First patient dosed in SCENESSE DNA Repair Program

MELBOURNE, Australia, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Xeroderma pigmentosum (XP) patient receives SCENESSE treatment

Note to editors: CLINUVEL is releasing in-depth infographics and a video explaining the mechanisms of action in XP and the overall DNA repair process. For updates, follow:
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In the search for a preventative treatment of skin cancers, including melanoma, it is imperative to understand and treat DNA damage caused by ultraviolet (UV) radiation. Following the treatment of a patient suffering from xeroderma pigmentosum (XP), a disease characterised by an inborn insufficiency to repair DNA damaged by sun exposure, Australian based CLINUVEL PHARMACEUTICALS is the first company worldwide to use a systemic therapy to repair DNA.

CLINUVEL’s drug SCENESSE (afamelanotide 16mg) belongs to a group of hormones which have been shown to reduce UV-induced damage to DNA (photoproducts) and assist in DNA regeneration.¹ The Company is running a staged clinical program to confirm the ability of SCENESSE to repair the DNA in skin cells, focusing initially on XP.

SCENESSE IN XERODERMA PIGMENTOSUM
XP is a genetic disease which has served as a human model for studying the insufficiency of human DNA repair. Patients develop frequent skin cancers from an early age – most experience their first malignancy before adolescence – and must avoid all forms of UV exposure. The disease has a high mortality rate, with a median life expectancy of thirty years. XP treatment is limited to management of symptoms, in particular regular surgery to remove cancerous lesions. An estimated 1 in 450,000 individuals in Europe suffer from XP.

Today CLINUVEL announced that SCENESSE has been administered for the first time to a patient diagnosed with XP under a Special Access Program, whereby the patient’s safety will be evaluated over six weeks of treatment. Following confirmation of safety of the drug product in this patient, CLINUVEL will conduct two further studies as part of the DNA Repair Program. Both studies – an open-label Phase II study involving six XP-C patients (CUV150) and a control study enrolling 10 healthy volunteers (CUV151) – will evaluate the impact of treatment with SCENESSE on DNA damage and restoration.