Patient recruitment in Biofrontera's international phase III study with BF-200 ALA completed
Biofrontera AG announced that patient enrolment in the second pivotal phase III study with BF-200 ALA has been completed. The clinical trial compares the efficacy of Biofrontera's leading development product BF-200 ALA to placebo in patients with actinic keratosis. Participants in the study are 27 study centers in Germany, Austria, France and Switzerland. The responsible CRO for the study is Accovion GmbH in Eschborn, Germany, with PD Dr. med. Thomas Dirschka, Wuppertal, serving as principal investigator.
According to the study protocol 616 patients were to be enrolled, with a calculated drop-out rate of 20%. Of these patients, 264 patients each should receive BF-200 ALA or the comparator Metvix®, and 88 patients should be treated with a placebo gel. Due to a significantly lower drop-out rate patient enrolment could already be completed after the screening of 600 patients. Of these 600 patients, 572 have been treated, and as of today 215 patients have already passed the entire treatment and post-treatment observation period. The drop-outs were mostly related to the screening of patients who were not concordant with the inclusion criteria. Serious side-effects have not occurred.
BF-200 ALA is a gel applied in the photodynamic therapy of actinic keratosis, a cancerous skin lesion very frequently occurring in sun-exposed skin regions, particularly in the elderly population. The gel combines Biofrontera's proprietary nanoemulsion BF-200 with the active ingredient 5-aminolevulinic acid (ALA). In photodynamic therapy the application of the gel is followed by a brief illumination with red light.
In the clinical study the PDT is performed once, followed by an examination of the patients 3 months later. If remainders of the lesions are still present, they are treated again. In this case the final examination of the patients will again occur three months later. This treatment regimen is followed by a 12-month post-treatment observation period. Since the last patient will have completed both, the treatment and 3-month post-treatment observation period in summer, Biofrontera expects the results of the study before the end of 2009.
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