Phase III positive for Clinuvel
Thursday, 22 January, 2009
Melbourne’s Clinuvel has received positive interim results in a Phase III trial of its photoprotective drug afamelonotide.
The results, from 14 Swiss patients with erythropoietic protoporphyria (EPP) or absolute sun intolerance, showed a much reduced severity in symptoms compared to placebo over 12 months.
It also showed an increased level of melanin density in the skin. The drug aims to boost production of melanin to better protect against UV light.
The 14 patients requested that they continue to receive the drug for another 12 months on compassionate grounds, a request granted by Switzerland’s regulatory agency SwissMedic.
Another 87 patients are enrolled in the trial in Europe and Australia.
Clinuvel hopes to file for the drug’s approval in Europe in the next 18 months and to begin US trials this year. The company lodged an IND application with the US FDA last Christmas.
The company is also running a Phase III trial in polymorphic light eruption, or severe sun poisoning, and Phase II trials for pre-cancerous sun spots and squamous cell carcinoma in organ transplant recipients, solar urticaria or acute anaphylactic reaction to the sun, and as a photosensitiser when used with photodynamic therapy in cancer patients.
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