Compassionate use – navigating the regulatory landscape to ‘do good’

Friday, December 3rd, 2010

As snow begins to fall around Clinuvel’s European office, the team in Australia is preparing for a long hot summer. The seasons are at the forefront of our minds at Clinuvel, since our lead drug SCENESSE® appears to have a dramatic impact on the ability of patients to expose themselves to sun. We try to test the drug under the most extreme conditions, meaning trials must be conducted in spring and summer. As the seasons change, we begin to see more requests and enquiries from the southern hemisphere, in particular from patients with erythropoietic protoporphyria (EPP), seeking access to the drug outside of formal trial programs. (more…)

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A new program for SCENESSE®: nonsegmental vitiligo

Wednesday, August 25th, 2010

A patient with vitiliginous lesions on their fingers and hands

Today Clinuvel has announced that it will be commencing a new program for SCENESSE® in the common pigmentary disorder vitiligo. While this is an exciting development for Clinuvel – increasing the potential for SCENESSE® as a therapy – we feel it is vital to provide as much in-depth information on our program as is feasible to ensure our stakeholders are aware of what we anticipate will and will not be achieved with SCENESSE® as a repigmentation therapy. (more…)

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Pain measurement in clinical studies: The Likert Scale

Friday, August 13th, 2010

surveyWhen assessing new therapeutic goods through clinical trials, researchers must obtain information on the degree of a patient’s physical response to therapy. This data then undergoes detailed statistical analyses in order to determine the safety and efficacy (effectiveness) of the drug or treatment.

Central to Clinuvel’s clinical trial design, and the value of these studies, is measurement of the severity of phototoxic reactions (adverse reactions to light or UV radiation) in trial patients. In order to do this accurately, a symptom severity scale has been developed based on the method of ‘Likert scaling’.

(more…)

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Summary of today’s announcements

Wednesday, July 14th, 2010

Today’s announcement of the results of CUV017 has brought with it a stream of updates from Clinuvel, on the website, YouTube and beyond.

In this post we summarise the days releases and developments.

(more…)

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What makes a ‘gold standard’ in cGMP? (plus a new webcast)

Monday, July 12th, 2010

As previously discussed on the blog, Good Manufacturing Practice, or GMP is a vital consideration for pharmaceutical manufacture and quality control. This means that the processes, equipment, active ingredients, documentation and training are controlled and of a high standard prior to a drug being approved. To be in compliance with GMP, regulations should ensure that the drug substance is of adequate quality, when used in humans and becomes available commercially.

Ultimately, quality protects the public and ensures that the reality of a drug sold or prescribed is an accurate reflection of the claims and ingredients made not only on the label, but also of the exact nature of the formulation that was approved through rigorous clinical trials and analysis.

(more…)

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Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®

Friday, July 9th, 2010

Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.

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Necessary innovation: the vital role of manufacturing in pharmaceutical development

Thursday, July 8th, 2010

This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.

(more…)

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Online updates and more digital development

Tuesday, June 1st, 2010

Although we’ve been a little quiet this week on the blog, a number of updates have been made to the main site as part of our ongoing commitment to improving our online presence.

We’ve added a new, expanded article on melanoma, improved our article on skin cancer and organ transplant patients to include information on vitamin D deficiency.

We’ve also produced two short educational videos on the topics of skin and skin types. These now form a key part of the articles on Skin and the Function of Skin Pigment sections on our new website.

In the coming months we will produce and release more of these videos explaining the science, technology and concepts that  influence, underpin and drive Clinuvel and our proprietary first-in-class medicinal photoprotective drug, Scenesse.

You may also have noticed that we have updated the visual design of the blog, making it more engaging, easy to use and also easier to share and interact with us on Twitter and Facebook.

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“A fantastic outcome for Clinuvel”

Wednesday, May 19th, 2010

Following two important announcements, we spoke yesterday with Clinuvel Non-Executive Director, Dr Roger Aston. We asked Dr Aston to draw upon his experiences within the international pharmaceutical and life sciences industries to provide context to the company’s news.

Listen to the entire webcast here

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News from Italy and the launch of our brand

Tuesday, May 18th, 2010

The market entry of afamelanotide as a first-in-class drug is the culmination of a decade long R&D program, and most of all signifies Clinuvel’s ability to focus.

It is most important to communicate afamelanotide’s novel pharmaceutical properties and its clinical effects. Here we worked for over 2 years with various groups and third parties and agencies to align all views, whereby clear product differentiation was key in our choices.

(more…)

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