragenix Submits 510(k) Application to FDA for Epiceram(TM), a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders

DENVER, Sep 26, 2005 -- Ceragenix Pharmaceuticals, Inc. ("Ceragenix" or the "Company") (CGXP), a development stage biopharmaceutical company, today announced that Ceragenix Corporation, its wholly owned subsidiary, has submitted a 510(k) application to the United States Food and Drug Administration ("FDA"). The application seeks marketing clearance for Epiceram(TM), a topical cream intended for use in alleviating the pain, itching and burning of atopic dermatitis (eczema), irritant contact dermatitis, radiation dermatitis and xerotic skin conditions. If cleared by the FDA, Epiceram(TM) will be the Company's first commercial product.

Atopic dermatitis, also known as eczema, is a common skin disorder that afflicts over 15 million Americans and is typified by red, scaly, itchy skin. For many years the therapeutic options were limited to use of varying strengths of topical corticosteroids and use of moisturizers. While topical corticosteroids are helpful in reducing skin inflammation, recent research reported at the International Symposium on Atopic Dermatitis (ISAD) has shown that use of potent topical corticosteroids can lead to a disruption in the skin's barrier leading to increased risk of further flares. Research by Dr. M.J. Cork (University of Sheffield, UK) and others have shown that a substantial portion of persons who suffer from eczema have a defect in their skin's barrier function. This porous skin barrier allows external triggers such as allergens and pollutants to pass through the skin's surface and induce an inflammatory response.

Dr. Peter M. Elias, Professor of Dermatology at UCSF and Ceragenix's Chief Scientific Officer, commented that "fortifying the skin's barrier to block such external triggers from passing through the surface of the skin and inducing inflammation is an important alternative approach in alleviating the symptoms of atopic dermatitis and other skin disorders."

The National Institute of Health has recently awarded Dr. Elias a $1.2 million research grant to study the role of the skin's barrier function in maintaining health. According to Steven Porter, Ceragenix's Chairman and CEO "The submission of our 510(k) application for Epiceram(TM) marks an important milestone in our company's history and we look forward to reporting our progress on this and on other fronts during the months ahead."

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.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, the following: the ability of the Company to raise capital in a timely manner, the ability of the Company to raise sufficient capital to finance its planned pharmaceutical activities, the FDA concurring with the Company that the 510(k) application is the appropriate approval process for Epiceram(TM), receiving the necessary marketing clearance approvals from the FDA, successful clinical trials of the Company's planned products, the ability of the Company to commercialize its planned products, market acceptance of the Company's planned products, and the Company's ability to successfully compete in the marketplace. Although management believes that the assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance that the forward-looking statements will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved. For further information, please see the company's filings with the SEC, including its Forms SB-2, 10-KSB, 10-QSB and 8-K. The Company assumes no obligation to update its forward-looking statements to reflect actual results or changes in factors affecting such forward-looking statements.

Contacts:

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