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Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints

aseline after 28 days of treatment for both EpiCeram(TM) (2.63 change from baseline) and Cutivate(R) cream (2.81 change from baseline). No statistically significant differences were found between treatments after 28 days of treatment.

Safety

The investigators concluded that use of EpiCeram(TM) was safe for use under the conditions of the study. There were no serious adverse events reported in the study and all but one of the reported adverse events either mild or moderate and all were consistent with the symptoms of atopic dermatitis. The investigators recommended that four EpiCeram(TM) patients experiencing adverse events temporarily discontinue use of the product. Two of these patients fully resolved. The investigators made no recommendation that any of the Cutivate(R) patients discontinue use.

About EpiCeram(TM)

EpiCeram(TM) is a prescription only product intended for use to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses including atopic dermatitis (eczema), irritant contact dermatitis, and radiation dermatitis. In April 2006, we received marketing clearance from the FDA to sell EpiCeram(TM) as a medical device pursuant to a 510(k) filing. Unlike steroids and immunomodulators, both of which have well recognized undesirable side effects and usage restrictions, EpiCeram(TM)'s non-steroidal formulation has a very favorable safety profile and does not have the duration of use restrictions or pediatric patient age restrictions of these other classes of prescription products. Immunomodulator drugs used for treating atopic dermatitis recently received a black box safety warning from the FDA.

About Ceragenix

Ceragenix Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops and commercializes novel anti-infective drugs based on its proprietary class of compounds, Ceragenins(TM) (or CSAs). Active against a broad range of gram positive and
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