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Peplin Initiates its Final Phase 3 Clinical Trial for PEP005 Gel in AK
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Peplin, Inc. has 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% (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.
REGION-Ib is a randomized, 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%) 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.
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% (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.
REGION-Ib is a randomized, 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%) 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.
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