EpiTan basks in glow of positive human trial results

An Australian-made tanning drug has shown positive results in its first human trials.

Melbourne company EpiTan (ASX: EPT) today announced its Melanotan had proved safe in healthy volunteers and had produced a modest glow in their skin, despite participants being instructed to stay out of the sun and wear SPF 30+ sunscreen.

Managing director Dr Wayne Millen said the next round of tests would permit participants to have "normal daily activity" sun exposure, with a deeper tan the expected result.

He said the company also planned to use the next study phase, titled the "sunburn" clinical trial, to examine the possible protective role of the increased pigmentation against the damaging effects of UV radiation.

"To have achieved the results we did in this Phase I/II trial is a significant step on the path to the commercialisation of Melanotan," said Millen.

"Completing the trial successfully is a critical milestone for us, with the trials confirming our strategic direction to focus on a drug delivery formulation to minimise side effects and enhance delivery while maintaining efficacy."

Melanotan works by stimulating the production of melanin in the skin, as happens when skin is exposed to sunlight.

Millen believes that the 13 amino acid peptide, which is administered subcutaneously, could produce a normal tan while at the same time reducing the incidence of skin cancer.

Two in every three Australians develop skin cancer, with one in 16 diagnosed with melanoma.

Skin cancer treatments are estimated to cost Australia more than $500 million annually, making it the most expensive of any cancer.

The Phase I/II safety trial was conducted as a randomised, placebo-controlled, double blind study at the Royal Adelaide Hospital and involved 16 volunteers.

Of this group, 12 received Melanotan and four were given placebos.

The preliminary study report, released today, showed no difference between plasma concentration versus time profiles between the first and final doses, suggesting no accumulation of the drug and no change in pharmacokinetics after multiple dosing.

The drug was also found to have a rapid absorption and short half-life.

Nonetheless, some participants did experience side-effects including nausea, injection site problems and facial flushing.

The company said it planned to reformulate the drug into a sustained release form to minimise such effects.

Spectrophotometric measurements taken during the trial confirmed Melanotan caused a statistically significant elevation in calculated melanin density in the skin of the volunteers receiving drug, but not in those receiving placebos.

Independent research group CMAX conducted the clinical trial during November and December last year.