Ceragenix Pharmaceuticals Initiates EpiCeram(R) Clinical Trial; EpiCeram(R) to be Compared to Mid-Strength Steroid in Children with Moderate-to-Severe Eczema.DENVER -- Ceragenix Pharmaceuticals Please help [ rewrite this article] from a neutral point of view. Mark blatant advertising for , using . , Inc., a biopharmaceutical company focused on infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. and dermatology, today announced that it has begun enrolling patients in a multicenter pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. clinical study designed to assess the efficacy of EpiCeram(R) compared to Cutivate(R), a commonly prescribed mid-strength steroid, in patients with moderate-to-severe atopic dermatitis Atopic Dermatitis Definition Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and (eczema). The Company expects to report results of this trial in the fourth quarter of 2006. The study will consist of 90 children between the ages of 6 months and 18 years of age. 45 children will receive treatment with EpiCeram and 45 will receive treatment with the steroid for a 4-week period. The objective of the study is to determine whether Epiceram can be as effective as a mid-strength steroid in both restoring a more normal skin barrier (as measured by trans-epidermal water loss) and treating the symptoms associated with eczema (e.g. itching, inflammation, etc.). The study is being conducted at two private dermatology practices in Trenton, New Jersey and Santa Rosa, California Santa Rosa is the county seat of Sonoma County, California, USA. As of January 1 2007, the population of Santa Rosa was approximately 157,985 residents. Santa Rosa is the largest city in California's Wine Country and fifth largest city in the San Francisco Bay Area, after San . In April 2006, Ceragenix received 510(k) clearance from 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. to market EpiCeram to improve dry skin conditions and to relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis, 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 , radiation dermatitis radiation dermatitis n. See radiodermatitis. , and other dry skin conditions by maintaining a moist wound and skin environment. EpiCeram, a new prescription-only topical cream, is based on the Company's Barrier Repair Technology invented by Dr. Peter Elias and licensed by Ceragenix 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). . EpiCeram is a non-steroidal treatment for dry skin conditions, consisting of a proprietary formulation of ceramide, cholesterol and free fatty acids in a specific optimized ratio that helps restore a healthy skin barrier. "We are pleased to announce achieving this milestone and look forward to the results in the coming months," stated Steven 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. "If EpiCeram proves to be as efficacious as a mid-strength steroid, we believe it will be well received by pediatricians and dermatologists. Topical steroids and immunosuppressants immunosuppressants, n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents; represent the majority of the estimated $1 billion market for treating eczema in the U.S. EpiCeram is neither a steroid nor an immunosuppressant immunosuppressant /im·mu·no·sup·pres·sant/ (-sah-pres´ant) an agent capable of suppressing immune responses. im·mu·no·sup·pres·sant n. An agent that suppresses the body's immune response. . As a result, EpiCeram should not present the same concerns associated with both of these treatments, including the recent Black Box warning the FDA now requires on immunosuppressants. As previously disclosed, we plan to commercialize EpiCeram by partnering with a large pharmaceutical company with experience in marketing dermatology products and those discussions are currently underway." About Ceragenix Ceragenix Pharmaceuticals, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : CGXP) is a biopharmaceutical company that discovers, develops and commercializes novel anti-infective drugs based on its proprietary class of compounds, Ceragenins(TM) (or CSAs). Active against a broad range of gram positive and negative bacteria, these agents are being developed as anti-infective medical device coatings (Ceracides(TM)) and as therapeutics for antibiotic-resistant organisms. Ceragenix further owns exclusive rights to Barrier Repair Technology for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. 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(R) and NeoCeram(R). For additional information on Ceragenix, please visit www.ceragenix.com. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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 sufficient capital to finance its planned activities, receiving the necessary marketing clearance approvals from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (the "FDA"), successful clinical trials of the Company's planned products including; the ability to enroll the studies in a timely manner, patient compliance with the study protocol, a sufficient number of patients completing the studies, and the ability to demonstrate the equivalence of EpiCeram(R) to a mid strength steroid , the ability of the Company to commercialize its planned products, the ability of the Company to consummate a favorable marketing agreement with a partner to market EpiCeram(R), market acceptance of the Company's planned products, the Company's ability to successfully develop its licensed compounds, alone or in cooperation with others, into commercial products, the ability of the Company to successfully prosecute and protect its intellectual property, and the Company's ability to hire, manage and retain qualified personnel. The aforementioned factors do not represent an all inclusive list. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained in this press release. In particular, important factors that could cause actual results to differ materially from the Company's forward-looking statements include general economic factors, business strategies, the state of capital markets, regulatory conditions, and other factors not currently known to the Company, may be significant, now or in the future, and these factors may affect the Company to a greater extent than indicated. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in this press release and in other documents that the Company files from time to time with the Securities and Exchange Commission including its Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and Current Reports on Form 8-KSB to be filed in 2006. Except as required by law, the Company does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. |
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