Clinuvel Completes First Phase II US Study

Published: Feb 09, 2011

Wednesday 9th February 2011 - Baar, Switzerland and Melbourne, Australia -- Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that all patient visits for its first US Phase II study (CUV030) of the novel photoprotective drug afamelanotide (known as SCENESSE®) had been completed, and analysis of the study outcomes was underway.

The six month, randomised, placebo-controlled US study was designed to further evaluate the safety and efficacy of SCENESSE® in reducing the number and severity of phototoxic skin reactions in patients with the rare light intolerance disorder erythropoietic protoporphyria (EPP). Phase II and III studies evaluating SCENESSE® in EPP (CUV010 and CUV017) have been completed in Europe and Australia and a confirmatory Phase III study (CUV029) is underway in Europe.

EPP is characterised by severe phototoxicity of the skin resulting in intolerable pain, swelling, and scarring, usually of the exposed areas such as the face, hands and feet. EPP patients are often forced to lead an indoors existence, severely affecting their quality of life. Approximately 10,000 people globally are affected by EPP, an estimated 4,000 in the US. Afamelanotide was granted orphan drug status in Europe and the US for EPP in 2008.

Across six expert porphyria centres (Alabama, California, New York, North Carolina, Texas and Utah) 70 of the 77 EPP patients (91%) completed the CUV030 study, exceeding initial recruitment targets. Patients were administered either the afamelanotide implant or a placebo, two parallel study groups, every two months and asked to record the number and severity of reactions experienced as well as the duration of time they spent outside, exposing their skin to sunlight.

In three of the study sites objective photoprovocation testing was also conducted. In this procedure an exact artificial light source was used to clinically measure the time required to elicit a phototoxic response in patients’ skin under standardised laboratory conditions. Importantly, no drug related serious adverse events have been identified to date.

“Although this study has been conducted in the US we will evaluate these results and, if they add to the body of evidence that afamelanotide is safe and effective in EPP, include them together with CUV010, CUV017, and the anticipated CUV029 study in the European dossier to obtain marketing authorisation,” Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said.

Clinuvel’s CEO, Dr Philippe Wolgen, said the company would now work closely with its data management provider to analyse and deliver statistical results from the CUV030 study.

“Due to the lack of effective treatments in EPP and strong demand expressed by patients participating in this study, Clinuvel is in discussion with the US Food and Drug Administration (FDA) to facilitate further drug access for EPP patients.

“We would like to be able to extend active treatment with afamelanotide to all US patients who completed the CUV030 trial for the spring and summer. Extended treatment under follow-on protocols has played an important role in our global EPP program and we would want this to continue in the US for the benefit of the patients,” Dr Wolgen said.

About Clinuvel Pharmaceuticals Limited

Clinuvel Pharmaceuticals Ltd 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).

SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd.

For more information contact:

Lachlan Hay Head of Global Network and Communications, Media Communications & IT Team Clinuvel AG Neuhofstrasse 3D 6340 Baar Switzerland Tel: +41 41 767 45 45 Fax: +41 41 767 45 46 Mobile +41 79 963 3230 Twitter @ClinuvelNews | Facebook The Photoprotection Network | Online

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