Clinuvel doses first patient with DNA repair therapy

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Australian company Clinuvel (ASX:CUV) has announced it has dosed the first patient in its SCENESSE DNA Repair Program.

The company announced a patient suffering from xeroderma pigmentosum (XP), a disease characterised by an inborn insufficiency to repair DNA damaged by sun exposure, has been treated by SCENESSE (afamelanotide).

The therapy belongs to a group of hormones that have been shown to reduce UV-induced damage to DNA (photoproducts) and assist in DNA regeneration.

Clinuvel said it is running a staged clinical program to test the ability of SCENESSE to 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," said the company in a statement.

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, said the company.

It said an estimated 1 in 450,000 individuals in Europe suffers from XP.

SCENESSE has been administered for the first time to a patient diagnosed with XP under a Special Access Program, whereby the safety will be evaluated over six weeks of treatment.

The company said following confirmation of safety, it will conduct two further studies as part of the DNA Repair Program.

Both studies – an open-label phase two study involving six XP-C patients (CUV150) and a control study enrolling ten 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 fairskinned individuals at risk of developing skin cancers,” said Clinuvel’s clinical operations manager, Dr Pilar Bilbao. “The next 12 months will be exciting for many patients, their families, the clinical experts and our own teams.”