Peplin Completes Enrolment In Its Phase 3 Clinical Trials For PEP005 Gel In AK On The Face And Scalp

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Jul 2009 - 7:00 PDT

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Peplin, Inc. (ASX:PLI) announced the completion of enrolment of its two Phase 3 clinical 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 clinical 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. Peplin plans to announce the REGION-II trial results in the fourth quarter of this year.

Peplin's Chief Executive Officer, Tom Wiggans said: "The continued enthusiasm for our trials, as demonstrated by the remarkable speed of enrolment, highlights the unsatisfied medical need which PEP005 Gel addresses. The REGION-II trials are especially important as they are treating AKs on the face and scalp, which comprise an estimated 70% of the AK market and have the potential to provide the most patient benefit."

"Based on the data we have generated up to this point, we believe PEP005 Gel and its short course of therapy represent an advance in the treatment of a common skin condition, which, if left untreated, can progress to squamous cell carcinoma."

The REGION-II trials are both randomised, double-blind, vehicle-controlled studies that are being conducted at multiple sites in the US and Australia. Patients self apply the study medication (0.015%) or vehicle gel for three consecutive days to a 25-cm2 treatment area containing four to eight AK lesions on the face or scalp. 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.

In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities, and plans to initiate the REGION-Ib trial during the third quarter of 2009 to corroborate the results of the previously completed trial. Peplin plans to file a New Drug Application in mid-2010.

About PEPLIN

Peplin is a development stage specialty pharmaceutical company focused on advancing and commercialising innovative medical dermatology products. Peplin is currently developing ingenol mebutate, or PEP005, which is a novel compound derived from the sap of Euphorbia peplus, or E. peplus, a rapidly growing, readily available plant commonly referred to as petty spurge or radium weed. E. peplus has 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. Peplin's lead product candidate is a patient-applied topical gel containing ingenol mebutate, a compound the use of which Peplin has patented for the treatment of actinic (solar) keratosis, or AK. This product candidate referred to as PEP005 (ingenol mebutate) Gel is currently in Phase 3 clinical trials, having just completed their first Phase 3, known as REGION-Ia.

About AK

Actinic keratoses (AK), also known as solar keratosis or sun spots, is generally considered the most common pre-cancerous skin condition. AK usually appears as small, rough, scaly areas on the face, lips, ears, back of hands, forearms, scalp or neck. If left untreated, AK lesions may progress to a form of skin cancer called squamous cell carcinoma, or SCC. The Lewin Group, Inc., estimates that the total direct costs for AK in the United States was $1.2 billion in 2004, and in 2002 there were approximately 8.2 million office visits for the treatment of AK. The Lewin Group also estimated that there were 58 million people in the United States living with AK in 2004. According to a May 2006 issue of The Journal of Family Practice, in northern hemisphere populations, 11% to 25% of adults have at least one AK lesion, compared with 40% to 60% of adults in Australia, which has the highest prevalence of AK worldwide.

Source
Peplin, Inc.