“XP patients are known as ‘children of the moon’ due to their need to avoid any light and sun exposure or risk severe, aggressive skin cancers from an early age,” CLINUVEL’s expert genomic scientist, Dr
Xeroderma pigmentosum affects patients’ ability to repair DNA skin damage following exposure to light, particularly ultraviolet (UV) radiation. The disorder – which affects an estimated one in a million individuals – leads to a 1,000-fold increase in the risk of skin cancer and, tragically, a life expectancy of around 30 years.
Australian biopharmaceutical company CLINUVEL started clinical trials of afamelanotide in XP patients in 2020, aiming to assess whether treatment with the drug could safely reduce the number of photoproducts – breakages in the DNA helix known as CPDs – as well as showing improvement in other markers of skin damage.
Results from the first three XP patients treated showed a reduction in CPDs, particularly at deeper levels of the skin, as well as a decrease in sunburn (under controlled laboratory conditions). Key markers such as p53 and γH2AX also showed response to the drug.
The expert physicians caring for the XP patients assessed that afamelanotide treatment provided effective systemic photoprotection and was well tolerated.
“These results are exciting as the findings may be translated to wider populations who are at higher risk of skin cancer due to DNA damage, such as those who are immunosuppressed or with fair skin, blue eyes and fair hair,”
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.
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Note to media: CLINUVEL has released further investor and technical releases on results from the CUV156 study. For more details, go to www.clinuvel.com.
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CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in
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