Sunburn Trial Results Show Drug Can Reduce Sun Damage by 50% for Fair-Skinned People, says Trial Head

Fair-skinned people – who traditionally burn the most in the sun – benefited most from an anti-sunburn drug which has finished Phase II human trials, the Professor of Dermatology at Sydney University said today.

Professor Ross Barnetson – a world authority in the field of photobiology, ultraviolet skin damage and the immunology of skin tumours – ran the Phase II human trials at Sydney University, alongside a concurrent trial at Royal Adelaide Hospital. Eighty volunteers took part in the trial.

Results of the trial into the drug Melanotan – which stimulates the production of melanin in the skin – showed that:

• There was a highly-significant increase in skin melanin in Melanotan-treated volunteers
• Fairer-skin people (Types I/II) recorded increases in melanin of up to 100% in some areas
• Sunburn injury was reduced by more than 50% in the fair- skinned volunteers
• People vastly underestimated their natural skin-protection levels. Only 7% of volunteers thought they had Fitzpatrick Skin Type I (always burns/ never tans). The real number was 36%

“The aim of the trial was to determine how Melanotan could reduce the degree and toxicity of sunburn in 80 healthy volunteers exposed to ultraviolet light both before and after a regime of the drug,” said Professor Barnetson. “The fair-skinned people who took Melanotan had half the skin damage after the study compared to before the study. The results showed that fair-skinned people who have developed a tan are less likely to burn.”

The drug was administered daily for ten days in each of three consecutive months. Twenty volunteers received placebos. The volunteers, of varying skin types, received controlled levels of UVA and UVB radiation onto a small area of skin resulting in a level of burning similar to spending 30-120 minutes in strong sun without sunscreen. A skin biopsy was taken from each to measure the level of resulting sunburn injury. The volunteers then received a regime of Melanotan, the same UV radiation exposure, and another skin biopsy.

A volunteer in the trial, Rachel Preece, a 25-year-old medical student, said that the drug gave her an even, all-over tan. She said she recognised the protective elements of the tan. “I am not a sun-lover and don’t go on the beach often. Being a medical student I see a lot of bad effects of sun-baking with skin cancers. I would take this drug if it was commercialised.”

Professor Alan Cooper, Head of the Department of Dermatology at Sydney’s Royal North Shore Hospital, said: “I think its reasonable that we can consider Melanotan to be an internal sunscreen. Melanin is the body’s natural sunscreen and this is a way of increasing the amount of melanin we have.”

Dr Wayne Millen, Managing Director of EpiTan – the biotechnology company developing Melanotan – said he was delighted with the results. “The results improve our chances of commercialising the world’s first prescription sunscreen. There is no other product available today to prevent sunburn apart from sunscreen. We expect Melanotan to be especially beneficial to those people with fair skin types who are most at risk of sunburn injury and therefore of developing skin cancers.”

EpiTan recently announced that, following a successful meeting with the United States Food & Drug Administration, it would lodge an Investigational New Drug application in mid-2004. Clinical trials for a newly-developed long-acting implant has begun at Q-Pharm in Queensland. This trial is expected to conclude in May 2004.

For more information contact:

Professor Ross Barnetson, Sydney University, 02 9515-6861
Mr Iain Kirkwood, Chief Administrative Officer, EpiTan Limited, Tel: 03 9662-4688 or 0408 473 496
Mr Richard Allen, Monsoon Communications, Tel: 03 9620-3333 or 0403 493 049