Phase III results show 80% lesion clearance in sun-induced skin cancer

7 February 2017

Germany-based skin cancer specialist Biofrontera (FSE: B8F) has reported positive preliminary results for the primary endpoint of its Phase III clinical trial evaluating the safety and efficacy of Ameluz (aminolevulinic acid hydrochloride) in combination with daylight photodynamic therapy (PDT).

The company’s share price rose by nearly 4% to 4 euros on Tuesday morning after Monday evening’s announcement that the study had met its primary endpoint by demonstrating that this combination was not-inferior to the standard of care Metvix (methyl aminolevulinate) and daylight PDT for mild to moderate actinic keratosis (AK), a superficial early skin cancer.

These results on Ameluz, which has already been approved in the USA and European Union (EU), will be used for the filing of an EU label extension which Biofrontera plans to submit in the second quarter of this year.

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