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Cutanea Announces Promising Phase II Results in Rosacea with Omiganan
Date:10/17/2007

Plans to Move Forward with Phase III

MALVERN, Pa., Oct. 17 /PRNewswire/ -- Cutanea Life Sciences, an emerging specialty pharmaceutical company focused on improving human health and appearance through the development and commercialization of treatments for diseased and aging skin conditions, today announced results from its completed Phase II clinical trial of Omiganan.

The trial compared Omiganan 2.5% and 1% topical gel to vehicle in subjects with papulopustular rosacea. Study results demonstrated that the formulation was safe and well-tolerated at all doses tested. Among the once-daily treatment arms, a dose-dependent response was observed in both lesion reductions and Treatment Success, as defined by Investigator Global Assessment (IGA) scores. After nine weeks of treatment, once-daily (QD) Omiganan 2.5% gel showed superior lesion count reductions and Treatment Success, compared to 1% Omiganan QD and vehicle. Omiganan provided greater improvements compared to vehicle among patients with a more severe condition at Baseline (more numerous inflammatory lesions). Lesion counts continued to drop at all evaluations over the duration of the study, indicating that further improvements may be expected with a duration of treatment exceeding nine weeks. Twice daily (BID) application of 2.5% Omiganan did not demonstrate substantial improvement in lesion reduction or the number of patients reaching Treatment Success compared to once daily application. Based on the results from this study, Cutanea has selected a once-daily dose of Omiganan 2.5% for further development for the treatment of papulopustular rosacea.

Dr. Guy Webster, Founding and Current President of the American Acne & Rosacea Society and Clinical Professor of Dermatology at Jefferson Medical College stated, "Topical Omiganan is a novel approach, actually the first in a new class of dermatologic drugs, for the treatment of rosacea. Initial results are promising and I look f
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SOURCE Cutanea Life Sciences
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