DENVER, Sep 09, 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(TM)-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(TM) are a class of novel antimicrobial compounds that mimic functions of the body's own innate immune system. The Ceragenin(TM) 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(TM) 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."
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 secure additional funding by September 30, 2009, the ability of the Company to fund development of an oral drug beyond the term of the NIH grant whether internally or through a collaboration partner, the ability to successfully develop a product using the Ceragenin(TM) technology, the ability to successfully negotiate license terms if a product is successfully developed, 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.