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Apr 24 2007, 7:00 AM EST

Ceragenix Announces Results from Phase IV Study of EpiCeram(TM) Meet All Primary and Secondary Endpoints

News source: Business Wire

Ceragenix Pharmaceuticals Inc. (OTCBB:CGXP) today announced positive results from its post-clearance marketing study comparing EpiCeram's(TM) efficacy to that of Cutivate(R) cream, a mid-strength topical steroid in the treatment of moderate-to-severe atopic dermatitis (AD).

The study, which took place at five centers, consisted of 113 pediatric patients, with 59 patients receiving treatment with Cutivate(R) and 54 patients receiving treatment with EpiCeram(TM). After 28 days of treatment, the study demonstrated that:

       Both EpiCeram(TM) and Cutivate(R) produced significant
       improvement in patients' conditions after 28 days of treatment;

       There were no statistically significant differences between the
       groups treated with EpiCeram(TM) compared to those treated with
       Cutivate(R) as measured by the SCORAD index at Day 28 (the
       primary outcome measure) or in the percentage of patients
       assessed to be "clear or almost clear" by physician assessment
       at Day 28 (a secondary outcome measure).

       Both EpiCeram(TM) and Cutivate(R) produced significant relief
       from itching (pruritus) and improvement in sleep habits after
       28 days of treatment and that there was no statistically
       significant difference between the two treatments in these
       measures at this time point (both secondary outcome measures).

"The data from this study demonstrate that EpiCeram(TM) is effective and offers both the clinician and parents a new approach for treating atopic dermatitis without the risks often associated with long-term use of topical steroids or immunosuppressants," said Lawrence Charles Parish, M.D., Clinical Professor of Dermatology and Cutaneous Biology at Jefferson Medical College of Thomas Jefferson University in Philadelphia, one of the study's principal investigators.

Atopic dermatitis is a chronic childhood skin condition that may affect patients for many years. Dermatology agents currently used to treat atopic dermatitis and other inflammatory skin disorders have important limitations and two commonly used immunosuppressants have been the subject of a controversial FDA imposed "black box" warning of a potential link between long term use and certain cancer risks. The use of EpiCeram(TM) does not raise any of the major safety concerns associated with the use of topical steroids and immunosuppressants.

Steve Porter, Ceragenix's Chairman and CEO stated, "We are very pleased with these results. We have just demonstrated that EpiCeram(TM) is comparable to a mid strength steroid in treating the symptoms of atopic dermatitis after a 28 day treatment regimen. We believe that EpiCeram has the potential to become the foundation of a new and improved paradigm in the treatment of this common childhood skin disorder which affects over 15 million Americans."

Study Design

The study was an investigator-blinded, randomized controlled study conducted at five centers which evaluated a total of 113 patients in two groups of children (ages 6 months to 18 years) with moderate-to-severe atopic dermatitis treated with either Cutivate(R) Cream, a mid-potency topical steroid, or EpiCeram(TM). The study was primarily conducted during the winter months of December ('06), January ('07) and February ('07).

Primary and Secondary Outcome Measures.

According to the protocol, the primary outcome measure was the change in mean SCORAD score measured at Day 28 as compared to the baseline. The protocol's secondary efficacy parameters were:

       a) Percentage of subjects reaching clear or almost clear on
          Investigator's Global Assessment (IGA) at Day 28;
       b) Change in patient reported assessments of pruritus (itch);
          and
       c) Change in patient reported assessment of dis




	
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