CLINUVEL (ASX:CUV) has administered SCENESSE for the first time to a patient diagnosed with xeroderma pigmentosum (XP) under a Special Access Programme, whereby the patient’s safety will be evaluated over six weeks of treatment.
CLINUVEL’s Clinical Operations Manager, Dr Pilar Bilbaom said the company is searching 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 XP, a disease characterised by an inborn insufficiency to repair DNA damaged by sun exposure, Australian based CLINUVEL claims to be 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.The company is running a staged clinical program to confirm the ability of SCENESSEto repair the DNA in skin cells, focusing initially on XP.
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.
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.
We seek to provide meaningful benefit to XP patients, and these results will serve a wider population of fair- skinned individuals at risk of developing skin cancers,” CLINUVEL’s Clinical Operations Manager, Dr Pilar Bilbao said.
“The next 12 months will be exciting for many patients, their families, the clinical experts and our own teams.”