BioLineRx announces receipt 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 recently completed open-label, single-arm trial was 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 almost all the patients (96.7%) the lesion sloughed 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.
In addition, most of the investigators and patients who participated in the trial reported that they were very satisfied with the cosmetic outcome of the treatment. 94.6% of the investigators and 84% of the patients stated that the results were good or excellent 180 days following treatment.
Histological examination of the lesions showed that BL-5010 enables preservation of the histological structure of the treated lesion.
Dr. Kinneret Savitsky, BioLineRx CEO, said “We are happy with the positive results of the clinical trial, which fulfill our expectations regarding BL-5010’s efficacy and safety. BL-5010 represents a novel method for removing skin lesions without surgery, anesthesia and without significant adverse effects. We are currently looking at our next steps from a regulatory, clinical and business perspective. In addition, we continue to invest significant efforts in developing the rest of our products while seeking additional innovative projects to expand the Company’s pipeline.”
Date: January 3, 2011
Source: BioLineRx Ltd.
Filed Under: Drug Discovery