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Both EpiCeram(R) and Elidel(R) Cream (pimecrolimus 1%) produced significant improvement in patients' conditions after four weeks of treatment
DENVER, CO, USA | May 20, 2008 | Ceragenix Pharmaceuticals Inc. (OTCBB:CGXP) today announced positive results from its investigator-blinded study comparing the safety and efficacy of EpiCeram(R) Skin Barrier Emulsion to that of Elidel(R) Cream (pimecrolimus 1%), a standard non-steroidal therapy in the treatment of mild-to-moderate pediatric atopic dermatitis (AD).
The study, which took place at two sites, consisted of 38 pediatric patients ages 2-12. The mean age was six years. Patients were randomized into two groups: one group received treatment with Elidel(R) cream (pimecrolimus 1%), and the second group received treatment with EpiCeram(R). The study demonstrated that:
Both EpiCeram(R) and Elidel(R) Cream produced significant improvement in patients' conditions after four weeks of treatment.
There were no statistically significant differences between the groups treated with EpiCeram(R) compared to those treated with Elidel(R) Cream as measured by EASI (Eczema Area and Severity Index) scores at Day 28 (the primary outcome measure). There was a statistically significant difference in median EASI score reduction at Week 2 with the Elidel(R) Cream group showing faster improvement at this timepoint. It is speculated that the slower response to EpiCeram(R) could be attributable to the relatively small amounts of EpiCeram(R) that were applied.
Improvement in patient AD as measured by Investigator Global Assessment (IGA) was a secondary endpoint of the study. Both treatments demonstrated a statistically significant reduction (pless than0.05) in IGA scores at weeks 2 and 4. Itching (pruritus), a hallmark symptom of AD, was another secondary endpoint of the study. Both EpiCeram(R) and Elidel(R) Cream produced significant relief from itching after 28 days of treatment, and there was no statistically significant difference between the two treatments in reduction of itching at this time point.
"The data from this study demonstrate that EpiCeram(R) is effective and offers the clinician and parents of children with atopic dermatitis a new approach for treatment of this skin condition without the risks often associated with long-term use of immunosuppressants," said Peter M. Elias, M.D., Professor of Dermatology at the University of California, San Francisco and Chairman of Ceragenix's Scientific Advisory Board.
The research was conducted by clinicians at the Oregon Health & Sciences University, Portland, OR, and the University of California School of Medicine, San Diego.
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 limitations of use due to various safety concerns. The use of EpiCeram(R) does not raise any of the safety concerns associated with the use of topical steroids or topical immunosuppressants.
Steve Porter, Chairman and CEO of Ceragenix stated, "We are very pleased with these results. EpiCeram(R) has demonstrated favorable results in treating symptoms of AD, and in key respects was not significantly different than a widely used immunosuppressant in treating the symptoms of atopic dermatitis after a 28 day treatment regimen. The study shows that EpiCeram(R) offers a novel approach to the therapy of atopic dermatitis based upon its barrier repair-based mechanism of action. EpiCeram(R) appears to be safe and effective in a substantial number of pediatric patients with mild to moderate AD, without the use of additional prescription drugs."
The investigators reported that a limitation of the pilot study was that the small sample size did not allow for robust statistical comparisons. They further state that further improvements may have been seen with a longer treatment time, and note that an intent-to-treat analysis was not performed.
Study Design
The study was an investigator-blinded, randomized controlled study conducted at two centers which evaluated a total of 38 patients in two groups of children (ages 6 months to 12 years) with mild-to-moderate atopic dermatitis treated with either Elidel(R) (pimecrolimus 1%), an immunosuppressant cream, or EpiCeram(R) a physiologic lipid-based barrier-repair cream. The study was conducted from April 2007 to January 2008.
Primary and Secondary Outcome Measures
According to the protocol, the primary outcome measure was the change in median EASI scores measured at Week 4 as compared to the baseline. The protocol's secondary efficacy parameters included:
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) as measured on a Visual Analog Scale.
Study Results
Primary Outcome Measure (change in median EASI score measured at Day 28 compared to Baseline).
Daily (twice) applications of Elidel(R) Cream produced significant reductions in EASI scores at Day 28 compared to baseline. While twice daily applications of EpiCeram(R) did not produce statistically significant improvement in EASI scores at Week 4, the overall improvement produced by EpiCeram(R) was not statistically significantly different from that produced by Elidel(R) (no significant difference between treatment effects after 28 days as measured by EASI).
Additionally, there were no statistically significant differences between EpiCeram(R) and Elidel(R) in the proportion of subjects with either greater than50% improvement in EASI score or greater than75% improvement in EASI scores at Week 4.
Key Secondary Outcome Measures
A. Percentage of subjects reaching clear or almost clear on IGA at Day 28 Both treatments demonstrated statistically significant reductions in AD symptoms as measured by Investigator's Global Assessment (IGA) at Week 4. Assessment of the disease progression showed significant improvements in the IGA scores over time with 27% of the EpiCeram(R) patients assessed as clear or almost clear after 28 days of treatment and 44% of the Elidel(R) Cream patients being assessed as clear or almost clear at Day 28. Comparison of these disease progression results for both treatments showed no statistically significant difference between EpiCeram(R) and Elidel(R) Cream after 28 days of treatment.
B. Assessment of Pruritus
Patient-reported assessments of pruritus also showed significant improvement from baseline after 28 days of treatment for both EpiCeram(R) and Elidel(R) Cream. No statistically significant differences were found between treatments after 28 days of treatment.
Safety
The investigators concluded that use of EpiCeram(R) is safe for use in the patient population studied. There were no serious adverse events reported in the study and both treatments had similar rates of adverse events.
About EpiCeram(R)
EpiCeram(R) is a prescription only therapy based on ceramide-dominant physiologic lipids which repair the natural barrier function of the skin. Its non-steroidal formulation has a very favorable safety profile and does not have the duration of use restrictions or pediatric patient age restrictions seen with other classes of prescription products. In a prior clinical study of 113 pediatric patients, EpiCeram(R) was highly effective as monotherapy in reducing clinical disease severity, and demonstrated comparable efficacy to fluticasone cream, a mid-strength steroid, at 28 days.
About Ceragenix
Ceragenix Pharmaceuticals, Inc. is a biopharmaceutical and medical device company focused on infectious disease and dermatology. The Company has two base technology platforms; Ceragenins(TM)or ("CSAs") 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 two prescription topical creams--EpiCeram(R) and NeoCeram(TM). EpiCeram(R) has been cleared for marketing by the United States Food and Drug Administration ("FDA") and the Company has entered into an exclusive supply and distribution agreement with Dr. Reddy's Laboratories, Inc. ("DRL") for the marketing and sales of the product in the United States. The Company anticipates that DRL will launch EpiCeram(R) during the second half of 2008. For additional information on Ceragenix, please visit www.ceragenix.com.
SOURCE: Ceragenix Pharmaceuticals, Inc. |
