2nd Oct 2014 06:53
LONDON (Alliance News) - Biofrontera AG Thursday said it has completed the clinical programme for US approval of its Ameluz product, with trials confirming the efficacy and safety of the treatment.
The biopharmaceutical company said the preliminary results from the ongoing trial of its Ameluz skin cancer drug confirmed its positive expectations.
More than 90% of the patients taking part in the Phase 3 trial were fully cleared of all actinic keratoses after a maximum of two treatments with the drug. Actinic keratoses are skin lesions caused by damage from ultraviolet rays.
In addition, only 38% of the patients required the second treatment, Biofrontera said.
Along with the phase 3 trial, Biofrontera said the US Food and Drug Administration has suggested two phase 1 studies in the clinical programme for the approval of Ameluz and BF-Rhodoled.
By Sam Unsted; [email protected]; @SamUAtAlliance
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