Clinuvel Release: FDA Allows World First Vitiligo Drug Trial  
3/2/2011 2:53:28 PM

FDA Allows World First Vitiligo Drug Trial Thursday 3rd March 2011 Baar, Switzerland and Melbourne, Australia -- A new treatment for one of the world's most distressing skin disorders is about to commence trials across the USA and Europe. The USA's Food and Drug Administration (FDA) has agreed to allow a pilot trial of the new drug SCENESSE® (afamelanotide) to determine whether it can help repigment the skin of patients with vitiligo.

Vitiligo is an autoimmune disease which causes patchy loss of skin color in 'lesions' which spread over the body. Onset of the disease can be sudden and lesions can spread quickly. Vitiligo affects all races but is most visible in individuals with darker skin. Global studies have shown vitiligo can have a significant impact upon an individual's quality of life as their skin inexplicitly and dramatically changes color.

SCENESSE®, an injectable which mimics the body's natural ability to activate the skin pigment melanin, will be trialled in nonsegmental vitiligo; the most common form of the disease which affects over 45 million individuals globally.

The drug will be tested in combination with narrow-band ultraviolet B (NB-UVB) light therapy, a recognised treatment but one which takes up to 18 months of twice- or thrice-weekly clinical visits to return pigment to the skin. The goal of the trial is to determine whether SCENESSE® will reduce the dose of radiation (NB-UVB) and the time required to reactivate skin pigment producing cells in vitiliginous lesions.

Dr Pearl E Grimes, M.D., director of the Vitiligo and Pigmentation Institute of Southern California and a lead investigator on the study, is optimistic at the potential of a new treatment for vitiligo.

"Vitiligo is a complex disease and treatment response varies," Dr Grimes said. "The potential modality of this new treatment in combination with an existing therapy is promising and I look forward to our first clinical results."

The study's sponsor, biopharmaceutical company Clinuvel, is conducting the trial of up to 120 patients at six expert global vitiligo centres, three each in the USA (California, Michigan and New York) and Europe. Approval for the trial has been granted in Italy with applications pending in France and Switzerland.

Clinuvel's CEO, Dr Philippe Wolgen, said the company had received a surprisingly large number of enquiries in response to its trial program known as INSPIRE (International SCENESSE® Pilot Repigmentation Evaluation).

"Vitiligo has a significant impact upon people's lives and we have seen much anticipation from both patients and physicians at the potential for a new treatment," Dr Wolgen said.

SCENESSE® has been safely tested in over 550 patients in over a decade of clinical trials as a sun and light protective drug. Pending ongoing trials, the drug could be available in the Europe for the rare light intolerance erythropoietic protoporphyria (EPP) by 2012.

About Clinuvel Pharmaceuticals Limited

Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a leading and innovative Australian company focused on the development of SCENESSE® (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified a number of groups of patients with a clinical need for photoprotection and one with a need for repigmentation therapy. Currently, Clinuvel is in its final stages to complete testing of SCENESSE® in Phase II and III trials in Australia, Europe and the United States. Clinuvel's ongoing focus is to demonstrate the safety and efficacy of SCENESSE®. Pending positive clinical results, Clinuvel aims to file SCENESSE® for its first market approval for the orphan indication porphyria (EPP).

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