Ceragenix Completes Patient Visits for EpiCeram(TM) Clinical Study.Study to Evaluate Efficacy of New, Non-Steroidal Treatment for Eczema DENVER -- Ceragenix Pharmaceuticals  This article or section is written like an .Please help [ rewrite this article] from a neutral point of view. Mark blatant advertising for , using . , Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :CGXP), 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 reported it has completed the patient visit phase of its clinical study evaluating the efficacy of the company's EpiCeram in comparison to a mid-strength topical steroid in treating 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 study took place at five sites and consisted of 112* children between the ages of 6 months and 18 years. Over a four-week period, half of the subjects used EpiCeram while the other half used Cutivate[R], a mid-strength topical steroid. The objective of the single blinded study was to assess EpiCeram's efficacy as a stand-alone treatment for the symptoms of eczema in children with moderate to severe disease in comparison to a mid-strength steroid. The company expects to receive the final study report and announce the study results sometime between the end of March and mid-April. "Successfully completing the patient evaluation phase of this study represents another major milestone in the advancement of EpiCeram," noted Steven Porter Dr. Steven Porter (born 1943), BS MA PhD PD, is currently a candidate for the Third Congressional District of Pennsylvania. He is a teacher and composer, and in 1968 he became involved with politics when he helped Robert Kennedy in his presidential election campaign. , Ceragenix's 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. . "Based on presentations at the recent American Academy of Dermatology The American Academy of Dermatology (AAD) is the largest organization of dermatologists in the world. The Academy grants Fellowships and Associate Memberships, as well as Fellowships for Nonresidents (of the United States of America or Canada). conference, it appears a paradigm shift A dramatic change in methodology or practice. It often refers to a major change in thinking and planning, which ultimately changes the way projects are implemented. For example, accessing applications and data from the Web instead of from local servers is a paradigm shift. See paradigm. is taking place regarding the importance a defective skin barrier plays in the pathogenesis of diseases like eczema. If EpiCeram can demonstrate relatively good efficacy as compared to a mid-strength steroid, we believe it will be well received by prescribing physicians, particularly pediatricians and dermatologists. It will also aid our ongoing efforts to partner with a pharmaceutical company experienced in marketing dermatology products." About EpiCeram EpiCeram is intended for use to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis (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 radiation dermatitis radiation dermatitis n. See radiodermatitis. . All of these conditions share in common a defective or incomplete skin barrier. In April 2006, we received marketing 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 sell EpiCeram as a medical device pursuant to a 510(k) application. Unlike steroids and immunomodulators, both of which have well recognized undesirable side effects Side effects Effects of a proposed project on other parts of the firm. and usage restrictions, EpiCeram is completely safe and without usage restrictions. Immunomodulator drugs used for treating atopic dermatitis recently received a black box safety warning from the FDA. About Ceragenix Ceragenix Pharmaceuticals, Inc. 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 also 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 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]. 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; the ability of the Company to satisfy its outstanding convertible debt obligations; 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. ; 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; 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[TM]; 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 2007. 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. * Reflects the number of patients who completed the study. The number of patients included in the final study report is subject to change as a result of auditing the data and protocol compliance. |
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