UV-protective drug to be tested for vitiligo
Melbourne, Australia

SCENESSE? (afamelanotide) to be trialled as novel repigmentation therapy

A drug initially developed to protect skin from light and UV will soon be tested as a repigmentation therapy in vitiligo, a common disorder which causes skin to gradually lose its pigment or tone. SCENESSE?, a new drug developed in Australia, will be evaluated for its ability to reactivate melanin in the whitened, depigmented skin patches caused by vitiligo.

If approved by US and EU regulators, Melbourne-based Clinuvel Pharmaceuticals Ltd will commence trials in October.

"Our vitiligo program is a potential breakthrough for patients and testament to Clinuvel's expertise in the field of dermatology and skincare: the activation of melanin, pigment, in skin," Clinuvel's CEO, Dr Philippe Wolgen said.

The active ingredient in SCENESSE?, afamelanotide, works by mimicking the body's own response to ultraviolet light; activating melanin in the skin to protect against damage. The drug is delivered as an injectable implant, roughly the size of a grain of rice, and biologically activates melanin for up to 60 days.

In vitiligo the pigment producing cells of the skin (melanocytes) are absent or inadequate. As a result, lighter patches of skin appear in different parts of the body due to a lack of melanin. Vitiligo doesn't cause physical impairment but does cause significant psychological and emotional distress. The disorder affects up to 2% of the population. Nonsegmental vitiligo (NSV), the most common subtype, affects over 45 million people globally.

While testing SCENESSE? for other diseases, including skin cancer, Clinuvel discovered that the drug may help vitiligo patients.

"For a long time we were unsure of the potential of the drug in vitiligo," explained Clinuvel's Chief Scientific Officer, Dr Hank Agersborg. "But, since the scientific reports came through on the effects of phototherapy in vitiligo, we understood SCENESSE's ability to assist with repigmenting skin lesions."

SCENESSE? will be tested in a pilot NSV study on its own and in combination with an existing therapy called narrowband ultraviolet B (NB-UVB), which uses UV light to activate pigment and restore melanocytes. It is expected that SCENESSE? will enhance this therapy as well as activating melanin independently by stimulating specific melanocytes which exist in hair follicles within the skin.

"Vitiligo is a disorder that has a considerable impact on the lives of patients worldwide," Dr Wolgen said. "To be able to evaluate a potential therapy that could help improve quality of life for these people is a vastly rewarding prospect for Clinuvel.

"We are excited to be able to commence this trial and work with the vitiligo community to determine the drug's effect."

To date, SCENESSE? has been safely administered to approximately 550 patients and is in late stage confirmatory clinical trials in the US and Europe for the rare light intolerance porphyria (EPP).

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Clinuvel released a formal announcement to the ASX along with this press release. The formal release can be accessed at http://www.clinuvel.com/resources/cmsfiles/pdf/20100825CUV031Vitiligo.pdf

A short video explaining the announcement can be found here: http://bit.ly/bZ3ZPs

About SCENESSE? (afamelanotide)

SCENESSE? is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of ?-MSH, afamelanotide is a linear peptide which activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties (offering skin protection against light and UV radiation). SCENESSE? is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. For more information on SCENESSE? go to http://www.clinuvel.com/scenesse.

SCENESSE? is a registered trademark of Clinuvel Pharmaceuticals Ltd.

About vitiligo

Vitiligo is a common skin disorder in which the pigment producing cells of the skin (melanocytes) are absent or demonstrate lack of activity. As a result, lighter depigmented patches of skin (target lesions) appear in different parts of the body due the lack of melanin (pigment). The exact cause of vitiligo is unknown, but it is generally recognised that an autoimmune component plays a role in this disease. Between 0.1-2% of the global population is affected by vitiligo, affecting all races. Vitiligo causes significant psychological and emotional distress.

Vitiligo is traditionally separated into two clinical forms: nonsegmental, or generalised, vitiligo (NSV) and segmental vitiligo (SV), which present with distinctive clinical features and natural histories.

NSV is the most common form of the disease, accounting for 72-95% of the cases. The vitiliginous lesions are usually symmetrically distributed and new patches may appear throughout the patient's life. The disease is progressive with flare-ups. NSV is frequently associated with personal or family history of auto-immunity.

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).

Clinuvel is currently testing SCENESSE? in four clinical indications:

Indication

Description

Clinical Trial Status

Erythropoietic Protoporphyria
(EPP)

Absolute sun/UV intolerance

Phase III trial full results reported July 2010

Confirmatory Phase III trial approved August 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

Polymorphic Light Eruption
(PLE / PMLE)

Severe sun/UV poisoning

Phase III trial preliminary results reported December 2009

Nonsegmental Vitiligo (NSV)

Pigmentary disorder

Phase II pilot trial to commence in 2010

Phase I and II human clinical trials using SCENESSE? have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date. Following successful conclusion of the development program, Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE?.

For more information go to http://www.clinuvel.com .

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