Peplin's phase IIa 'sun spot' trial positive, second BCC trial enrolment complete

Peplin (ASX:PEP) has reported preliminary results of its US-based phase IIa dose escalation clinical trial to establish the maximum tolerated dose of PEP005 in actinic keratosis (AK), also known as solar keratosis, a skin condition which can develop into skin cancer.

The clinical trial has concluded that PEP005 Topical at 0.05 per cent concentration is well tolerated when applied once daily on two consecutive days to an area of skin with AK. In addition, blood samples confirmed no absorption of PEP005 into the blood stream. This concentration is equal to the highest concentration tested in Peplin's earlier phase IIa study in Australia and reported in November 2005 where two applications of the drug directly to lesions proved effective in clearing lesions.

"These are very important results and it is fantastic for people with actinic keratosis," said Peplin managing director and CEO Michael Aldridge. "In the first trial we applied the drug directly on the lesion. In this trial we rub the gel onto a much larger area of skin with actinic keratosis. It opens up the potential for this to be a prescription take home medication and that is a fundamentally larger market.

"There was also no absorption into the blood stream and that provides you with a lot of confidence you have a safe drug. We plan 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.

BCC cancer trials

Meanwhile Peplin has completed patient enrolment for its second Australian phase IIa clinical trial of PEP005 for basal cell carcinoma (BCC), the most common form of skin cancer.

"Getting the final patient for our nodular basal cell carcinoma (nBCC) study sets the timetable for our trial and we expect to announce the results in the third quarter of 2006," said Aldridge.

This clinical trial is being conducted by dermatologists in major metropolitan centres around Australia and will study two applications of PEP005 onto a nBBC tumour.

Peplin also expects to report the results of its first BCC phase IIa study, of patients with superficial basal cell carcinoma (sBCC), in the week commencing 1 May 2006.

"The last patient was treated in December 2005. They are being followed for three months -- we will analyse the data and then report the results," said Aldridge. "It is a very busy time for the company with results of three well controlled clinical trials to be announced in three quarters. It is the payback for investment last year. We have $18 million in the bank and are in a strong position to fund the ongoing development of the drug. We plan to take PEP005 for BCC into a more advanced clinical trail program which should commence later in 2006."

Peplin raised AUD$10 million through a placement in December 2005 to initiate and complete phase IIb clinical trials of PEP005 for actinic keratosis.

At press time Peplin shares were trading at $0.70 up 2 cents.