Centers for Disease Control and Prevention (CDC) and Ceragenix Enter into a Cooperative Research and Development Agreement (CRADA).DENVER -- CRADA CRADA Cooperative Research And Development Agreement to Evaluate the Efficacy of Ceragenix's Ceracide(TM) Antimicrobial Coating in the Prevention of Bacterial Biofilm Biofilm An adhesive substance, the glycocalyx, and the bacterial community which it envelops at the interface of a liquid and a surface. When a liquid is in contact with an inert surface, any bacteria within the liquid are attracted to the surface and adhere Growth on Medical Devices Ceragenix Pharmaceuticals, Inc. ("Ceragenix" or the "Company"), a development stage biopharmaceutical company, today announced that it has entered into a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. ("CRADA") with the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. ("CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ") to evaluate the efficacy of Ceragenix's Ceracide(TM) antimicrobial coating for the prevention of bacterial biofilm growth on medical devices. The Company had previously announced entering into a letter of intent with the CDC on this project. "This collaboration with the CDC illustrates the progress we continue to make with our infectious disease program," said Steven Porter, Chairman & 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. "Working with the CDC will strengthen our pursuit of an effective long-lasting antimicrobial coating for medical devices." A biofilm is a slime-like multicellular mul·ti·cel·lu·lar adj. Having or consisting of many cells. mul ti·cel bacterial colony that may form when bacteria attach to medical devices such as catheters, vascular grafts or endotracheal tubes. Biofilms may cause infections that are resistant to conventional antibiotics. These infections are of significant medical concern. According to the CDC, infections associated with central venous catheters account for 250,000 cases of blood stream infections annually. The attributable mortality for such infections is estimated to range between 12 percent to 25 percent and the annual costs of caring for patients with central venous catheter infections may be as high as $2.3 billion. The CRADA's research plan will evaluate Ceragenix's Ceracide(TM) antimicrobial coating using the CDC's Biofilm Reactor, a specially designed device that is able to reproducibly grow biofilms in an environment mimicking the body conditions under which bacteria form such films, including fluid turbulence. Dr. Rodney Donlan, team leader of the CDC's Biofilm Research Laboratory, devised the protocol for testing and will assist in the evaluation of the results. The testing will be conducted by Dr. Paul B. Savage's laboratory at Utah-based Brigham Young University Brigham Young University, at Provo, Utah; Latter-Day Saints; coeducational; opened as an academy in 1875 and became a university in 1903. It is noted for its law and business schools. ("BYU"). Dr. Savage is a Professor of Chemistry and Biochemistry at BYU and the inventor of the Ceracide(TM) technology that BYU has exclusively licensed to Ceragenix. BYU is also a party to the CRADA. 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 (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 serious 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 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 and may also be of importance in HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. related skin dermatoses. Ceragenix has submitted a 510K to 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. seeking marketing clearance to commercialize this technology in 2006. 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 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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