Ceragenix Completes Patient Visit Phase of Clinical Trial Study to Compare Efficacy of EpiCeram to ElidelDENVER--(BUSINESS WIRE)--Mar 13, 2008 - Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP) (the "Company"), a biopharmaceutical and medical device company focused on infectious disease and dermatology, today announced that it had completed the patient visit phase of its previously announced clinical trial to assess the safety and efficacy of EpiCeram(R) relative to Elidel(R) in treating the symptoms associated with eczema such as itch and redness as measured by the EASI scoring system. Elidel is the leading immunosuppressant topical therapy for the short-term treatment of atopic dermatitis. The randomized, double blind study consisted of children between the ages of 2 and 18 years and was conducted at two academic sites. For a four-week period, half of the subjects received treatment with EpiCeram(R) and the other half received treatment with Elidel(R). While the study had a goal of enrolling at least 50 patients, study enrollment was terminated at 36 patients as the rate of enrollment at the two sites did not anticipate timely completion of the full cohort of patients. The study results are currently undergoing statistical analysis and the Company expects to receive the final study report during the second quarter of 2008 at which time it will announce the results.
Ceragenix Pharmaceuticals, Inc. is a medical device company that develops and commercializes novel anti-infective treatments for indwelling medical devices based on its proprietary class of compounds, Ceragenins(TM) (or CSAs). These compounds are active against a broad range of gram positive and negative bacteria. Ceragenix also owns exclusive rights to Barrier Repair Technology for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. 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(R) and NeoCeram(TM). For additional information on Ceragenix, please visit www.ceragenix.com.
FORWARD LOOKING STATEMENTS
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 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, but not limited to, delivering shelf stable product prior to the planned launch; the ability of the Company to satisfy its outstanding convertible debt obligations; receiving the necessary marketing clearance approvals from the United States Food and Drug Administration; 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, 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-KSB for the year ended December 31, 2006, Quarterly Reports on Form 10-QSB and Current Reports on Form 8-K to be filed in 2008. 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.
CEOcast, Inc. for Ceragenix
Dan Schustack, 212-732-4300
Posted: March 2008