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Ceragenix Reports Results of Study of Its Epiceram (TM) Barrier Repair Cream; Study Demonstrates That Epiceram(TM) Accelerated Skin Barrier Recovery in Treated vs. Untreated Eczema Sites.

DENVER -- Ceragenix Pharmaceuticals, Inc. ("Ceragenix" or the "Company) (OTCBB: CGXP), a development-stage biopharmaceutical company, today announced that the results of a clinical study showed that application of Epiceram(TM) was able to improve the symptoms afflicting persons with moderate-to-severe eczema. The study showed that Epiceram(TM) accelerated skin barrier recovery in treated vs. untreated eczema sites. This objective measurement in the improvement of skin barrier function correlated to a 100% reduction in reported symptoms of itch at 3 and 6 hours; an over 50% reduction in dry skin; over 45% reduction in scaliness and an over 37% reduction in irritation/inflammation (all at 3 and 6 hours). Epiceram(TM) is an investigational topical barrier repair cream based on the discovery of Dr. Peter Elias and exclusively licensed by Ceragenix from The Regents of the University of California. In this small but statistically significant study conducted by AMA Laboratories, Inc., an independent testing laboratory, five persons with moderate-to-severe eczema applied a single application of Epiceram(TM), and objective measures of trans-epidermal water loss (TEWL) and subjective readings of itch, dry skin, scaliness and irritation/inflammation were obtained at baseline and again at 3 and 6 hours. TEWL measurements were obtained from untreated skin sites as well as tape-stripped sites and sites of active eczema

The skin's barrier is composed of a thin sheet of epidermal lipids about half the thickness of a piece of notebook paper. This thin, flexible combination of oily components is remarkably strong and forms a mechanical defense against skin irritants and bacterial infections while also helping to retain skin moisture. Persons who suffer from eczema have a defective skin barrier that allows higher levels of moisture to evaporate through their skin. This results in dry, cracked skin which sets off an inflammatory cascade leading to an itchy, scaly rash. The "scratch-itch" cycle leads to additional degradation of the skin's barrier, further exacerbating the disease. Epiceram(TM) contains a specific combination of oily ingredients which has been shown to form a barrier which replicates that found naturally in the skin. Dr. Peter Elias, a professor of dermatology at the University of California, San Francisco, the inventor of the "barrier repair" technology and Ceragenix's Chief Scientific Officer, has advocated the "barrier repair" approach in peer-reviewed journal articles as an alternative approach to alleviate the symptoms of eczema (atopic dermatitis).

According to Dr. Elias, "The standard therapy in the treatment of atopic dermatitis has long been dominated by topical steroids and more recently by immunosuppressive drugs. Long-term use of potent topical steroids may have significant adverse side effects. Use of the newer immunosuppressive drugs has been controversial Atopic dermatitis is a very common skin disease that afflicts over 15 million Americans. Consequently, there is a medical need for new approaches in the treatment of this disease. The data from this recent study is further corroboration of the research that our group at UCSF has been pursuing for the last 15 years."

Steve Porter, Chairman and CEO of Ceragenix stated: "We are very pleased with the results of this small but statistically significant study. We expect to submit our 510(k) application for Epiceram(TM) shortly."

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.


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.
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Publication:Business Wire
Date:Sep 15, 2005
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