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Q&A: SCENESSE® successful in Phase IIa vitiligo study

Wednesday, December 19th, 2012

We’ve just released the first results from our vitiligo program which you can view online here. Following their release, we expect a number of questions from the vitiligo community, some of which we hope to address below. If you have any other questions, feel free to contact us via Facebook or email.

What was the CUV102 study?

CUV102 was an open-label Phase IIa study conducted in three US expert centres (The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, The Henry Ford Hospital in Detroit and Mount Sinai Hospital in New York). The trial was designed as a ‘proof-of-concept’: to explore the potential of SCENESSE® to repigment depigmented skin in vitiligo. In total, 54 patients enrolled in the study and 41 completed the full treatment course. All of these patients were of Fitzpatrick skin types III-VI, generally darker skin types. (more…)

Inside Clinuvel: Vitiligo and the “Michael Jackson skin disease”

Friday, November 23rd, 2012

I find vitiligo to be a fascinating, yet devastating disorder: almost overnight, patients see their skin colour erode and their identity change. Vitiligo has a serious impact on individuals and their family and professional relationships, something I’ve discussed before when looking at treatment challenges.

Because of this impact, we’ve been very careful of the way in which we discuss vitiligo publicly to ensure that, rather than adding to the distress of those affected, we can have a positive impact on disease awareness while we execute our clinical program. I’ve had the privilege to speak with individuals from a broad range of backgrounds living with, and treating, this disorder, with conversations ranging from disease impact, to treatments, to prevalence. During these discussions I also try to seek feedback on how we present the program: what we are doing and how we can do it better. This feedback has, in turn, led to changes, large and small, in our communications (and hopefully will continue to do so).

Yet, one story is often at the forefront when discussing vitiligo with investors, journalists and the broader public which we haven’t discussed until today: the case of Michael Jackson’s very public battle with vitiligo and pigment change. Often these conversations boil down quickly to the “Michael Jackson skin disease”. (more…)

Inside Clinuvel: Vitiligo and treatment frustrations

Tuesday, August 14th, 2012

Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its possible causes and how SCENESSE® (afamelanotide) may become a vital tool in a dermatologist’s arsenal for vitiligo.

We’ve also worked closely with the broader vitiligo community to better communicate the program’s goals and limitations (if you missed them, you can see the first two videos in a series of interviews between Mr Lee Thomas and our CEO here) as well as reaching out to individuals with vitiligo to better understand how this disease impacts upon lives. For me, one of the most prominent recurring topics in discussions, emails, phone calls and online is the lack of treatment for vitiligo and the frustrations of physicians and patients alike at treatment inconsistency. (more…)

Inside Clinuvel: effective drug development

Tuesday, July 31st, 2012

Take ten years, half a billion dollars and countless man hours from some of the most highly trained, intelligent individuals on the globe. You still stand a 90% chance of failure, some of which is totally out of your control. This is the apparent reality of modern drug development.

With the odds so stacked against it, it’s little wonder that the drug development sector is one requiring constant evolution in rethinking how to survive. In addition to the ‘regular’ risks of drug development, turmoil in global markets since 2007 has seen risk adverse investors shun drug development and biotechnology stocks for blue chip companies which are perceived as safer. The pressure to perform has increased for those companies who continue to work in the space.

In short, it’s forced even greater creativity to ensure survival and prosperity. (more…)

Susceptibility genes for nonsegmental vitiligo

Thursday, October 13th, 2011

Nonsegmental vitiligo is a common pigmentary disorder where the skin gradually loses its colour (melanin) in patches. It is unknown precisely what causes the condition, though it is generally thought to be a result of autoimmune damage to the pigment-producing cells, called melanocytes. Vitiligo is a complex, multifactorial disease, meaning that it occurs as a result of interactions between ones genes and their environment. The fact that vitiligo often presents in close relatives (10-30% of vitiligo patients report a family history of the disorder) indicates that, to some extent, it is a heritable condition. In other words, in some cases a person’s genetic make-up can predispose them to vitiligo. (more…)

Afamelanotide: an analogue of α-MSH designed to assist in vitiligo repigmentation

Monday, July 25th, 2011

Vitiligo is a common skin depigmentation disorder in which the melanocytes, the skin cells which produce melanin pigment, are progressively lost. Despite this, melanocyte stem cells, or immature melanocytes, are preserved in a special region within hair follicles called the bulge, or niche. Often these cells are able to be stimulated with narrowband ultraviolet B (NB-UVB) phototherapy to mature into fully functional melanocytes which migrate to the epidermis to replace the lost or damaged cells. Upon further exposure to UVB radiation, skin cells (keratinocytes) manufacture a hormone called alpha-melanocyte-stimulating hormone, or α-MSH. Alpha-MSH binds to receptors on the newly formed melanocytes and activates melanin production to repigment areas of skin affected by vitiligo. (more…)

A new treatment regime

Friday, July 15th, 2011

This is the second of a two part series on vitiligo treatment from guest blogger Liz Tyler, to read the first part, click here. Liz runs @VitiligoProject and the Vitiligo Project blog, an initiative she founded to help others, like her, who are living with vitiligo.

I’ve had vitiligo since childhood and, like many others who have the disorder, I find it a challenge to live with. Whether you’re able to accept your vitiligo or not, it’s needless to say it takes a lot of getting used to. For me, I’ve never been completely comfortable with my skin and with a career in marketing and PR, where image is really important, I’ve always been willing to try new treatments and look for therapies that could help cure it. (more…)

Diagnosis and early treatment of vitiligo

Monday, July 11th, 2011

We’re delighted to host guest blogger Liz Tyler. Liz runs @VitiligoProject and the Vitiligo Project blog, an initiative she founded to help others, like her, who are living with vitiligo. This is the first of a two part series on Liz’s personal treatment experience.

I’ve had vitiligo for thirteen years and like many, my journey of living with vitiligo hasn’t been an easy one. In this day and age when we’re all made to think we need to look like Kate Moss – it’s needless to say having patchy skin is a setback. (more…)

Follicular repigmentation in vitiligo – narrowband UVB phototherapy

Wednesday, July 6th, 2011

Figures 1 & 2. A vitiligo patient before and after NB-UVB treatment. Images courtesy of Pearl E Grimes, MD.

Vitiligo is a common skin depigmentation disorder in which the melanocytes, the skin cells which produce melanin pigment, are progressively lost. Clinically, when vitiliginous lesions (the ‘patches’ of skin which have lost their pigment) are repeatedly exposed to an intensive dose of narrowband UVB radiation (308 or 311-313nm), it is common to see small spots, sometimes described as ‘freckles’ or  ‘islands’, of repigmentation forming within the lesion. This occurs because the melanocytes producing this melanin have developed from stem cells reserved in the bulge region of the hair follicle, known as the niche. Their development is stimulated by NB-UVB and they migrate to the skin directly surrounding the hair follicle from which they were derived. As the melanocytes continue to travel through the skin and produce melanin, these ‘islands’ begin to spread and merge, eventually creating broader, but seldom perfect, repigmentation in the treated area (see Figures 1 & 2). (more…)

Melanocyte stem cells

Friday, June 17th, 2011

Human skin consists of a number of different cells. The majority of the top layer of the skin is made up of keratinocytes which are produced constantly and migrate to the surface of the skin where they ‘slough off’ as dead skin.

Melanocytes, the cells which produce pigment in the skin, lie below the keratinocytes at the base of the epidermis (see the figure, click to enlarge). Melanocytes also exist at the root of the hair follicle, in the matrix of the inner root sheath or shaft, and are responsible for giving hair its colour. The dermis, the layer of the skin beneath the epidermis, consists mostly of collagen, elastic tissue and reticulum fibres, along with some specialised nerves and glands. The bases of hair follicles are also embedded in this middle layer of skin.

(more…)

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