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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…)

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…)

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…)

British Skin Foundation scratches the surface

Friday, September 16th, 2011

In a striking new campaign, the British Skin Foundation have teamed up with photographer Rankin to try and visualise the physical and emotional impact that skin diseases can have on individuals.

Launched earlier this week at London’s National Portrait Gallery, the works posted online feature models crawling with bugs, with cracked and dried skin and covered in barbed wire. For many living with skin disorders such sensations can feel all too familiar, although the symptoms aren’t always visible. (more…)

Study: pharma ads failing FDA guidelines

Thursday, August 25th, 2011

The marketing model for US prescription pharmaceuticals is often debated for its direct-to-consumer (DTC) advertising as the United States is one of the few jurisdictions globally which allows this type of marketing. Yet equally debated is promotion directly to physicians, key decision makers in the prescription process. Physician promotion comes in many forms, ranging from one on one visits with sales representatives to educational sponsorship to the ubiquitous branded pen. (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…)

Can Vitamin D Prevent Diabetes?

Friday, August 5th, 2011

Recently, Vitamin D has gained a lot of interest for its potential to prevent chronic diseases. The latest article released this year by Mitri et al., linking the risk of diabetes to low levels of vitamin D in the body, has created media speculation about the potential of vitamin D to help prevent diabetes.

(more…)

The importance of clinical relevance

Tuesday, August 2nd, 2011

Development of novel drugs is truly like no other business: one attempts to address questions that may have never been previously posed – let alone answered – in the pursuit of improving the lives and quality of life of patients. As I eluded to in my recent letter to shareholders, the team is now well into the analysis of results from our erythropoietic protoporphyria (EPP) program; two studies from the US and Europe. This is a complex and time consuming task that requires one to collate and make sense of thousands of data points to answer a seemingly straight forward question: does this trial show that the drug is safe and effective?

Obtaining an answer needs to be understood from the concept of clinical relevance. Put simply, results don’t just need to show that a treatment or intervention has an effect on a disease. Rather, they need to indicate that that effect is relevant to the current clinical understanding, treatment and care for the disease or indication. They need to show that the drug’s effect is having a positive, meaningful impact upon a patient’s prognosis and care. This is a crucial point to consider in the development of protocols and in the careful analysis of results, as it is how regulators will review the results. (more…)

Susceptibility genes for nonsegmental vitiligo

British Skin Foundation scratches the surface

Study: pharma ads failing FDA guidelines

Can Vitamin D Prevent Diabetes?

The importance of clinical relevance

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