MAA: a moment in Clinuvel’s EPP story

Thursday, February 9th, 2012

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…)

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Online evolution

Thursday, December 15th, 2011

Earlier this week we unveiled a major update to our online presence with the release of our new-look website and the launch of Mothers & Children, a new site focusing on the pediatric and parental skincare.

Over the past five years the team has worked to continuously improve our online resources, expand into social media and build our presence on our Youtube channel (generating over 100,000 views in the process). The new site, Mothers & Children, is a direct response to what we saw as a key gap in online skincare information: up-to-date, accurate and concise information on caring for and protecting young and maternal skin. This is a new space for us and we’re excited to be able to compliment our extensive Science of Skin resources with this site.

We’re not standing still online. You will notice further changes in the coming months as they emerge from internal development and testing as well as new content being developed across the site.

Let us know your thoughts about our new site via Twitter, Facebook or email.

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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…)

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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…)

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Porphyrias: a disease grouping by cause, not symptoms

Monday, April 18th, 2011

Held biennially, the Porphyrins & Porphyrias conference (P&P) is the world’s largest gathering on the porphyrias – a group of metabolic disorders causing biochemical disruptions in the pathway of the body which synthesizes haem (heme).

As a result of each of these disruptions, the body presents with unique symptoms ranging from skin symptoms and phototoxicity – as those seen in erythropoietic protoporphyria and congenital erythropoietic porphyria – through to acute attacks of abdominal pain, seen most commonly in acute intermittent porphyria. In short, no two porphyrias are clinically identical yet they are discussed as a single group of disorders with a similar cause. As a matter of fact, there are eight variations of porphyrias, each with a specific clinical manifestation of disease. (more…)

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‘Measuring’ vitiligo: the challenges of clinical and treatment evaluation

Monday, April 4th, 2011

Since our announcement last year that Clinuvel would commence a new program for SCENESSE® (afamelanotide) in nonsegmental vitiligo, the company has received vast interest in the application of the drug in this disease. Of the enquiries that best captured the essence of this program, one stood out: a US based analyst asked how the company intended to objectively measure the response to treatment, the repigmentation of vitiliginous lesions, in its trial. (more…)

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A clinical success: study retention rates

Thursday, February 10th, 2011

We were delighted this week to be able to announce the successful completion of our first Phase II study conducted in the US, a placebo controlled, randomised trial of SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP) (CUV030). (more…)

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Vitiligo, light therapy and stem cells: a new webcast online

Wednesday, January 12th, 2011
Vitiligo Narrowband UVB treatment

Vitiligo Narrowband UVB treatment

Today we’ve released our first new video webcast for the year, explaining the theory of repigmentation in vitiligo with narrowband UVB (NB-UVB) phototherapy in greater detail. You can view the new video on our website or on Youtube.

(more…)

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Time to look forward

Monday, December 20th, 2010

Many of you who follow the company closely will notice the increase in communications in recent weeks. As our clinical and regulatory workload increases behind the scenes, it is our intention to keep our numerous stakeholders abreast of relevant updates in the field and with Clinuvel’s work.

While it is commonplace to review the year past during the festive season, I take this time to indulge in the progress and challenges that lie ahead for Clinuvel. (more…)

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An update on phototherapy

Friday, December 10th, 2010

Those who follow the company’s clinical announcements would be well aware of our recently announced vitiligo program. To provide a deeper understanding of the science and the concept of phototherapy, today we’ve released a second technology update focused on exploring narrowband UVB technology. See our main site:

Technology Update II: Afamelanotide as an adjunct to phototherapy

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