Biofrontera AG (DE) - Ad hoc: Phase III data of BF-200 ALA demonstrate superiority against Metvix
Leverkusen, Germany, 02 December 2009 - Biofrontera (DSE: B8F) announces that the company has today been informed about preliminary results of the final pivotal phase III trial with its leading drug candidate BF-200 ALA.
The results show with high statistical significance that 78% of the patients were totally cleared from all actinic keratoses after treatment with BF-200 ALA, while comparator Metvix® showed total clearance in only 64% of the patients. A total clearance rate of 17% was measured in the placebo group. In spite of the higher efficacy of BF-200 ALA the incidence of side-effects was not increased compared to Metvix®.
The first, already completed phase III trial has shown that the light source has an immense effect on the efficacy of the treatment. Several different light sources were also tested in the current study, but the individual results have not been analyzed thus far. Therefore, the detailed analysis is expected to show substantially better clearance rates with the best light source.
"Results were obtained earlier than expected due to the outstanding data management of the responsible clinical research organization Accovion GmbH. The statistically significant superiority of BF-200 ALA over Metvix® exceeds the original goals of the study," commented Prof. Hermann Lübbert, Biofrontera's CEO.
In the treatment, superficial tumors were covered with one of the two drugs, followed by an illumination with red light for a few minutes. The treatment was repeated in those cases where residual keratoses were still present three months after the treatment. Treatment success was monitored another three months later.
570 patients were included in this phase III trial performed with photodynamic therapy of actinic keratoses. The study, which was ongoing since 2008, compared the efficacy of BF-200 ALA with that of Metvix®. Additionally placebo-controlled, this comparator study is the final pivotal trial required for the Marketing Authorization Application (MAA) of BF-200 ALA, which will be filed after obtaining the last stability data in the next summer.
Telephone conference On Thursday, December 3, at 10 a.m. CET Biofrontera will hold a telephone conference, in which the Biofrontera management will inform about the results of the phase III trial in more detail and answer questions.
The dial-in numbers for the telephone conference will be: +49 (0)69 9897 2623 (from Europe) or +44(0)20 7138 0844 (from UK).
Please dial in 10 minutes before the conference starts to warrant a timely beginning.
About BF-200 ALA BF-200 ALA is a gel applied within photodynamic therapy for the treatment of actinic keratosis, a superficial, malignant skin cancer. The gel combines Biofrontera's proprietary nanoemulsion BF-200 with the active ingredient 5-aminolevulinic acid (ALA). The photodynamic therapy consists of a one-time application of BF-200 ALA, followed with some time-delay by a brief illumination with red light.
Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen, Germany ISIN: DE0006046113, WKN: 604611
Contact: Anke zur Mühlen Biofrontera AG Tel.: +49 (0214) 87 63 222 Fax.: +49 (0214) 87 63 290 E-mail: email@example.com
Posted: December 2009