Friday, 18 December 2009 11:00

Clinuvel announces PLE Phase III preliminary results

Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained preliminary results in its multicenter randomised double-blind placebo controlled PLE study (CUV015) evaluating the safety and efficacy of afamelanotide 20 mg implants. PLE is a recurrent seasonal UV-related skin disorder seen mostly in fair-skinned patients (10-20% incidence) in the northern hemisphere.

Preliminary evaluation of 36 patients with recurrent PLE revealed a trend toward reduction of characteristic dermal symptoms. Analysis of the physician’s Global Severity Index during the 120 days and 150 days of seasonal treatment demonstrated a reduction in severity of symptoms in patients receiving afamelanotide compared to placebo (p=0.448 and p=0.077). In all sun exposed areas of the skin tested, compared to starting values, an increase in melanin density was found at 120 days (p=0.009) and 150 days (p=0.007) indicating a strong elevation in melanin density in phototype I and II patients during spring and summer. Overall the safety profile of afamelanotide administered during the trial was good.

Positive reports from leading academic dermatologists in the trial form the basis for further testing of afamelanotide 16 mg as final commercial product. A 2-dose randomised placebo-controlled Phase III trial (CUV032) over the seasons (March-October 2010) will be conducted, and 40-50 Caucasian patients with severe and recurrent PLE are currently being selected in 5 European academic centres. All data from this study and other trials currently in progress will further support the final registration dossier of afamelanotide in erythropoietic protoporphyria (EPP) and solar urticaria (SU) in Europe and Australia.

Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said: “The PLE results fit well in the pharmacological context of afamelanotide’s development program as a novel therapy in light and UV related skin disorders. Based on my recent interaction and long experience with US and EU regulators, all preclinical and clinical data seen give me the confidence that Clinuvel is edging towards successful regulatory review.”

“It is clinically reassuring to have seen more than 600 patients in our trials and to monitor an additional 150 patients currently receiving the drug. Clinuvel’s primary focus is on preparing a regulatory dossier for two orphan indications EPP and SU; the safety and efficacy data from PLE, a common photodermatosis, will enhance that process.”

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Investor relations contacts:

Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900
Europe: Clinuvel AG, T: +41 41 767 45 45
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Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:

  • actual results may and often will differ materially from these forward-looking statements;
  • no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved;
  • no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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