Positive results for Peplin phase IIa 'sun spot' trial
Monday, 28 November, 2005
Peplin (ASX:PEP) has reported positive results from its phase IIa clinical trial of its proprietary drug PEP005 Topical in actinic keratosis (AK), also known as solar keratosis, a skin condition which can develop into skin cancer.
The primary purpose of the trial was to evaluate the safety of the drug. The majority of local skin reactions were mild or moderate. Application of PEP005 Topical (0.05 per cent) gel for two days completely cleared 71 per cent of lesions.
"These results exceeded our expectations," said Peplin managing director and CEO Michael Aldridge. "We have a higher prevalence of solar keratosis in Australia than anywhere in the world and dermatologists have been looking for a safe and effective way to manage this disease."
Dermatologist and principal investigator Dr Greg Siller said the study had shown the drug to be well tolerated with a favourable safety profile.
"The drug appears to be active following just two treatment applications, which is quite unique," he said in a statement. "If these results are validated in larger trials this product would be a great advance for our patients in the treatment of solar keratosis."
The phase IIa clinical trial, which was initiated in March, was a double-blind, vehicle controlled, randomised, parallel group study of 58 subjects at six centres across Australia. PEP005 Topical in one of three concentrations or vehicle gel was applied to AK lesions on two days and subjects were followed for 12 weeks.
"Peplin plans to conduct larger trials of PEP005 Topical in AK in Australia and the US starting in 2006 with the aim of progressing the product to market as quickly as possible," said Aldridge.
AK is a common skin condition characterized by rough, red, scaly patches, crusts or sores on the top layer of the skin. If left untreated AKs can progress to squamous cell carcinoma, an invasive skin cancer that can be fatal. Current treatment alternatives comprise surgical techniques (primarily cryotherapy) and topical medications. Peplin believes the short treatment period for AK will be an important differentiating factor for the product.
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