Ingenol mebutate (PEP005) gel to treat actinic keratosis leading to skin cancer is nearing approval: Leo Pharma

Ingenol mebutate (PEP005), an experimental gel treatment for pre-cancerous skin lesions actinic (solar) keratosis by Leo Pharma, has been shown effective in late-phase clinical studies.

Leopharma announced positive results for two Phase III actinic (solar) keratosis (AK) clinical trials using ingenol mebutate (PEP005) gel for the treatment of lesions on head treatment areas, which include the face and scalp.

The trials were initiated and run by US and Australia-based Peplin, Inc., acquired by LEO Pharma in the fall of 2009.

Two Phase III trials each achieved their primary and secondary efficacy endpoints with statistically significant clearance of AK lesions vs. vehicle.

The two completed Phase III clinical trials, known as REGION-IIa and REGION-IIb, enrolled approximately 250 patients each and evaluated the use of a 0.015% concentration of ingenol mebutate (PEP005) gel applied daily for three consecutive days to AK lesions on the face and scalp.

“The Peplin team has done an excellent job of executing the development program and completing the Phase III trials within the expected timeframe,” stated Lars Olsen, LEO Pharma’s Executive Vice President for Research & Development.

LEO Pharma has one additional Phase III clinical trial currently ongoing with PEP005 Gel for AK lesions. This Phase III trial, known as REGION-Ib, is for lesions on non-head locations, which includes the trunk and extremities, and was designed to replicate the previously completed, successful REGION-I trial and confirm its results.

REGION-Ib has completed enrolment of approximately 250 patients earlier this year and data is expected towards the end of Q1 2010.

Results from REGION I and Ib will be presented at an upcoming meeting of the American Academy of Dermatology.
Actinic keratosis is a common pre-cancerous skin condition caused by sun exposure, which can develop into skin cancers if left untreated.

The trials confirm the results of prior trials and we are closer to being able to provide the patients a 3-day course of therapy than ever, said Lars Olsen.

Cryotherapy, a procedure in which the surface skin lesions are frozen, is currently the most common treatment alternative for actinic keratosis. It is used as the sole approach in approximately 75 per cent of treatments for actinic keratosis lesions, and in combination with topical drugs in approximately 9 per cent of treatments.

The American Academy of Dermatology reports that 40 per cent of cases of squamous cell carcinoma begin as actinic keratosis.

LEO Pharma expects to market ingenol mebutate (PEP005) for actinic (solar) keratosis in 2012.

Founded more than 100 years ago, LEO Pharma is an independent, research-based specialty pharmaceutical company committed to the discovery and development of novel drugs for patients within the areas of Dermatology and Critical Care Medicine.