Clinuvel Pharmaceuticals is currently working on a rice-grain sized implant that when placed under the skin induces a tan and provides increased UV protection.
The dermatology-focused biotech, formerly known as Epitan, had initially marketed its leading drug as a tanning product, saying it produces eumelanin, a pigment which can protect skin from UV exposure.
But under its new name Clinuvel, the company said the same drug, CUV1647, is also a serious clinical treatment for a range of skin conditions.
Clinuvel said those conditions include polymorphous light eruption (PLE) or sun poisoning and actinic keratosis (AK), a skin cancer precursor.
Dr Wolgen [CEO Pilippe Wolgen-ed.] said interim results from phase II clinical trials showed the efficacy of the implant as a treatment for patients suffering from moderate to severe PLE.
“The interim results of this study, conducted at St Vincent’s Hospital in Melbourne, place the company firmly on track to prepare phase III trials with CUV1647 in PLE in the southern hemisphere in the later half of 2006,” he said.
“The current clinical program will be followed by additional trials in Australia, Europe and USA aimed at receiving approval in all major markets.
“Together with actinic keratosis we seem to have found a solid development and registration program for CUV1647.”
Phase III trials of the drug are scheduled to begin in Australia later this year followed by the US and Europe in 2007.