Ad hoc: Interim report about clinical trial of BF-200 ALA in actinic keratosis
LEVERKUSEN, Germany, 30 April 2007 - Biofrontera AG announced that an interim report regarding the clinical study of BF-200 ALA in actinic keratosis was received today from an independent review committee. The objectives of the study are to investigate the efficacy and safety of several doses of BF-200 ALA in photodynamic therapy. The comments received today refer to the clinical results eight weeks after treatment. An additional report about the results after twelve weeks will follow.
The interim committee reported that no side effect justifying concerns about the safety of this dose were observed in any dose group. On the basis of the available data, the therapy was found to be safe for all doses tested.
In spite of the limited patient number, different doses gave rise to clear differences in efficacy. However, the results of the different doses were not yet disclosed. The committee announced this disclosure once it has received and analyzed the clinical results 12 weeks after treatment. Biofrontera expects this second report within few weeks.
To optimize the statistical study design, the committee has proposed to continue the phase III part of the study separately. This will enable the complete analysis of the 12-week data. On this basis, Biofrontera intends to continue the further development of the 10 % dose, provided this dose selection is supported by the 12-week data.
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Contact: Anke zur Mühlen Biofrontera AG Tel.: +49 (0214) 87 63 222 Fax.: +49 (0214) 87 63 290 e-mail: email@example.com
Posted: April 2007