BioLineRx Ltd. has announced the publication of positive results from the Phase 1/2 clinical trial of BL-5010, a novel formulation for the non-surgical removal of skin lesions. The successful trial results were published online in the prestigious British Journal of Dermatology.
Dr. Kinneret Savitsky, BioLineRx CEO said: "We are proud to have the results of the BL-5010 clinical trial published in the British Journal of Dermatology. This is one of our most promising clinical candidates, as reflected by the out-licensing agreement we recently signed with Omega Pharma, and by the excellent results of the clinical trial. The results not only show that BL-5010 is highly effective in removing seborrheic keratosis, but also that 94.6% of the investigators and 84% of the patients who participated in the trial reported that they were very satisfied with the cosmetic outcome of the treatment and that the results were good or excellent 180 days following treatment. BL-5010 offers a novel method for removing skin lesions without surgery, anesthesia or significant adverse effects, and we look forward to seeing this innovative product on the market."
The publication details the results, which were previously disclosed by BioLineRx in December 2010, of an open-label, single-arm trial conducted in 60 patients with seborrheic keratosis in Germany and the Netherlands. The objectives of the study were to determine the safety and efficacy of BL-5010 in completely removing the lesion and to assess the cosmetic outcome of the novel treatment. The study also aimed at evaluating BL-5010’s feasibility in preserving the lesions for subsequent histological examination.
The results of the trial show that for nearly all patients (96.7%), the lesion fell off within 30 days of a single application of BL-5010. Furthermore, the results show that BL-5010 has a good safety profile, as no persistent irreversible adverse effects were observed at the treated site. Histological examination of the lesions showed that BL-5010 enables preservation of the histological structure of the treated lesion.
In December 2014, BL-5010 was out-licensed to Omega Pharma, one of the largest OTC healthcare companies in Europe, for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx retains the rights to BL-5010 in the U.S. and the rest of the world.