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Clinuvel announces PLE Phase III preliminary results

Clinuvel announces PLE Phase III preliminary results Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide

Melbourne, Australia 18th December 2009 - 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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About Polymorphic Light Eruption (PLE/PMLE) PLE is the most common recurrent photodermatosis causing sensitivity and, after sunburn (solar erythema), is the most common sun-related problem seen by physicians. PLE is a distressing seasonal skin condition with episodes typically beginning in spring and resolving by late-summer or autumn, and symptoms include non-scarring, burning red papules, vesicles or plaques which appear on sun-exposed skin 30 minutes to several hours following exposure to sunlight.

Appendix I (Following Code of Best Practice, ASX)

Name of trial CUV015. A Phase III, Randomised, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide in Patients Diagnosed With Polymorphic Light Eruption (PLE).

Primary study objectives a) To evaluate whether afamelanotide* prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE; b) To evaluate the effect of afamelanotide on the use of rescue medications (i.e. corticosteroids, anti-inflammatory drugs).

Secondary study objectives a) To evaluate the safety and tolerability of afamelanotide* in this specific clinical setting; b) To evaluate the effect of afamelanotide on melanin density levels as measured by skin reflectance; c) To evaluate whether afamelanotide has a beneficial effect on the quality of life of patients with a documented history of PLE; d) To determine other factors of influence to the severity of PLE symptoms e.g. sun exposure and use of sun protection methods

Blinding status Double-blind.

Product Development Status Good Manufacturing Practice (GMP) Standard.

Treatment method, frequency, dose levels 3 implants (20 mg afamelanotide or placebo) administered subcutaneously.

Number of patients 36 patients.

Patient selection criteria a) Well documented history of moderate/severe PLE as diagnosed/confirmed by a photo dermatologist or photo biologist. Newly diagnosed patients with moderate/severe PLE may be included if patient numbers earlier known to the clinic are limited, provided confirmed diagnosis by a specialist; b) Recurrent episodes that occur at least once per year, developing in country of domicile and same latitude (to exclude patients affected only when travelling to sunnier destinations); c) Have provided written informed consent to participate in the study; d) Aged 18 - 70 years at inclusion.

Trial location Multicentre trial in Europe and Australia.

Duration of the trial Approximately 18 months.

Trial standard In compliance with Good Clinical Practices (GCP) and ICH guidelines.

* formerly CUV1647

Appendix II: About afamelanotide Afamelanotide is a first-in-line therapeutic being developed by Clinuvel. An analogue of α-MSH, afamelanotide is a linear peptide which activates the skin to activate and produce eumelanin, the dark pigment which is known to have photoprotective properties (providing skin protection against light and UV radiation). Increased pigmentation of the skin appears a few days after administration of afamelanotide and lasts up to 60 days. Afamelanotide is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice.

About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of afamelanotide, its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection. Currently, Clinuvel is in its final stages to complete testing of afamelanotide in Phase II and III trials in Australia and Europe. Clinuvel’s ongoing focus is to demonstrate the safety and efficacy of afamelanotide. Pending positive clinical results, Clinuvel aims to file afamelanotide for its first market approval for the orphan indications porphyria (EPP) and solar urticaria (SU).

Clinuvel is currently testing afamelanotide in five clinical indications:



Clinical Trial Status

Erythropoietic Protoporphyria (EPP)

Absolute sun/UV intolerance

Phase III trial preliminary results due Confirmatory Phase III trial in Europe approved August 2009

Polymorphic Light Eruption (PLE / PMLE)

Severe sun/UV poisoning

Phase III trial preliminary results reported December 2009

Actinic Keratosis (AK) and Squamous Cell Carcinoma (SCC) in Organ Transplant Recipients (OTRs)

Skin cancer in transplant patients

Phase II trial started October 2007

Solar Urticaria (SU)

Acute anaphylactic reaction to sun/UV

Phase II trial results reported July 2009

Photodynamic Therapy (PDT) - systemic

Phototoxicity following cancer treatment

Phase II trial results reported December 2009

Phase I, II and III human clinical trials using afamelanotide have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.

During the development program Clinuvel is working closely with global regulators to facilitate marketing approval of afamelanotide.

For more information contact: Lachlan Hay Head of Global Network and Communications Clinuvel Pharmaceuticals Limited T: +61 3 9660 4900 E:

Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, 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 afamelanotide can or will be achieved; · no assurances can be given by Clinuvel that, even if its development programme for afamelanotide 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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Posted: December 2009