EpiTan boosted by drug delivery trial results

By Melissa Trudinger
Wednesday, 11 February, 2004

Tanning drug developer EpiTan (ASX:EPT) has announced better than expected efficacy in its Phase II trial to evaluate the delivery of its Melanotan drug via an implant.

The company reported today that the first six patients in the trial, which started in November at contract researcher Q-Pharm's Queensland facility, demonstrated a rapid and substantial increase in melanin levels after receiving the implant, despite being the two lowest doses planned for the trial. The effects of the drug, which causes a natural tanning response, have so far persisted for 60 days.

Now the company is re-engineering its implant to contain significantly less drug in a smaller implant unit, so that it can continue its dose escalation study from a lower base.

According to the company's chief administrative officer Iain Kirkwood, the original implant dose was extrapolated from the amount of drug required in earlier injection trials.

"With an aqueous injection you get a bolus effect, and the body can't cope with the volume of drug injected, so it wastes it," he said. "But the implant form is very efficient. The long and short of it is that the implant works."

The trials are now expected to take until the third quarter of this year to complete, but Kirkwood said plans to file an investigational new drug (IND) application with the US Food and Drug Administration mid-year were still on track.

The market responded favourably to the news, sending EpiTan's shares as high as AUD$0.79 on heavy volumes. At the time of writing, the share price was up 7.25 per cent at $0.74.

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