Scenesse Starts Phase III Trials for EPP in the US


News today that Scenesse has progressed another step towards wider approval with the commencement of Phase III Trials.

About 100 people with the condition Erythropoietic Protoporphyria (EPP) will be double blinded to receive the Scenesse implant or placebo. Their ability to tolerate sunlight will then be measured.

The trials will take place in Alabama, California, Michigan, New York, North Carolina, Texas and Utah.

Normally, EPP sufferers might expect to experience pain and phototoxic reactions when exposed to direct sunlight.

The aim of these Phase III trials will be confirm the efficacy and safety of previous trials, but on a larger scale.

Clinuvel commences US Phase III trial of SCENESSE® in rare light and UV disorder

Melbourne, Australia and Baar, Switzerland, May 22 2012

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has commenced its confirmatory Phase III US study of the novel drug SCENESSE® (afamelanotide) in patients diagnosed with the rare light intolerance disorder erythropoietic protoporphyria (EPP). The six-month, randomised, multicentre, double-blind, placebo-controlled study (CUV039) will recruit up to 100 adult EPP patients in seven specialist centres (Alabama, California, Michigan, New York, North Carolina, Texas and Utah).

Scenesse is already available in Italy as a treatment for EPP but is yet to be approved by FDA.

Scenesse has been granted orphan drug status in order to allow a streamlined approval process. This designated has been granted because it can treat certain rare diseases that are not currently well covered by existing options.

The technology behind Scenesse, that is the photo-protective properties of afamelanotide, are of interest to rosacea sufferers, especially those for whom the sun is a major trigger. So far, though no development effort targeted at rosacea has been undertaken by Clinuvel.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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