Ceragenix awarded $2.87M NIH grant to develop a drug for treating Clostrdium difficile and Shigella

www.ceragenix.comSep 9 2009

Ceragenix Pharmaceuticals, Inc. (“Ceragenix”) (OTCBB:CGXP), a medical device company focused on infectious disease and dermatology, today announced that the National Institutes of Health (“NIH”) has awarded a $2.87 million grant to fund the pre clinical development of a Ceragenin™based oral drug to treat two common and potentially deadly gastrointestinal infections: Clostrdium difficile and Shigella. The grant will fund the preclinical development, formulation, toxicology and cGMP scale up to 1 kilogram of CSA-13. The research grant has been awarded to a consortium of research institutions led by Brigham Young University (“BYU”) and including SRI International (Menlo Park, CA), Southwest Research Institute (SwRI, San Antonio, TX) and McMaster University (Hamilton, Ontario, Canada). Ceragenins™ are a class of novel antimicrobial compounds that mimic functions of the body’s own innate immune system. The Ceragenin™ technology was invented by Dr. Paul B. Savage (Reed Izatt Professor at BYU) and has been exclusively licensed by BYU to Ceragenix. There have been over 30 peer reviewed scientific publications on this novel class of compounds.

C. difficile is now responsible for approximately 3 million cases of diarrhea and colitis annually in the United States, and has a mortality rate of 1%-2.5%. Reported mortality rates from C. difficile-associated disease in the United States increased approximately four fold between 1999 and 2004. Shigellosis is a common childhood infectious disease caused by a group of bacteria called Shigella. Most who are infected with Shigella develop diarrhea, fever, and stomach cramps starting a day or two after they are exposed to the bacterium. Shigellosis usually resolves in 5 to 7 days. In some persons, especially young children and the elderly, the diarrhea can be so severe that the patient needs to be hospitalized. A severe infection with high fever may also be associated with seizures in children less than 2 years old. An estimated 300,000 cases of Shigella infection occur each year in the United States and the prevalence is much higher in the developing world. The National Institute for Allergy and Infectious Disease (NIAID) has listed Shigella as a potential bioterror weapon.

Steve Porter, Chairman and CEO of Ceragenix stated, “We are very pleased that the NIH sees potential in our technology as an oral drug to treat these dangerous infections. This represents the second NIH grant awarded this year to researchers who are pursuing the development of the Ceragenin™ technology. In addition to the research being funded by the NIH, we continue to make excellent progress in our development efforts for use of this technology to provide an antimicrobial coating for medical devices to help reduce the incidence of hospital acquired infections. We believe that the NIH funded research activities will be synergistic with our development efforts on antimicrobial medical device coatings.”