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Vanderbilt University, Brigham Young University, and Ceragenix Pharmaceuticals Report Novel Drug Compound Kills Multiple HIV Strains; Synthetic Small Molecule Acts Through Unique Strain-Independent Virucidal Mechanism

NASHVILLE, Tenn. & PROVO, Utah & DENVER, Feb 6, 2006 -- Vanderbilt University, Brigham Young University and Ceragenix Pharmaceuticals, Inc. today announced that one of a family of compounds, called Ceragenins (or CSAs) shows potent virucidal activity in in vitro laboratory tests against multiple strains of Human Immunodeficiency Virus (HIV), the virus that causes AIDS.

CSAs were invented by Dr. Paul D. Savage of Brigham Young University's Department of Chemistry and Biochemistry and exclusively licensed to Ceragenix. In data previously presented by Dr. Savage and other researchers, CSAs have been shown to have broad spectrum antibacterial activity. Dr. Derya Unutmaz, Associate Professor of Microbiology and Immunology at the Vanderbilt University School of Medicine, tested several CSAs in his laboratory for their ability to kill HIV directly.

"We found that CSA-54 potently inhibits HIV infection of primary human CD4+ T cells, the virus's in vivo targets, and was not toxic to epithelial cells at concentrations significantly higher than those required to kill the virus," stated Dr. Unutmaz. "In addition, CSA-54 killed a wide range of HIV isolates, and completely blocked genetically engineered HIV that enters the cells independent of the cell surface receptor the virus normally uses. This finding indicates that CSA-54 likely attacks the viral membrane and disrupts the virus from interacting with its target cells, similar to some of the known microbicidal peptides.

This is particularly important as a compound that targets the viral membrane is likely to be effective against all strains of the virus, regardless of mutations as the viral membrane remains unchanged."

"We are encouraged, based on these early in vitro studies, that CSAs may provide a completely unique family of anti-infectives, potentially active against a wide range of viral, fungal, and bacterial targets, including those resistant to current therapies," stated Steven Porter, CEO of Ceragenix. "Given the potent activity of CSA-54 against all strains of HIV tested, we plan on exploring the use of this compound in both topical and systemic applications for HIV therapy."



Ceragenix(TM) Compound Shows Promise for Treating Lethal Cystic Fibrosis Infections

Testing Performed at the University of Pennsylvania's Institute of Medicine and Engineering

DENVER, Jul 2, 2007 -- Ceragenix Pharmaceuticals, Inc. (CGXP), a biopharmaceutical company focused on infectious disease and dermatology, today announced that researchers at the University of Pennsylvania led by Dr. Paul Janmey and Dr. Robert Bucki, in collaboration with Dr. Paul B. Savage of Brigham Young University, have demonstrated in a series of in vitro experiments that an investigational drug compound known as CSA-13 shows promise as a potential therapy to treat multidrug resistant Pseudomonas aeuroginosa infections which are a leading cause of morbidity and mortality in patients with cystic fibrosis. The research appears ahead of print in an advanced online publication of the Journal of Antimicrobial Chemotherapy, the official journal of the British Society for Antimicrobial Chemotherapy.

In the reported research, Dr. Bucki and his colleagues evaluated the activity of a CSA-13, a member of the family of Ceragenin(TM) compounds being developed by Ceragenix. CSA-13 is a synthetic non-peptide mimic of the naturally occurring antimicrobial peptide found in the lung. The researchers found that CSA-13:

-- Is significantly more effective than positively charged antibacterial peptides (LL-37) against a multidrug resistant strain of Pseudomonas aeuroginosa;

-- Is far less susceptible to inactivation by negatively charged components found in the sputa of cystic fibrosis patients (DNA and F-actin); and that

-- Is potent even in cystic fibrosis sputum thereby suggesting potential for therapeutic use.

"This new compound has the potential to be a significant advance in the treatment of patients with cystic fibrosis and other lung infections," says senior author Robert Bucki, a Senior Investigator at the University of Pennsylvania's Institute for Medicine and Engineering.

Normal healthy lungs are protected against bacterial infection by the presence of naturally occurring antimicrobial peptides such as LL-37 found in the lung fluid which form part of the body's innate immune system. These positively charged antimicrobial peptides are electrostatic attracted to the negatively charged membranes of bacteria. Once attached to the invaders' membranes, the antimicrobial peptides permeabilize and destroy the bacterial membranes leading to bacterial cell death. This highly effective mechanism of protecting the lung from bacterial infection does not work well in patients with cystic fibrosis as those patients have much higher levels of other negatively charged components in their sputum which bind to and inactivate the antimicrobial peptides. As a result, patients with cystic fibrosis are at high risk for lung infections throughout their lifetimes and the repeated bouts of lung infections scar the lung tissue and ultimately rob the patients of their ability to breathe.

"The conventional therapy used to treat Pseudomonas infections in cystic fibrosis patients is Tobramycin but there are an increasing number of Tobramycin resistant strains of Pseudomonas. There is an urgent need for the development of new antibiotics to treat these and other gram-negative bacterial infections," said Steven Porter, Chairman and CEO of Ceragenix Pharmaceuticals. "Our goal is to find a partner to help us advance development of this application."



Results of Pre-Clinical Investigation of Ceragenix's Developmental Antibiotic to Prevent Sepsis Presented at International Scientific Meeting

DENVER, Oct 22, 2007 -- Ceragenix Pharmaceuticals, Inc. (OTCB:CGXP), a biopharmaceutical company focused on infectious disease and dermatology, today announced that researchers at the Johns Hopkins Burn Center presented data in a late-breaking poster presentation on use of systemically administered CSA-13 to prevent the development of sepsis in rats that had been exposed to endotoxin. The data was presented at the recent 40th annual meeting of the Society for Leukocyte Biology held in Boston, Massachusetts in a poster entitled "CSA-13 suppresses endotoxin shock induced by LPS in neonatal rats."

Sepsis is a leading cause of death among patients admitted to the hospital. There are over 750,000 cases of sepsis annually in the United States and over 200,000 deaths. Sepsis is of particular concern in patients with extensive burn injuries as they are at high risk of significant morbidity and death. The development of "sepsis" or "endotoxin shock" is related to the presence of lipopolysaccharides (LPS) on the cell wall of gram-negative bacteria (such as Pseudomonas aeuroginosa or E. Coli) or lipotechoic acid (LTA) on the cell wall of gram-positive bacteria (such as MRSA). The release of this toxin by the bacteria may lead to a cascade of inflammatory reactions resulting in organ failure and death. Prior published work had shown that CSA-13 (one of Ceragenix's lead compounds in the class of Ceragenin(TM) compounds) has very high binding affinity for LPS. In these series of experiments, the researchers evaluated whether injection of CSA-13 into rats might be able to reduce the mortality associated with endotoxin shock.

In these experiments 13-15 day old neonatal rats (Wistrar), were sensitized to LPS by injecting D + galactosamine (600 mg/kg). Control and treatment groups both received LPS (150 (mu)g/kg), whereas the treatment group received CSA-13 (6.5 mg/kg; i.p) 30 min prior to LPS. In the control group mortality was 100% at 24 hours contrasting with the treatment group in which 80% of the rats were still alive at 72 hours. Similar results were also obtained by pre-mixing LPS with CSA-13 (1:4 concentrations) prior to injection.

According to Carl Genberg, Senior Vice President of Research and Development of Ceragenix, "This significant improvement in mortality (p is less than 0.001) demonstrates that LPS neutralizing properties of CSA-13 may be effective in preventing endotoxin shock. Therefore, the combination of antibacterial action and LPS neutralization may render CSA-13 a novel drug candidate in prevention and treatment of septic shock."

Steven Porter, Chairman and CEO of Ceragenix stated, "Sepsis kills thousands of Americans annually and brings untold pain and suffering to affected patients and the family members. These preclinical results, especially when combined with our previous disclosures regarding the preclinical efficacy of CSA-13 against MRSA, VRSA and other resistant strains, are highly encouraging."

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Ceragenix Pharmaceuticals, Inc.

I don't think this company is a big money maker. and as a matter of fact, I think if someone buys it, they ought to be careful about selling it so that it doesn't go to the big pharm corps.

But it's a neat story. besides the fact that this compound looks potentially able to kill all virus and bacteria>> DISEASE! in the world....the stock part of the story is this>>this used to be a small bingo supply company out of Alaska. The mormons at brigham young (same dudes who started the outlawing of mary in the US)...the mormons gave this synthetic drug to this bingo company to oversee it's development. They've been at it for a couple of years now and already have it in use as part of a skin creme. the bingo company (ceragenix) issued 1 million shares of stock. the board owns 10% of that and the rest is public. it sells for a little over $2 USD.