Peplin, Inc announced the initiation of its second non-head phase-3 clinical trial to confirm the efficacy and safety of PEP005 (ingenol mebutate) gel for the treatment of actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, when applied to non-head locations, which include the trunk and extremities. This second pivotal phase-3 trial for non-head locations, known as REGION-Ib, is designed to replicate the recently completed REGION-I trial and confirm the results of PEP005 gel, which showed a total clearance rate across all anatomical non-head locations of 27.4 per cent (p<0.0001), a median lesion reduction of 66.7 per cent (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.
chief executive officer Tom Wiggans said, "Achieving this additional milestone immediately following the rapid enrolment in our phase-3 head trials, demonstrates our commitment to progressing PEP005 gel through the final phase of our clinical development process. Based on the data we generated in the REGION-I trial, we believe PEP005 gel with its short course of therapy represents a significant 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 will be conducted at multiple sites in the US. Peplin expects to enrol approximately 200 patients who will self-apply the study medication (0.05 per cent) or vehicle gel for two consecutive days to a 25 cm2 treatment area containing four to eight AK lesions. As with prior trials, the primary efficacy endpoint for the REGION-Ib 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 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 head locations, which include the face and scalp, and announced the results from its REGION-I trial, the first phase-3 for non-head locations, earlier this year. Peplin will complete their phase-3 clinical trials for AK by the end of this year and plans to file a New Drug Application in mid-2010.
Peplin is a development stage specialty pharmaceutical company focused on advancing and commercialising innovative medical dermatology products.