Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first official filing for SCENESSE® (afamelanotide) with the European Medicines Agency. It has taken our teams around six years to arrive at this point. Benchmarked against peer companies, it is a relatively swift development path for a first-in-class drug; we first publicly announced our erythropoietic protoporphyria (EPP) program in September 2006. It is an opportune moment to reflect briefly on how we reached this milestone and then discuss the steps that must be taken from here. (more…)
MAA: a moment in Clinuvel’s EPP story
Thursday, February 9th, 2012Low sunscreen use, high melanoma rates: a breakdown of the sunsmart message?
Tuesday, January 24th, 2012
It’s estimated that more than 9,000 Americans will die from melanoma this year and 76,000 new cases of the disease will be diagnosed. Melanoma, an aggressive skin cancer which can spread (metastasize) quickly to other parts of the body, is also the second most common form of cancer in young Americans (those aged 15-29).
Overexposure of skin to ultraviolet (UV) radiation significantly increases an individual’s risk of melanoma, particularly at a young age; just one severe sunburn in childhood can double the lifetime risk of melanoma. Sun protective measures such as clothing and sunscreen are seen as key to reducing melanoma risk. (more…)
EPP results and clinical relevance
Friday, November 4th, 2011
A protoporphyrin IX molecule
Over recent months I have written several times of the need for Clinuvel to prove clinical relevance in our trials with the use of SCENESSE® (afamelanotide) in erythropoietic protoporphyria (EPP). In orphan populations the need to demonstrate how a novel drug assists in their daily activities and improve their lives is at the forefront of the regulators’ minds. And so it should be, after all the objective of the pharmaceutical industry is to develop drugs which address either disease or symptoms adequately and safely. The results the company released yesterday from our Phase II US study of the drug in EPP (CUV030) have given us important data towards demonstrating clinically relevant improvement of patients’ lives. (more…)
Ultraviolet A more cancer-causing than once thought
Tuesday, October 18th, 2011
While the evidence linking sunbeds to the development of skin cancer continues to mount, recent research provides new insight into the underlying mechanisms.
Radiation from both the sun and tanning beds is made up of various wavelengths, including visible light and several types of ultraviolet (UV) radiation. Ultraviolet B (UVB) rays, those which cause sunburn, have long been heralded the culprit which initiates skin cancer. It does this by damaging the genetic information (DNA) within skin cells, forming lesions known as cyclobutane pyrimidine dimers (CPDs) and pyrimidine (6-4) pyrimidone photoproducts (6-4PPs). These lesions create mutations in the DNA which can lead to the development of skin cancer (you can read about this process here). (more…)
Children at greater risk of melanoma spreading
Tuesday, October 11th, 2011
A recent study of melanoma in children and young adults indicates that there may be greater risk of metastasis, or spread, of the cancer in younger patients. The study, conducted by researchers at Baltimore’s John Hopkins Children’s Center, involved analysis of 2008 SEER (Surveillance, Epidemiology, and End Results) data on melanoma cases from 2003 to 2008. A total of 717 children and 1368 adults, aged 20-24, were diagnosed during this time.
Investigators looked at patients who received biopsies of the sentinel lymph nodes (SLN; those nearby the initial tumour) and the number of those in whom the disease had spread to this site. It was found that, of those biopsied, children were more likely to have cancer cells which had infiltrated the removed lymph nodes (25%), indicating greater rates of metastases than in adult patients (14%). (more…)
Clinical relevance – the value of patient experiences
Friday, September 30th, 2011
Since 2006 Clinuvel has trialed SCENESSE® in a truly unique group of individuals: patients living with erythropoietic protoporphyria (EPP), a rare genetic blood disorder which causes an absolute intolerance to light.
EPP prevents patients from leading ‘normal’ lives, especially outdoors. It is one of the few diseases that manifest clinically with initially invisible symptoms which cause severe dermal pain for several days. This not only presents a challenge for diagnosis and treatment, but also for generating meaningful clinical trial results – those which are measurable numerically and are used by regulatory authorities to evaluate the efficacy of a drug in a patient population. Here, real life patient experiences during a trial can play an important role in providing clinical relevance and analysing hard data. (more…)
A coffee a day keeps skin cancer at bay? Look a little deeper…
Thursday, August 18th, 2011
We tweeted it earlier this week and it’s been run across numerous news sites: new research has suggested that coffee – or more specifically caffeine – can help reduce the risk of skin cancer. It’s a fascinating story and one which deserves further review.
The research, conducted across multiple US sites and supported by National Institutes of Health grants, sought to expand upon an existing understanding of the correlation between the intake of caffeinated beverages and a decrease in the incidence of non-melanoma skin cancers. (more…)
Ultraviolet radiation and its effects on the skin
Wednesday, June 22nd, 2011
Ultraviolet (UV) radiation forms part of the electromagnetic spectrum between visible light and X-rays; it is invisible to the human eye. UV light can be separated into three bands, UVA (400-320nm), UVB (320-290nm) and UVC (290-100nm). Of the UV radiation that reaches the Earth’s surface from the sun, approximately 6% is UVB and 94% UVA.
Skin maintains a curious balance with UV radiation. When UV impacts upon skin, the various wavelengths of light penetrate to different levels and thus have a number of effects.
Dear 16-year-old Me
Thursday, May 5th, 2011A great new viral video from the David Cornfield Melanoma Fund went live earlier this week. Check it out:
Head to the DCMF website for more on their work. You can read more about melanoma on our website.
Melanoma/Skin Cancer Detection and Prevention Month
Tuesday, May 3rd, 2011
May is Melanoma/Skin Cancer Detection and Prevention Month in the US, and with summer just around the corner in the northern hemisphere, this is a timely reminder of the dangers of unprotected UV exposure.
Skin cancer is one of the most common forms of cancer in America, with more than 3 million cases diagnosed each year and over 10,000 deaths from the disease. Worryingly, unlike most forms of cancer which are declining, skin cancer rates in America are on the rise. There are three common types of skin cancer – basal cell carcinoma, squamous cell carcinoma and melanoma. Of these, melanoma is the least common, and yet the most frequently lethal form. (more…)



