News & Events

SKIN treatment specialist Peplin has reported "positive" results from a late-stage clinical trial of its gel to treat pre-cancerous sun spots.

It says it is on track to have the product on the' market by early 2011.

Brisbane-based Peplin yesterday released the results of a phase III trial in the use of its weed-derived gel, PEP005, to treat actinic keratosis lesions on arms, body and legs.

In the trial, the gel met the primary and secondary endpoints that measured its efficacy following a two-day course of treatment. Among the 255 patients from Australia and the US, the median reduction in the number of lesions was 66.7 per cent, with 27.4 per cent of patients having all of their lesions successfully treated.

"These strong results achieve an important step towards commercialisation," said chief executive Tom Wiggans. The company also intends to launch by the end of next month a phase III trial to test the gel on lesions on the head and face.

That trial is expected to be completed by the end of the year, allowing the company to lodge its application for marketing approval with the US Food and Drug Administration by the middle of next year. If the company meets its timetable, the product will be able to be sold in the US by early 2011.

While the company has not ruled out licensing the product, Australian general manager Peter Welburn said the preference was for the company to keep control of the product.

Last Friday, the dual Australia-US listed company reported it had a cash balance at the end of March of $US26.1 million ($A34.7 million). Mr Welburn said that was enough for it to complete the clinical trial program.