Clinuvel begins controlled-release implant trial
Wednesday, 01 March, 2006
Melbourne's Clinuvel Pharmaceuticals (ASX:CUV), formerly Epitan, has begun a trial in Adelaide of its lead drug CUV1647 in a controlled-release pellet form.
The pharmacokinetic study will test the tolerability and efficacy of the 12 mg sustained release pellet of CUV1647 which will be placed under the skin of six healthy male patients. The pellet, developed over the past two years, is expected to be the final commercial formulation of CUV1647 and will be used in remaining phase II and III trials of the drug.
"The trial should be finished within 60 days, with a follow up for another 30 days, and by May or June we should know the first results," said Clinuvel CEO Philippe Wolgen.
The redefined clinical trial program of CUV1647, formerly known as Melanotan, focuses on UV related skin diseases with indications for polymorphous light eruption (PLE) and actinic keratosis (AK).
Assoc Prof Robert Milne from the University of South Australia will lead the trial which will be the first clinical use of a formulation of CUV1647 derived from the company's dose escalation study results.
Meanwhile, Clinuvel's name change is complete with the company's ASX ticker today converting from EPT to CUV. "A small, trivial change but it attracts enormous interest," said Wolgen.
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