Epiceram

Treatment for Atopic Dermatitis

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

DENVER, September 26, 2005 - Ceragenix Pharmaceuticals, Inc. ("Ceragenix" or the "Company") (OTCBB: 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, 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 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 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."

Source: Ceragenix

Posted: September 2005

Epiceram FDA Approval History

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