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.
Summary of today’s announcements
Wednesday, July 14th, 2010Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®
Friday, July 9th, 2010Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.
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.
The Melanocortin-1 Receptor (MC1R) and allelic variations
Thursday, July 1st, 2010
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…)
Online updates and more digital development
Tuesday, June 1st, 2010Although 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.
“A fantastic outcome for Clinuvel”
Wednesday, May 19th, 2010Following 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
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.
News from Italy and the launch of our brand
Tuesday, May 18th, 2010The 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.
Introduction to the melanocortin system
Wednesday, February 24th, 2010
The body consists of cells which communicate with each other via signaling molecules to govern and determine a variety of physiological functions in the body. The action and effect of these signaling molecules is mediated by ‘receptors’ which are located on the surface of (plasma membrane), or inside a cell. A molecule that ‘binds’ with a receptor is known as a ligand and can be protein such as a hormone or drug and the role of the ligand is to activate, or inactivate a particular biological activity.
In some ways receptors can be likened to switches with on and off positions, and which in turn affect the cell’s internal functioning. The action or inaction of receptors is determined by the type of ligand with which they bind, i.e. receptors are activated when an agonising ligand, an ‘agonist’ binds and left inactive when an ‘antagonist’ in some way prevents the agonist from binding. The specific biological action is dependent upon which particular ligand binds with a receptor.
Understanding clinical trial results – P values
Friday, December 11th, 2009
Clinical trials are complicated and often the results can be even more so. Close monitoring of the interactions between patients, diseases, conditions and drugs for extended periods of time and the various questions posed in order to prove or disprove safety and efficacy of particular treatments result in an accurate yet highly complex mountain of data.
Clinical trials are conducted to answer a specific question about a treatment, usually related to safety and efficacy. This involves the development of a hypothesis, and then the running of clinical trials to collect data and to demonstrate the validity of the hypothesis using statistical analysis.
