Peplin Limited today announced positive results from its Australian phase IIa clinical trial of its proprietary drug PEP005 Topical in superficial forms of basal cell carcinoma (sBCC) the most common form of skin cancer.
The phase IIa clinical trial achieved its objectives. Just two applications of PEP005 Topical (0.05%) gel on two consecutive days cleared 71% of sBCC tumours. This result was statistically significant (p=0.02). In addition PEP005 Topical gel had a favourable safety profile and was well tolerated. The majority of local skin responses reported were graded mild or moderate.
Managing Director & CEO Michael Aldridge said these positive results were a significant milestone for the company and of great interest to people with skin cancers in Australia and worldwide.
“The results of this Australian clinical trial exceeded our expectations,” Mr Aldridge said.
“While we achieved the primary purpose of the trial which was to establish the safety of the drug in treating non-melanoma skin cancers, we have shown that two consecutive days of treatment with PEP005 Topical gel can clear nearly three quarters of basal cell carcinomas, the most common form of skin cancer.
“Our next steps will be to undertake larger trials in Australia and the US starting later this year in order to make application to obtain regulatory approval to market the product as quickly as possible.”
Revision date: June 18, 2011
Last revised: by Jorge P. Ribeiro, MD