Initially, clinical results for three different doses of the active ingredient 5-aminolevulinic acid (ALA) and placebo are compared. Following the treatment and two-month observation of 80 patients enrolled in the first part of the study, independent experts will perform an interim analysis to select the optimal dose of the drug. All 80 patients have already completed the treatment and Biofrontera expects the results of the interim analysis in the first quarter of 2007. Subsequently, efficacy and safety of BF-200 ALA will be verified with additional 160 patients.
The randomized, placebo-controlled clinical Phase IIb/III trial is conducted in 13 centers in Germany. In parallel to the ongoing trial, a second Phase III trial is currently prepared with approximately 200 patients to compare BF-200 ALA with a standard therapy. Excellent clinical efficacy of combinations of ALA with nanoemulsions has already been demonstrated for superficial basal cell carcinoma in two earlier Phase II trials, where a single treatment eliminated more than 80% of the tumors.