DENVER, June 28, 2005 (PRIMEZONE) -- Ceragenix Pharmaceuticals, Inc. ("Ceragenix" or the "Company") (OTCBB:CGXP) today announced that Dr. Paul B. Savage, professor of Chemistry and Biochemistry at Brigham Young University, presented data in two poster presentations from in-vitro studies on Ceragenix's Cationic Steroid Antibiotic technology at the National Foundation for Infectious Disease's annual meeting on Antimicrobial Resistance on June 27th in Bethesda, Maryland (www.nfid.org).
Data presented by Dr. Savage included the results of two in-vitro studies which examined the activity of Ceragenix's lead compound -- CSA-13 -- against (1) vancomycin-resistant infections, including vancomycin-resistant staphylococcus aures (VRSA) and vancomycin-resistant enterococci (VRE); and (2) tobramycin-resistant pseudomonas infections in clinical isolates from patients with cystic fibrosis.
Vancomycin is now a common therapy to treat the growing number of methicillin-resistant Staphylococcus aureus ("MRSA") cases found in many hospitals around the world. In the last few years, strains of MRSA that are fully resistant to vancomycin have been isolated and clinicians fear that it is only a matter of time before more strains of MRSA develop vancomycin resistance leading to even greater morbidity and mortality. Testing against the vancomycin-resistant strains of staphylococci and enterococci was performed by Dr. Peter Appelbaum's laboratory at Hershey Medical Center and showed excellent activity against all strains of VRSA and all but one strain of VRE. Mininum inhibitory concentration (MIC) values against the three strains of fully resistant VRSA were all under 0.25 micrograms/ml and the same values were obtained against vancomycin intermediate resistant strains (VISA). MIC values against vancomycin-resistant faceium strains were all under 0.5 micrograms/ml. Copies of the poster presentations are available on the Ceragenix website (www.ceragenix.com).
The second poster presentation presented data on CSA-13's in-vitro efficacy against strains of pseudomonas infections isolated from cystic fibrosis patients (courtesy of Dr. Jane Burns, University of Washington) that are highly resistant to Tobramycin, the antibiotic commonly used to treat such infections. Persistent pseudomonas infections are the leading cause of morbidity and mortality in patients with cystic fibrosis. CSA-13 was tested against a standard strain of pseudomonas and strains obtained from cystic fibrosis patients that ranged from moderate resistance (MIC values of 4 to 20 micrograms/ml), as well as highly resistant Tobramycin strains (MIC values over 80 micrograms/ml). CSA-13 showed potent activity against all strains with MIC values ranging from 0.8 micrograms/ml to 3 micrograms/ml. The development of a new antibiotic with low toxicity and high efficacy against such multi-drug resistant strains would be an important advance in clinical therapy.
According to Steven Porter, chairman and CEO of Ceragenix, "We are committed to the development of these promising compounds as we believe that the CSAs offer a new approach to overcoming the looming worldwide threat of antibiotic resistant bacterial infections."
The Company believes that its Cationic Steroid Antibiotic (CSA) technology has particular promise in the battle against multi-drug resistant bacteria as it is less likely to induce the development of new resistant strains and is not likely to be subject to bacterial defenses such as efflux pumps or protease degradation. The CSAs mimic the bacteriocidal activity of our own naturally occurring antimicrobial peptides, known as defensins and cathelicidins, which form part of our innate immune system. Worldwide research has shown that these peptides are common in insects, birds, amphibians, and mammals and play a critical role in defending against bacterial and viral infections.
About Ceragenix
Ceragenix is a development-stage healthcare company focused on dermatology, infectious diseases, and oncology. 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(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, and other common skin disorders. The Company's patented Cationic Steroid Antibiotic (CSA) 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), 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 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 sufficient capital to finance its planned activities, 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.