BALLERUP, Denmark, Feb. 1 /PRNewswire-USNewswire/ -- LEO Pharma today announced that in a Phase III study, PEP005 (ingenol mebutate) Gel, the company's lead candidate for the topical treatment of actinic (solar) keratosis (AK) or pre-cancerous lesions, met its primary clinical endpoint of complete clearance of AK lesions in non-head locations. Findings from the REGION Ib study in body AK support results from the earlier REGION-I trial, a study evaluating PEP005 for the treatment of AK on the head reported in December 2009.
"PEP005 is a recent addition to LEO Pharma's robust dermatology pipeline. We could not be happier with the preliminary findings that suggest PEP005 may be a promising new treatment option for patients with this type condition, a pre-cursor to skin cancer," said Lars Olsen, Executive Vice President for Research & Development, LEO Pharma.
Approximately 250 patients were enrolled in the REGION Ib study, which evaluated the use of a 0.05% concentration of PEP005 Gel applied daily as monotherapy for two consecutive days to AK lesions on non-head locations.
Results from REGION I and Ib will be presented at an upcoming meeting of the American Academy of Dermatology.
About Actinic Keratosis
Actinic keratosis (AK) is a common pre-cancerous skin condition caused by sun exposure, which can develop into skin cancers if left untreated. The number of AK patients is both large and rapidly growing, and AK is a serious health problem.
With a strong portfolio of approved products and a robust pipeline of treatments in development for conditions including psoriasis, eczema and actinic (solar) keratosis, LEO Pharma is one of the leading dermatology companies in the U.S. and the world.
LEO Pharma
