19th Nov 2015 09:10
LONDON (Alliance News) - Biofrontera AG said Thursday that the last patient in its ongoing phase III trial for basal cell carcinoma has had its final clinical visit, concluding the clinical phase of the study.
The company expects preliminary results of the main clinical endpoints of the study before the end of the year, and the final report by the end of the first quarter of 2016. Data from the trial will be part of the company's efforts to obtain approval for its product Ameluz in the treatment of basal cell carcinoma, a form of skin cancer.
The study will have a five-year follow up period.
"The data from this phase III study will allow us to obtain approval for BCC treatment with Ameluz in Europe, which technically is a variation of the existing centralized approval. The agency's decision on such a variation takes three months from the application plus the time required to answer questions of the agency. We anticipate the approval in the summer of 2016 and subsequently envision a significantly larger market potential for Ameluz," said Chief Executive Officer Hermann Luebbert in a statement.
Shares in Biofrontera were untraded Thursday. It last closed at 155.00 pence.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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