Peplin cancer drug in US dose-escalation trial

Brisbane oncology-drug developer Peplin (ASX:PEP) has begun a phase IIa dose-escalation trial of its PEP005 lead product for pre-cancerous skin lesions, or actinic keratoses (AKs) caused by ultraviolet radiation in sunlight.

Peplin is already running a phase II trial its AK therapy on discrete skin lesions in Australian volunteers. The US trial will evaluate PEP005's ability treat larger areas of skin with multiple or contiguous AK lesions.

Peplin MD and CEO Michael Aldridge said the company believes there is a significant market opportunity for a rapid-acting, cosmetically attractive non-surgical treatment that can be used on both discrete lesions and larger areas of AK-damaged skin.

Dermatologists currently treat discrete AK lesions with cryotherapy or other ablation techniques, that Aldridge said can be painful and sometimes produce cosmetically unattractive results. Multi-week courses of pharmaceuticals, such as skin creams, are usually prescribed for larger or contiguous lesions.

Peplin's initial, phase I US trial in 16 patients demonstrated the drug's favourable safety profile, and the ability of a one-off application to significantly improve patients' AK lesions within 21 days.

The new, phase IIa dose-escalation trial will recruit between 13 and 34 patients to determine the maximum tolerated dose of PEP005 topical gel, administered daily on two consecutive days. The effects will be monitored over the next four weeks.

Once the dose-escalation study has defined a maximum tolerated dose (MTD), a total of 10 volunteers will be treated at this dose to determine its efficacy in clearing AK lesions, measure any systemic absorption of the drug, and establish a safety profile at the highest dose.