Clinuvel Pharmaceuticals has provided an update on the use of its drug SCENESSE (afamelanotide 16mg) in the first xeroderma pigmentosum (XP-C) patient receiving treatment as part of its DNA Repair Program.
The company said the first male XP-C patient started SCENESSE treatment in September under a Special Access Program and has been closely monitored by the expert clinical centre responsible for medical care.
It said regular clinical observations have been made over the 42-day treatment period to assess the patient’s health, including the response to overall afamelanotide treatment.
XP patients exhibit extreme deficiency in repair of UV-provoked damage to the DNA helix within the nucleus of skin cells. If left unrepaired, damaged DNA replicates and significantly increases the risk of skin cancers, including melanoma in these patients.
"The patient tolerated the melanocortin drug well and no drug related adverse events have been reported. Specific attention has been given to the consequences of ultraviolet (UV) exposure, pigmentation, and overall status of the patient’s skin," said the company.
"XP patients are known to exhibit poikiloderma (degeneration and disintegration of the skin) and are prone to frequent bleeding from chronic wounds. At the end of the 42 days, the integrity of the skin of the XP-C patient has shown to be unaffected by afamelanotide."
“We are delighted with the consistent safety reports from the XP-C patient receiving systemic treatment with afamelanotide,” said Clinuvel’s clinical Operations Manager, Dr Pilar Bilbao said. “This positive observation and clinical feedback from the treating physician form the basis for progressing the planned XP study, CUV150.”