Clinuvel moves to phase III for PLE

Melbourne biotech Clinuvel Pharmaceuticals has received the go-ahead to commence phase III trials in the UK of its photo-protective drug, CUV1647, in patients with polymorphous light eruption (PLE).

PLE is more commonly known as sun-poisoning and results in blisters, vesicles and patches on the skin after exposure to UV radiation. It has a severe effect on the quality of life of sufferers as they are unable to go outside during spring and summer.

CUV1647 acts by increasing levels of eumelanin in the skin and appears to protect against prolonged UV radiation. Increased pigmentation in the skin appears after a few days and may last up to several months. The drug is delivered from a subcutaneous implant.

Clinuvel is also targeting other photo-sensitive disorders such as erythropoietic protoporphyria (EPP), a rare inherited porphyrin metabolism disorder that results in excruciating pain when the skin is exposed to the sun; solar urticaria, which results in itchiness and burning redness on exposed skin; and actinic keratosis, which are pre-cancerous skin growths.

Last year, the company applied for a patent for CUV1647 for the prevention of skin cancer in organ transplant patients.

The multi-centre, double-blind, placebo controlled trials in the UK aim to confirm whether CUV1647 prevents or reduces the severity of PLE symptoms. Up to 200 patients will be enrolled in the trials, which are scheduled to take place throughout the 2007 and 2008 spring and summer seasons.

The company said preliminary data on the first season will be available in late 2007 or early 2008. It has also applied to begin phase III trials across Europe.

See the March/April 2007 edition of Australian Life Scientist, due out on March 30, for more on Clinuvel.