Clinuvel Pharmaceuticals had obtained positive results from an experimental trial evaluating the photoprotective effect of Afamelanotide in 16 patients.
The objective of this pilot Phase II trial was to determine the effect of a single 16mg dose of Afamelanotide on the quality of life and phototoxicity in patients undergoing systemic photodynamic therapy (PDT), a treatment for certain gastro-intestinal cancers, in four clinics in France.
In total, 16 Caucasian patients were included, nine patients were administered Afamelanotide and seven patients placebo treatment as a subcutaneous implant at the same time as the photosensitising agent Photofrin.
Post-operative analysis at seven and 12 days revealed a positive trend to tolerate ambient light at standardised exposure by seven out of nine patients (77%) receiving Afamelanotide. In patients on active drug, a significant improvement in quality of life assessment was demonstrated at 60 days of treatment (p=0.02). Clinical observations from all physicians and reports from patients supported and encouraged further use of Afamelanotide in PDT cancer trials. No significant drug-related adverse events were reported.
In PDT, a photosensitising drug (Photofrin) 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, however, patients must avoid sunlight and artificial lights or risk phototoxic reactions: 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.
Hank Agersborg, chief scientific officer of Clinuvel, said: “These results are meaningful as they statistically confirmed the benefits of the adjunctive use of Afamelanotide in a small group of oncology and terminally ill patients. In the next few weeks we will decide on a further Phase III trial in PDT. The particular choice for Afamelanotide as an adjuvant photoprotective drug in gastro-intestinal cancer stems from the common biochemical pathways seen in both PDT and erythropoietic protoporphyria (EPP), a disease in which we are using Afamelanotide in parallel advanced Phase III trials.
“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.”