Peplin completes four-week enrolment phase for REGION-Ib trial

Aug 20 2009

Peplin, Inc. (ASX:PLI) today announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.

This second pivotal Phase 3 trial for non-head locations, known as REGION-Ib, enrolled approximately 200 patients. It is designed to replicate the recently completed REGION-I trial and confirm the results of that trial in which PEP005 Gel, 0.05%, demonstrated a total clearance rate across all anatomical non-head locations of 27.4% (p<0.0001), a median lesion reduction of 66.7% (p<0.0001) and statistical significance when compared to vehicle for clearance of AK’s on the chest and the especially difficult-to-treat locations, the arm and back of hand. Peplin plans to complete the REGION-Ib trial results in the fourth quarter of this year.

Peplin’s Chief Executive Officer, Tom Wiggans said: “A four week enrolment period for our REGION-Ib trial further demonstrates the enthusiasm by physicians and their patients for new AK treatment options, validating the existence of an unsatisfied medical need that PEP005 Gel could fulfill.

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

REGION-Ib is a randomised, double-blind, vehicle-controlled clinical trial that is being conducted at multiple sites in the US. Patients self-apply the study medication (PEP005 Gel, 0.05%) or vehicle gel for two consecutive days to a 25-cm² treatment area containing four to eight AK lesions. As with previous trials, the primary efficacy endpoint for this pivotal trial will be the complete clearance rate of AK lesions, and the secondary efficacy endpoint will be the partial clearance rate of AK lesions within the treatment area. Peplin will also measure the overall median percent reduction of AK lesions.

In addition to the REGION-Ib trial on non-head locations, Peplin recently completed enrolment in its REGION-IIa and REGION-IIb trials for the treatment of AKs on the face and scalp (head locations). Earlier this year, Peplin also announced the results from its REGION-I trial, the first Phase 3 trial for non-head locations. Peplin will complete its Phase 3 clinical trials for AK by the end of this year and plans to file a New Drug Application in mid-2010 for the treatment of AK lesions on both head and non-head locations.