Excellent Phase III results of Biofrontera's BF-200 ALA presented at dermatology congress
Leverkusen, Germany - Biofrontera AG (DSE: B8F) announced, that the results of the phase III study of its drug candidate BF-200 ALA will today be presented at the 45th expert conference of the German Society for Dermatology (DDG) in Dresden, Germany, by the principal clinical investigator of the study, Professor Dr. med. Rolf-Markus Szeimies (University Regensburg). BF-200 ALA is applied in combination with a red light irradiation and succeeded to entirely remove actinic keratosis lesions in almost all patients. Actinic keratoses are superficial skin tumors which are removed by BF-200 ALA in a one-time treatment without scar formation. The clinical study emphasized that the light source chosen for the irradiation had a profound influence on the efficacy of the treatment and on temporarily occurring side effects.
In the pivotal clinical phase III study 122 patients with actinic keratosis were treated by photodynamic therapy (PDT) with either BF-200 ALA or a placebo gel. The enrolled patients had 4 to 8 distinct actinic lesions in the treatment area, which were treated once with BF-200 ALA PDT. If residual lesions remained, the treatment was repeated after 3 months. For the red-light irradiation, physicians participating in the clinical trial were given the choice of several light sources routinely used in photodynamic therapy.
Surprisingly, the analysis of the clinical data clearly demonstrated that different PDT lamps have a profound effect on efficacy and side effects of the therapy. It was observed that 99% of all lesions were removed in patients irradiated with the Aktilight® CL 128. With this light source, complete removal of all lesions along with a flawless cosmetic result was achieved in more than 96% of the patients. Alongside with this impressive treatment success temporary skin irritations or pain during the irradiation occurred in 72% of the patients. In contrast, after irradiation with the Photodyn® 750 light source a complete removal was achieved in 71% of all lesions and 53% of the patients were entirely freed of all their actinic keratoses. Using this light source did not lead to skin irritations and only 22% of the patients reported painful sensation during the irradiation.
"We are very pleased that the phase III trial with BF-200 ALA showed such impressive and interesting results, which are now presented at a renowned dermatological congress with over 1,500 participants. The strong light source dependence of the treatment success and the side effects enable the dermatologist to design the optimal treatment regime for the individual patient," commented Professor Hermann Lübbert, CEO of Biofrontera AG.
BF-200 ALA gel is a drug for the treatment of actinic keratosis, currently tested in phase III clinical trials. Already in December Biofrontera published preliminary results of the study which documented the excellent efficacy of BF-200 ALA in the treatment of actinic keratosis (ad-hoc news of 19 December 2008).
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. Biofrontera is listed in the regulated market of the Düsseldorf stock exchange under the symbol B8F and the ISIN number DE0006046113. www.biofrontera.comhttp://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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Posted: April 2009