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
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…)
Late last week, Clinuvel attended the first ever Vitiligo World Congress (VWC) in Milan, Italy, to learn more about current issues in treating vitiligo. The VWC is an ambitious project, designed to address both physicians’ and patients’ requests for new therapies and to enhance understanding of the disease. The medical conference is the first of its kind, with one of the three days being entirely devoted to patients. (more…)
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…)
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.
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.
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.
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.
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…)
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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