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Positive Results for Peplin's Phase IIb AK Trial
08 / 01 / 2009
Met primary efficacy endpoint with statistically significant complete clearance rate of AK lesions vs. vehicle
Reduction in overall lesion count in all active treatment groups
Well-tolerated, rapidly resolving local skin responses at all concentrations and durations
Clear dose response effect
Peplin, Inc. (ASX:PLI) today announced positive results with its lead product candidate PEP005 (ingenol mebutate) Gel in its Phase IIb actinic (solar) keratosis (AK) dose ranging clinical trial (PEP005-015) for the treatment of AK lesions on head locations, which comprise the face and scalp. AK is a common pre-cancerous skin condition caused by sun exposure. The face is the most common area for sun damage and the most common area for AK's, which can develop into skin cancers if left untreated.
As in previous trials, this study demonstrated a clear dose response relationship with four out of the six treatment groups achieving statistically significant clearance of AK lesions when compared with vehicle. The complete clearance rates ranged from 15.6% to 42.3% across the six active treatment groups. At all concentrations, for both the two day and three day treatments, the PEP005 Gel demonstrated a favourable safety profile and was well tolerated; side effects comprised primarily of transient, short term, local skin responses at the treatment site which peaked at Day 4 and returned to baseline by Day 15. There were no drug-related serious adverse events reported.
In the highest treatment group (0.015% PEP005 Gel for three consecutive days) the complete clearance rate (primary efficacy endpoint) was 42.3% (p=0.005 compared to vehicle) and the median reduction in lesion count was 84.5%. Additional trial results will be presented in an appropriate upcoming medical forum.
PEP005-015 was an eight-arm, 240-patient, US and Australian multi-centre, randomised, double-blind, vehicle-controlled, dose-ranging clinical trial. It was designed to evaluate the safety and efficacy of each of three concentrations (0.005%, 0.010% or 0.015%) and two treatment regimens (once a day for two or three consecutive days) for Peplin's patented product, PEP005 Gel in patients with AK lesions on the head when used as field-directed therapy.
Sydney dermatologist and one of the Australian trial investigators, Dr. Robert Rosen, said current treatment options for AK have a number of shortfalls, including how they impact the skin during prolonged treatment periods.
"The major challenge we face is patient dissatisfaction with current topical medications, which have long durations of treatment, pain and persisting skin irritation and redness." Dr. Rosen said.
"As a result, patients are often unwilling to use their medications, particularly for lesions on the face and scalp. Therefore, a topical medication which can effectively and conveniently treat AK lesions in two or three days will be of significant benefit to doctors and their patients."
Peplin's Chief Executive Officer, Tom Wiggans, is extremely pleased with the positive results from Peplin's lead product development program.
"The completion of our Phase II program represents a significant milestone for Peplin and takes us an important step closer to commercialisation.
The data are consistent with prior trials and will allow us to select both a dose and regimen for our Phase III development which would make PEP005 Gel, if approved, a very important new product for the treatment of AK. As no current product on the market has a short course of therapy and proven efficacy for both head and non-head lesions, the potential value that PEP005 Gel offers patients is considerable."
Peplin's Chief Scientific Officer, Peter Welburn, also expressed his delight at the successful results which were reported within the anticipated timeframe.
"Managing the development of this product through Phase I and II trials, with the results consistently demonstrating statistically significant clearance of AK lesions at varying dosage regimens, has been very rewarding. The rapi
Reduction in overall lesion count in all active treatment groups
Well-tolerated, rapidly resolving local skin responses at all concentrations and durations
Clear dose response effect
Peplin, Inc. (ASX:PLI) today announced positive results with its lead product candidate PEP005 (ingenol mebutate) Gel in its Phase IIb actinic (solar) keratosis (AK) dose ranging clinical trial (PEP005-015) for the treatment of AK lesions on head locations, which comprise the face and scalp. AK is a common pre-cancerous skin condition caused by sun exposure. The face is the most common area for sun damage and the most common area for AK's, which can develop into skin cancers if left untreated.
As in previous trials, this study demonstrated a clear dose response relationship with four out of the six treatment groups achieving statistically significant clearance of AK lesions when compared with vehicle. The complete clearance rates ranged from 15.6% to 42.3% across the six active treatment groups. At all concentrations, for both the two day and three day treatments, the PEP005 Gel demonstrated a favourable safety profile and was well tolerated; side effects comprised primarily of transient, short term, local skin responses at the treatment site which peaked at Day 4 and returned to baseline by Day 15. There were no drug-related serious adverse events reported.
In the highest treatment group (0.015% PEP005 Gel for three consecutive days) the complete clearance rate (primary efficacy endpoint) was 42.3% (p=0.005 compared to vehicle) and the median reduction in lesion count was 84.5%. Additional trial results will be presented in an appropriate upcoming medical forum.
PEP005-015 was an eight-arm, 240-patient, US and Australian multi-centre, randomised, double-blind, vehicle-controlled, dose-ranging clinical trial. It was designed to evaluate the safety and efficacy of each of three concentrations (0.005%, 0.010% or 0.015%) and two treatment regimens (once a day for two or three consecutive days) for Peplin's patented product, PEP005 Gel in patients with AK lesions on the head when used as field-directed therapy.
Sydney dermatologist and one of the Australian trial investigators, Dr. Robert Rosen, said current treatment options for AK have a number of shortfalls, including how they impact the skin during prolonged treatment periods.
"The major challenge we face is patient dissatisfaction with current topical medications, which have long durations of treatment, pain and persisting skin irritation and redness." Dr. Rosen said.
"As a result, patients are often unwilling to use their medications, particularly for lesions on the face and scalp. Therefore, a topical medication which can effectively and conveniently treat AK lesions in two or three days will be of significant benefit to doctors and their patients."
Peplin's Chief Executive Officer, Tom Wiggans, is extremely pleased with the positive results from Peplin's lead product development program.
"The completion of our Phase II program represents a significant milestone for Peplin and takes us an important step closer to commercialisation.
The data are consistent with prior trials and will allow us to select both a dose and regimen for our Phase III development which would make PEP005 Gel, if approved, a very important new product for the treatment of AK. As no current product on the market has a short course of therapy and proven efficacy for both head and non-head lesions, the potential value that PEP005 Gel offers patients is considerable."
Peplin's Chief Scientific Officer, Peter Welburn, also expressed his delight at the successful results which were reported within the anticipated timeframe.
"Managing the development of this product through Phase I and II trials, with the results consistently demonstrating statistically significant clearance of AK lesions at varying dosage regimens, has been very rewarding. The rapi