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

p=0.012 for per protocol populations). While in this exploratory study this endpoint was identified as a secondary end point, FDA currently requires the absolute change (rather than percent change) in the number of inflammatory lesions as one of the co-primary endpoints, along with Treatment Success, for demonstrating efficacy in a Phase III trial in rosacea.

"Based on these encouraging results, we have selected once-daily Omiganan 2.5% for further study in rosacea, which is a critical step towards potential commercialization, either directly or in collaboration with a partner," commented Robert J. Bitterman, President and CEO of Cutanea.

About Rosacea

Rosacea is a chronic dermatologic disorder with no current cure and a poorly understood etiology that afflicts an estimated 14 million Americans. Symptoms primarily manifest on the facial skin and include facial flushing, central facial inflammatory lesions, and facial erythema. According to surveys conducted by the National Rosacea Society (NRS), nearly 70% of rosacea patients said the disorder had lowered their self-confidence and self-esteem; 41% reported it had caused them to avoid public contact or cancel social engagements; and nearly 30% claimed to have missed work due to rosacea. Of these rosacea patients surveyed by the NRS that sought medical treatment, over 70 percent reported an improvement in their emotional and social well-being.

Typical onset of rosacea occurs between 30 and 50 years of age and is more prevalent in women than men. Clearing up the initial outbreak is only the beginning, as rosacea is characterized by periods of relapses and remissions. Relapse episodes can be spurred by sun exposure, stress, hot or cold weather, alcohol, spicy foods, exercise, and certain skin care products and medications.

Absent a cure for rosacea, treatment is aimed at alleviating the disorder's symptoms. Topical or oral medications are generally prescribed for mild to moderate papulopus
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SOURCE Cutanea Life Sciences
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