Biofrontera AG (DE) - Ad hoc: Biofrontera AG: Excellent Phase III-results with BF-200 ALA[/
From the PharmaLive.com News Archive
Leverkusen, Germany, 19 December 2008
Biofrontera AG announced today that the preliminary results of the first phase III study of its BF-200 ALA-gel in the treatment of actinic keratosis have become available. In this pivotal phase III study 122 patients were treated by photodynamic therapy (PDT), which was repeated after three months in cases where lesions were not completely removed. Two thirds of the patients were treated with BF-200 ALA, one third with placebo. In 69% of the patients treated with BF-200 ALA all actinic keratoses in the area of investigation were completely removed. Only 13.5% of the patients treated with placebo displayed a complete response. Even after a single treatment lesions had completely disappeared in 47.5% of the patients in the group treated with BF-200 ALA, but only in 10% of patients treated with placebo. These results are statistically highly significant (p<0.0001). Patients without a complete response also displayed a strong improvement that was visible in a large reduction of the lesion sizes. In addition to efficacy, safety and tolerance of the treatment were investigated. Only 5% of the patients complained about strong pain during the illumination, the cosmetic result was judged as "satisfactory" by 47%, as "good" or "very good" by 49% of the patients.
Background: Biofrontera's BF-200 ALA gel combines the active ingredient ALA (5-aminolevulinic acid) with a novel nanoemulsion (BF-200). It is applied in photodynamic therapy (PDT) of actinic keratosis consisting of a combination of the gel with red light illumination. Following the application and penetration of the gel, the diseased skin is illuminated with red light for 10-20 minutes, selectively removing the tumor cells in the skin. The phase III trial described here was initiated by Biofrontera 12 months ago in eight clinical centers in Germany. It is a placebo-controlled, double-blind study in which the efficacy of the treatment is compared with that of a placebo-gel that is indistinguishable for the physician. All lesions that were still visible 12 weeks after the treatment were treated again, and the results examined 12 weeks later. The complete treatment of all actinic keratoses in 69% of the patients is an excellent result. The low placebo rate serves as an indicator for the excellent work of the participating dermatologists. In a similar study with a competing product that was published in the middle of this year, a complete response was described that was 10% lower than in this study, even though the placebo rate was slightly higher (Pariser et al., J Am Acad Dermatol, 2008). During the red light illumination patients treated with other products for PDT often experience strong pain. In the BF-200 ALA study, only 5% of the patients complained about strong pain. Antinociceptives were not required. Since several different light sources were allowed in the study the detailed analysis of the data may show it the light source has an influence on the efficacy or the pain sensation during the treatment.
Actinic keratosis Actinic keratosis is a form a skin cancer that is still restricted to the upper layers of the epidermis (the outer skin layer). These tumors result from UV-light induced lesions accumulating during the life time. They occur with strongly increasing abundance in sun-exposed skin regions in already about 50% of the male population above 50 years of age. The disease is slightly less frequent in women. After penetrating the basal membrane at the inner surface of the outer skin layer, actinic keratosis can develop into malignant squamous cell carcinoma.
Biofrontera AG Hemmelrather Weg 201, 51377 Leverkusen, Germany ISIN: DE0006046113 WKN: 604611
AI
Market Data 
Markets 
