Xeroderma Pigmentosum

MALIBU, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Leading biotech company CLINUVEL last week joined an intimate event bringing together California’s most prolific investors and philanthropists at the Malibu home of Lady Gaga and Michael Polansky. The event, hosted by Lady Gaga and Mr. Polansky, and Sean Parker and Alexandra Parker, shone a light on the groundbreaking work of CLINUVEL, a global biopharmaceutical firm whose cutting-edge melanocortin therapies transform the lives of patients at the highest risk of photodamage and skin cancer. Mr. Parker and Mr. Polansky have supported CLINUVEL for more than 15 years, finding alignment between the Company’s pioneering approach to medicine and the boundary-pushing work of the Parker Institute for Cancer Immunotherapy which works to revolutionise healthcare. Over a family-style dinner by chef Evan Funke of Los Angeles hotspot Felix Trattoria, and a performance by Grammy-winning Attacca Quartet, the hosts shared how CLINUVEL’s treatments herald a new era for the treatment of light-related conditions. The Group’s CEO Dr. Philippe Wolgen also unveiled what is next for the most exciting biopharmaceutical firm in the field of photomedicine today. The future of photomedicine For 25 years, CLINUVEL introduced a proof of concept by treating groups of patients whose needs had been overlooked by the pharmaceutical industry. These include the genetic disorders erythropoietic protoporphyria (EPP), xeroderma pigmentosum (XP) and the skin disorder vitiligo, when people lose their pigmentation. In 2014 CLINUVEL developed the only approved treatment in the world for EPP, accelerating CLINUVEL’s evolution into a profitable, self-sustaining and dynamic company. Now the Company is exploring the vast potential of its technology: how can CLINUVEL’s unique knowledge of melanocortins be scaled up to treat widespread health conditions that affect the skin, brain and nervous system? Beyond the world of pharmaceuticals, CLINUVEL’s technology has the power to disrupt the skincare market. After 43 years of photomedicine research, the Company is launching PhotoCosmetics, a range of advanced skincare products based on a group of peptides known as melanocortins. Revolutionising healthcare for those in needPhilanthropy is central to the work of Lady Gaga and Michael Polansky, Sean Parker and Alexandra Parker. CLINUVEL shares their passion for creating long-lasting change and radically improving patients’ lives. At the event in Malibu, CLINUVEL announced the Photomedicine Foundation, which will count Mr Polansky as a trustee. The initiative will help those most affected by debilitating conditions related to the sun. Through the Foundation, CLINUVEL is taking its world-leading expertise directly to communities who cannot afford care or treatment. The foundation’s mission is to support vulnerable patients at extreme risk of photodamage and skin cancer in Africa, Middle East and Latin America. Michael Polansky said: “It’s critical that investors strive to find companies whose missions extend beyond profitability, by supporting the development of technologies that can drive meaningful and sustained improvement to human life. CLINUVEL is an example of a company that aims to improve human health and I am delighted to become a trustee of the Photomedicine Foundation, which will play a vital role in improving the lives of individuals with light-related conditions who cannot access life-saving medical care.” Sean Parker said: “CLINUVEL is one of the most innovative Life Sciences companies that exists today with a management that has the patience to see through long development. Both its groundbreaking melanocortin technology and long-term business plan will disrupt the world of biopharmaceuticals and luxury skincare. The Photomedicine Foundation is a welcome addition to a company on a path to growth unlike any other.” CLINUVEL’s CEO, Dr. Philippe Wolgen said: “Sean Parker and Michael Polansky are unafraid to rip up the rulebook in their mission to advance science and improve global health. CLINUVEL is grateful to have their support as we translate our pharmaceutical technology into PhotoCosmetics and give back to underserved communities. A bright future looms for CLINUVEL.” About The CLINUVEL Group: CLINUVEL is a public biopharmaceutical company whose pioneering melanocortin technology has revolutionised the field of photomedicine. Over the last 25 years, CLINUVEL’s work has furthered scientific knowledge, delivered breakthroughs in medical technology and transformed patients’ lives. The Company has developed and commercialised SCENESSE® (afamelanotide), the only approved treatment in the world for the prevention of phototoxicity in adult patients with EPP. The treatment was approved for use by the US FDA in 2019 and is also approved for commercial distribution in Europe, Israel and Australia. CLINUVEL is conducting clinical trials to assess the efficacy and safety of its melanocortin technology in treating severe disorders including xeroderma pigmentosum (XP), vitiligo and arterial ischemic stroke. In 2023 it announced its expansion into skincare with the introduction of its first PhotoCosmetic product CYACÊLLE, a polychromatic solar screen. For more information visit www.clinuvel.comInstagram:@clinuvel_pharmaceuticals @clinuvelDNATwitter:@ClinuvelNewsFacebook:@Clinuvel

BERLIN, Oct. 10, 2023 /PRNewswire/ -- Non-melanoma skin cancer (NMSC) is causing a greater number of global deaths than melanoma, the more serious form of skin cancer, a new study presented today at the EADV Congress 2023 has found. Researchers also believe that NMSC is underreported and that the true impact of this disease may be even higher than estimated. Professor Thierry Passeron, lead author of the study, explains, "Although NMSC is less likely to be fatal than melanoma skin cancer, its prevalence is strikingly higher. In 2020, NMSC accounted for 78% of all skin cancer cases, resulting in over 63,700 deaths. In contrast, melanoma caused an estimated 57,000 fatalities in the same year. The significantly higher incidence of NMSC has, therefore, led to a more substantial overall impact." Professor Passeron adds, "As alarming as these figures are, they may, in fact, be underestimated. NMSC is often underreported in cancer registries, making it challenging to understand the true burden." The researchers also identified specific population groups that were more at risk of this disease, including people who work outside, organ transplant recipients and those who have the skin condition xeroderma pigmentosum. The study, which utilised data from the World Health Organization International Agency for Research on Cancer, found a high incidence of skin cancer in fair-skinned and elderly populations from the USA, Germany, UK, France, Australia and Italy. However, even countries with a high proportion of dark phenotypes were not immune to the risk of death from skin cancer. In 2020, there were nearly 1.2 million reported cases of NMSC worldwide compared with 324,635 cases of melanoma. The majority of skin cancer occurrences are non-melanoma, referring to a group of cancers that slowly develop in the upper layers of the skin, with common types including basal cell carcinoma and squamous cell carcinoma. Professor Passeron comments, "We have to get the message out that not only melanoma can be fatal, but NMSC also. It's crucial to note that individuals with melanin rich skin are also at risk and are dying from skin cancer. There is a need to implement effective strategies to reduce the fatalities associated with all kinds of skin cancers." "We need to do more to ensure we are stopping the progression of this disease as early as possible to save lives." SOURCE EADV Congress

Study in healthy volunteers shows single dose of afamelanotide reduces erythema caused by ultraviolet radiationMELBOURNE, Australia, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Results released today from a clinical study have shown that the drug afamelanotide can reduce critical skin damage caused by ultraviolet (UV) radiation, a leading factor in skin cancer and photoaging. The CUV151 study, conducted by Australian company CLINUVEL, treated nine fair-skinned volunteers with the photoprotective drug afamelanotide and showed that treatment could significantly reduce artificially provoked “sunburn damage” after just six days. “Frequent and intense sunburn is recognised as a primary risk factor for skin cancer, with fair skinned individuals – known as Fitzpatrick phototypes I-III – at high-risk,” CLINUVEL’s Head of Clinical Operations, Dr Pilar Bilbao said. “Showing that we can objectively reduce erythema, sunburn DNA damage, under controlled clinical conditions after a single dose of afamelanotide provides our team with valuable data on how this drug, and other similar molecules, can reduce the burden of UV-induced damage. Further clinical work is ongoing to assess the properties and influence of afamelanotide on other parts of cellular DNA,” Dr Bilbao said. Between five and six million cases of skin cancers are diagnosed in the USA alone every year, with UV exposure and fair skin proven to increase an individual’s lifetime risk.1 An estimated US$8.1 billion is spent annually treating skin cancers in the USA, suggesting more effective preventative measures are required. CLINUVEL is evaluating afamelanotide as a photoprotective and DNA repair treatment for individuals at highest-risk of UV and light damage, focusing first on patients with the DNA repair disorder xeroderma pigmentosum (XP). The CUV151 study followed a parallel protocol to clinical trials for XP patients, assessing biomarkers of UV-induced skin damage in healthy volunteers following provocation of UV damage before and after afamelanotide treatment. The first results showed a statistically significant decrease in UV-erythema dose response, the redness indicative of first DNA damage, which was provoked by incremental doses of UV light (p=0.018). An increase in the minimal erythemal dose – a measure of intensity of UV light to provoke sunburn – was also found. Earlier results in XP patients showed that afamelanotide could reduce UV-induced DNA damage, with analyses of skin samples (biopsies) from CUV151 ongoing to assess DNA damage in the healthy volunteers. “Today’s results build upon the decades of research CLINUVEL has conducted into the use of afamelanotide to protect skin from light, with the first evidence that a single dose of the drug has a photoprotective effect in healthy volunteers. These data add to our regulatory dossier for XP while further developing our specialised healthcare products for wider populations at highest risk of UV-induced damage and skin cancer,” Dr Bilbao said. Final results from the CUV151 study and further results from CLINUVEL’s DNA Repair Program are expected later in 2023. Media enquiries: Monsoon Communications, Mr Rudi Michelson, +61 411 402 737, rudim@monsoon.com.au Note to media: CLINUVEL has released further investor and technical releases on results from the CUV151 study. For more details, go to www.clinuvel.com. 1 Skin & Cancer Foundation – Skin Cancer Facts & Statistics, https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/; American Academy of Dermatology – Skin Cancer https://www.aad.org/media/stats-skin-cancer. About Afamelanotide Afamelanotide belongs to the family of melanocortins, hormones and their analogues, which are recognised to activate human pigmentation, reduce oxidative damage, inflammation and swelling, and optimise the response of skin cells to UV-induced damage. CLINUVEL is already marketing a controlled-release formulation of afamelanotide – known as SCENESSE® – as the world’s first photoprotective drug for the rare disorder erythropoietic protoporphyria (EPP). Further results from the Company’s DNA repair program are expected later in 2023. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL 1: CLVLY; BÖRSE FRANKFURT-DAX: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. SCENESSE®, PRÉNUMBRA®, NEURACTHEL®, and CYACÊLLE® are registered trademarks of CLINUVEL. Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries https://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. 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