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Peplin Completes Enrolment for its First Phase III AK Clinical Trial
16 / 12 / 2008
Peplin, Inc. (ASX:PLI) today announced the completion of enrolment of its 250 patient pivotal Phase III US and Australian clinical trial in actinic (solar) keratosis (AK), a common pre-cancerous skin condition affecting between 40 and 60 percent of adult Australians and accounting for at least 5.8 million annual visits to the dermatologist in the U.S.
This Phase III trial (also known as REGION-I) aims to replicate the safety and efficacy demonstrated in earlier studies of Peplin's proprietary product, PEP005 (ingenol mebutate) Gel, for AK lesions on non-head treatment areas, which include the trunk and extremities. Peplin expects to announce the results of its REGION-I trial in the first half of 2009.
Peplin's Chief Executive Officer, Tom Wiggans, is extremely pleased with the progress of Peplin's lead product development program.
"The completion of enrolment for our first Phase III trial represents a significant milestone in what has been an exciting phase for Peplin. The enthusiasm for the trial and the speed of enrolment emphasizes the unsatisfied medical need which our product addresses. Based on the data we have generated to this point in earlier studies, we believe PEP005 Gel and its short course of therapy represents a significant advance in the treatment of this common skin condition, which if left untreated can progress to non-melanoma skin cancer. With no other product like this currently on the market, the potential for patients, as well as investors, is considerable."
REGION-I is a multi-center, randomized, double-blind, parallel group, vehiclecontrolled clinical trial being conducted at Australian and US sites under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA). The SPA represents the FDA's agreement that the design, clinical endpoints and planned statistical analyses of the REGION-I protocol are adequate to form a basis for approval of a New Drug Application (NDA). The FDA's agreement on the SPA is binding, except in limited circumstances, such as the identification of a safety issue after the testing is initiated.
The primary efficacy endpoint for this clinical trial is the complete clearance rate of AK lesions within the assigned treatment area. The secondary efficacy endpoint will be the partial clearance rate of AK lesions within the treatment area. Peplin will evaluate efficacy on the 57th day after treatment.
REGION-I is the first of the planned Phase III trials for PEP005 Gel for AK. Pending supporting data from Peplin's recently enrolled PEP005-015, a dose-ranging Phase IIb clinical trial, which focuses on patients with AK lesions located on their head, and assuming a successful End-of-Phase II meeting with the FDA, Peplin plans to initiate a subsequent Phase III clinical trial for patients with AK lesions on the head in 2009.
This Phase III trial (also known as REGION-I) aims to replicate the safety and efficacy demonstrated in earlier studies of Peplin's proprietary product, PEP005 (ingenol mebutate) Gel, for AK lesions on non-head treatment areas, which include the trunk and extremities. Peplin expects to announce the results of its REGION-I trial in the first half of 2009.
Peplin's Chief Executive Officer, Tom Wiggans, is extremely pleased with the progress of Peplin's lead product development program.
"The completion of enrolment for our first Phase III trial represents a significant milestone in what has been an exciting phase for Peplin. The enthusiasm for the trial and the speed of enrolment emphasizes the unsatisfied medical need which our product addresses. Based on the data we have generated to this point in earlier studies, we believe PEP005 Gel and its short course of therapy represents a significant advance in the treatment of this common skin condition, which if left untreated can progress to non-melanoma skin cancer. With no other product like this currently on the market, the potential for patients, as well as investors, is considerable."
REGION-I is a multi-center, randomized, double-blind, parallel group, vehiclecontrolled clinical trial being conducted at Australian and US sites under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA). The SPA represents the FDA's agreement that the design, clinical endpoints and planned statistical analyses of the REGION-I protocol are adequate to form a basis for approval of a New Drug Application (NDA). The FDA's agreement on the SPA is binding, except in limited circumstances, such as the identification of a safety issue after the testing is initiated.
The primary efficacy endpoint for this clinical trial is the complete clearance rate of AK lesions within the assigned treatment area. The secondary efficacy endpoint will be the partial clearance rate of AK lesions within the treatment area. Peplin will evaluate efficacy on the 57th day after treatment.
REGION-I is the first of the planned Phase III trials for PEP005 Gel for AK. Pending supporting data from Peplin's recently enrolled PEP005-015, a dose-ranging Phase IIb clinical trial, which focuses on patients with AK lesions located on their head, and assuming a successful End-of-Phase II meeting with the FDA, Peplin plans to initiate a subsequent Phase III clinical trial for patients with AK lesions on the head in 2009.