DENVER, Jun 22, 2009 -- Ceragenix Pharmaceuticals, Inc. ("Ceragenix") (OTCBB:CGXP), a medical device company focused on infectious disease and dermatology, today announced that researchers at National Jewish Health, led by Dr. Donald Y. Leung and Dr. Michael Howell, in collaboration with Dr. Paul B. Savage of Brigham Young University, have demonstrated in a series of in vitro experiments and preclinical animal testing that an investigational drug compound known as CSA-13 shows promise as a potential therapy to treat viral infections from the vaccinia virus. The research appears ahead of print in an advanced online publication of the Journal of Investigate Dermatology, the official journal of the Society for Investigative Dermatology. This work was funded by the National Institute of Allergy and Infectious Diseases Atopic Dermatitis Vaccinia Network.
Vaccinia virus infections are of concern as the current smallpox vaccine uses this live virus to inoculate persons against a potential bioterror smallpox attack. Use of the vaccine is contraindicated in persons who are immunocompromised and in persons who have or ever had atopic dermatitis (eczema) as those persons are at greater risk for developing serious and sometimes life-threatening complications related to vaccinia infections. It is estimated that over 40 million persons are at higher risk of serious side effects if widespread smallpox vaccination were to be implemented.
CSA-13 is a member of the Company's developmental Ceragenin(TM) class of compounds. Ceragenins are synthetic antimicrobial compounds designed to mimic the structure and function of endogenous antimicrobial peptides which form a key component of the body's innate immune system. In the recent publication, the authors show that CSA-13 exhibits potent antiviral activity against the vaccinia virus by (1) direct antiviral effects against vaccinia; and (2) stimulating the expression of endogenous antimicrobial peptides with known antiviral activity against vaccinia. In addition, the research shows that a topical application of CSA-13 penetrates the skin and reduces subsequent satellite lesion formation.
According to Dr. Leung: "In our current study, we demonstrate that CSA-13 exhibits potent anti-viral activity by preferentially targeting and killing the vaccinia virus directly and by inducing antimicrobial peptides with known activity against the virus. Additionally, we demonstrate that topical administration of CSA-13 significantly reduces the development of satellite lesions. Taken together, our current study suggests that CSAs may be effective as an anti-viral agent against disseminated vaccinia virus infections. The development of these synthetic agents for treatment of disseminated viral skin infection represents an exciting advance."
Steve Porter, Chairman and CEO of Ceragenix, stated: "We thank Dr. Leung and his colleagues for his excellent work and his important findings on the anti-viral properties of our lead compound. Dr. Leung's group was the first to recognize the potential anti-viral properties of our Ceragenin(TM) compounds."
About Ceragenix
Ceragenix Pharmaceuticals, Inc. is a medical device company focused on infectious disease and dermatology. The Company has two base technology platforms: Ceragenins(TM) for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. Ceragenin(TM) compounds are active against a broad range of gram positive and negative bacteria. We have used our Ceragenin(TM) technology to formulate Cerashield(TM) antimicrobial coatings for medical devices. All Ceragenin(TM) and Cerashield(TM) products are currently in the developmental stage. Ceragenix's patented Barrier Repair technology, invented by Dr. Peter Elias, is the platform for the development of EpiCeram(R) which is currently being marketed by Promius Pharmaceuticals (a wholly owned subsidiary of Dr. Reddy's Laboratories) in the United States under an exclusive supply and distribution agreement. For additional information on Ceragenix, please visit www.ceragenix.com.
FORWARD-LOOKING STATEMENTS FOR CERAGENIX.
This press release may contain 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 operations and planned activities including completing development of its Ceragenin(TM) technology; the ability of the Company to meet its obligations under the supply and distribution agreement with Dr. Reddy's Laboratories including having sufficient working capital to fulfill purchase orders within the timeframes required by the agreement; the ability of the Company to service its outstanding convertible debt obligations; receiving the necessary marketing clearance approvals from the United States Food and Drug Administration (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, and a sufficient number of patients completing the studies; the ability of the Company to commercialize its planned products; the ability of the Company to successfully manufacture its products in commercial quantities (through contract manufacturers); 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, general economic conditions in the United States and elsewhere, and the Company's ability to hire, manage and retain qualified personnel. The aforementioned factors do 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 our forward-looking statements including general economic factors, business strategies, the state of capital markets, regulatory conditions, and other factors not currently known to us, may be significant, now or in the future, and the factors set forth in this press release may affect us to a greater extent than indicated. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in this press release and in other documents that we file from time to time with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2008, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K to be filed in 2009. Except as required by law, we do not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.