Peplin gears up for skin drug trials

Brisbane's Peplin Biotech (ASX:PEP) has enrolled the last of 60 Australian patients for its Phase IIa clinical trial of its topical PEP005 treatment for actinic keratoses (AKs) -- pre-cancerous, dry, scaly areas of sun-damaged skin.

Peplin has also announced plans for a dose-ranging trial in the US, to assess PEP005's potential as a topical treatment for large, contiguous AK lesions that are not amenable to the current preferred method of freezing skin lesions with liquid nitrogen.

The company's announcement coincided with a missive from the ASX, querying an overnight 4c slide in the company's share price.

Peplin replied that it was unaware of any reason for the dip, and said it does not expect its 2004-05 pre-tax operating loss to exceed last February's forecast AUD$5.1 million by more than 15 percent.

Last November the company projected net outlays of $12.1 million to complete its three current phase IIa clinical trials of PEP005 by the end of this year -- one for actinic keratoses, and two others for basal cell carcinoma (BCC).

The 60 volunteers in its AK trial have been enrolled at in clinical cities in major metropolitan cities around Australia. Each has at least five discrete AK lesions, which will be treated by rubbing in gel-based PEP005.

Peplin CEO Dr Michael Aldridge said the double-blind, placebo controlled trial will assess three different-strength formulations, and two regimes: consecutive applications on the first two days of the three-month trial, and spaced applications on days 1 and 8. The latter period reflects the typical interval between a patient's consultations with their dermatologist.

Aldridge said the US trial will test PEP005 as a rapid, cosmetically attractive treatment for large areas of skin with multiple AK lesions.

The two BCC trials involve topical application of PEP005 to nodular lesions, and superficial lesions. Aldridge said enrolments are well advanced, but are taking longer because BCC is a less common form of skin cancer.