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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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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The Melanocortin-1 Receptor (MC1R) and allelic variations

Thursday, July 1st, 2010

Red Hair from  derekGavey

Yesterday, Clinuvel announced the grant of a new patent from the USPTO – allowing the company exclusive protection for the use of afamelanotide (SCENESSE®) and any molecule belonging to the family of melanocortins for UV-protection of individuals who are at high risk of skin cancers. This patent, granting protection until 2024, refers specifically to individuals with defects (allelic variations) seen in the melanocortin-1 receptor (MC1R). The MC1R plays a key role in the pigmentary response and defensive mechanism to UV.

The MC1R is vital in regulating the quantity of melanin in skin and an individual’s pigmentary response; one’s ability to activate the protective dark pigment eumelanin in skin after UV induced skin damage (also known as the ‘tanning response’ after erythema).Allelic variations of the MC1R – of which there are over 80 identified in medical literature – are considered highly prevalent in fair skinned populations of European descent, with reports of up to 75% prevalence in Ireland. In red haired coloured (RHC) individuals single or multiple variations are seen in 93% of people tested. Conversely, variations are not seen in African populations, rather a wild type MC1R is referred to in those with darker skin. (more…)

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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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The concept of senescence

Tuesday, May 18th, 2010

The human body functions and survives by maintaining a biological and physiological balance. Over tens of thousands of generations we have evolved numerous systems to care for and protect our health and well being at a cellular level.

As a response to damage, various cells are programmed to self-destruct. The process is known as apoptosis, and it works to ensure that defects to the nucleus of the cell arising from any damage are not replicated and passed on in subsequent generations of cells.

A second, and lesser known process, is the concept of senescence.

(more…)

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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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