Clinuvel gets positive results for afamelanotide

A pilot phase II trial has demonstrated that Clinuvel's flagship photoprotective drug, afamelanotide, has improved levels of light tolerance in cancer patients undergoing systemic photodynamic therapy (PDT).

In PDT, a photosensitising drug is administered intravenously to enhance and accelerate tumour treatment by laser illumination. In patients with advanced stage bile duct cancer, the treatment is reported to extend average life expectancy from 98 to 498 days.

For up to 90 days following treatment, patients must avoid sunlight and artificial lights or risk phototoxic reactions, such as intense pain and second degree burns. Clinuvel is evaluating the use of afamelanotide in a group of light intolerant patients in order to obtain registration for the novel drug.

In the study, which was carried out in France, nine of 16 patients undergoing PDT were given a single 16 mg dose of afamelanotide, with the other seven given a placebo treatment.

Analysis at seven and 12 days showed that seven out of the nine patients treated with afamelanotide were able to tolerate ambient light exposure. These patients also had significantly improved quality of life 60 days after the treatment.

No significant drug-related side effects were reported.

This pilot trial will contribute to registration for afamelanotide for treatment of erythropoietic protoporphyria (EPP), a disease that also results in photosensitivity. The biochemical pathways in EPP resemble those at work in PDT, so if the drug is effective in treating photosensitivity resulting from PDT, the hope is it will also aid in treating the photosensitivity from EPP.

“Today’s results are of particular relevance because we have learned from regulatory agencies that data from PDT studies may be used as supporting evidence when we file for EPP registration. Therefore, the confirmation of safety and the improvement in quality of life in these light intolerant patients provides a substantial step toward the registration of afamelanotide for EPP,” Dr Agersborg said in a company statement.

Clinuvel is undertaking phase III trials of afamelanotide in Australia and Europe for (EPP) and Polymorphous Light Eruption (PLE).