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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 OTCBB

See OTC Bulletin Board (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 The Regents of the University of California make up the governing board of the University of California. The Board has 26 full (i.e., voting) members:
  • The majority (18 Regents) are appointed by the Governor of California for 12-year terms.
. In this small but statistically significant study conducted by AMA (Automatic Message Accounting) The recording and reporting of telephone calls within a telephone system. It includes the calling and called parties and start and stop times of the call.  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 TEWL Transepidermal Water Loss (skin barrier property) ) 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 Epidermal
Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin).

Mentioned in: Antiangiogenic Therapy, Histiocytosis X


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 Coordinates:  , 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 UCSF University of California at San Francisco  has been pursuing for the last 15 years."

Steve Porter, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). , 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 irritant contact dermatitis Occupational dermatology A form of CD that usually affects the hands and arms, caused by acids, alkalis; the intensity of skin response reflects intrinsic nature of the chemical, its concentration, and duration of contact Clinical  and other common skin disorders. The Company's patented Cationic cationic

having qualities dependent on having free cations available.


cationic detergents
are wetting agents that disrupt or damage cell membranes, denature proteins and inactivate enzymes.
 Steroid Antibiotic (CSA (1) (Canadian Standards Association, Toronto, Ontario, www.csa.ca) A standards-defining organization founded in 1919. It is involved in many industries, including electronics, communications and information technology. ) 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 MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ), 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 15, 2005
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