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 age in Germany has actinic keratosis, the incidence doubles every 10 years. We will develop the 10 % formulation further for the treatment of this unusually frequent disease and intend to bring it to registration by 2009," commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG.
About Biofrontera AG Biofrontera AG is specialized in the development of pharmaceutical products in the area of dermatology. The company is characterized by a broad, relatively close to the market product portfolio and a solid liquidity. Biofrontera is listed in the regulated market of the Düsseldorf stock exchange under the symbol B8F and the ISIN number DE0006046113. http://www.biofrontera.com/
This press release contains forward-looking statements based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the assumptions expressed or implied in this press release to be faulty. Given these risks, uncertainties and other factors, recipients of this document are cautioned not to place undue reliance on the forward-looking statements. Biofrontera AG disclaims any obligation to update these forward-looking statements to reflect future events or developments.
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