Clinuvel gets early nod on sun drug

Melbourne biotech Clinuvel Pharmaceuticals will begin a Phase III trial of its photo-protective drug CUV1647 earlier than expected after positive results from a Phase II trial being conducted in Switzerland.

The Phase III trial, at the Triemli Hospital in Zurich, is aimed at determining whether CUV1647, an analogue of alpha-melanocyte stimulating hormone, can reduce the number and severity of phototoxic reactions in patients with erythropoietic protoporphyria (EPP, or absolute sun intolerance).

It will also determine whether CUV1647 can increase the duration of exposure to sunlight that can be tolerated by EPP patients, Clinuvel's CEO, Dr Philippe Wolgen, said.

"Applications to obtain ethics and regulatory approval are currently being prepared and submitted in a number of other trial sites across Europe and Australia," Wolgen said.

"Additionally, the first Australian Phase III EPP trial is scheduled to start in the second half of 2007."

Wolgen said it was anticipated that between 50 and 70 EPP patients will participate in the trial with patients undergoing 12 months of treatment. Interim results are expected to be available in mid-2008.

If the study is successful, Clinuvel will seek regulatory approval to market CUV1647 for the prophylactic treatment of phototoxic reactions in EPP patients.

Clinuvel terminated its Phase II trial ahead of schedule after positive preliminary results in order to advance directly to an expanded multicentre Phase III trial, he said.

"Depending on the outcome of this trial, CUV1647 may provide EPP patients with a preventative treatment that enables them to be more resistant to the effects of UV and light."