Phase 3 study of PEP005 gel for treatment of actinic keratoses

Peplin announced the completion of enrollment of its two Phase 3 trials for the use of PEP005 (ingenol mebutate) gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on head treatment areas, which include the face and scalp. These Phase 3 trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. They are designed to replicate the positive results demonstrated in earlier trials, specifically the results of the Phase 2b trial (PEP005-015) announced earlier this year. These trials are both randomized, double-blind, vehicle-controlled studies that are being conducted at multiple sites in the US and Australia. The primary efficacy endpoint for the REGION-II trials is the complete clearance rate of AK lesions and the secondary efficacy endpoint is the partial clearance rate of AK lesions within the treatment area. Peplin is also measuring the overall mean and median reduction in AK lesion count. Peplin plans to announce these trial results in fourth quarter of this year.  

PEP005 is a novel compound derived from the sap of Euphorbia peplus, or E. peplus, a rapidly growing, readily available plant with a long history of traditional use for a variety of conditions, including the topical self-treatment of various skin disorders, including skin cancer and pre-cancerous skin lesions.

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