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Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy,of BF-200 ALA In Actinic Keratosis

LEVERKUSEN, Germany - Biofrontera AG (DSE: B8F) announces today that it has received very positive results in the dose finding part of its phase IIb/III clinical trial started in autumn 2006. BF-200 ALA, a gel that combines the active substance 5-aminolevulinic acid (ALA) with the nanoemulsion BF-200, was strongly and significantly superior to placebo in the treatment of actinic keratosis. BF-200 ALA is used in photodynamic therapy, which eliminates tumor tissue through a combination of an active substance and the irradiation with red light.

The placebo-controlled, randomized and double-blind study was conducted in 13 clinical centers in Germany under the medical direction of Prof. Dr. Rolf-Markus Szeimies, University Clinics of Regensburg. To verify the efficacy of the compound, 105 patients were treated once by photodynamic therapy with one of three different ALA concentrations or placebo. Primary endpoint of the clinical trial was the percentage of the complete remission of actinic lesions. Since strong pain often occurs during photodynamic therapy with competitor products, the appearance of pain during the irradiation after BF-200 ALA application was also monitored.

When patients were evaluated 12 weeks after a single treatment with BF-200 ALA, at least 60-70 % of the treated lesions were completely cured, depending on the weighting of the clinical centers and the area of the head. Relevant side effects did not occur during the study, the cosmetic results were excellent. Only 6 % of the patients complained about strong pain. The 10% dose of the active compound ALA was superior to the other doses tested. Consequently, Biofrontera will conduct additional studies to verify the safety and efficacy of this concentration in preparation for its registration.

"This result impressively demonstrates the great potential of our development candidate BF-200 ALA. Every other person above 60 years of
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