BioLine has announced the initiation of phase I/II clinical trial aimed at assessing the safety and efficacy of BL-5010, a novel formulation for the non surgical removal of skin lesions.
The open-label, single arm trial will be conducted in 60 patients with seborrheic keratosis in Germany and the Netherlands. The aim of the study is to determine the safety and tolerability of the BL-5010 formulation, and to assess its efficacy in completely removing the lesion.
Further, it will also assess BL-5010’s efficacy in preserving the cellular structure of the lesion for subsequent histological examination. The study is scheduled to start in June, 2009. Interim results from the first 25 patients are expected in the fourth quarter of 2009.
Morris Laster, CEO of BioLineRx, said: “BL-5010 is an exciting product in development that may offer a fast, safe and painless way to eliminate skin lesions. We look forward to accelerating development of this novel formulation.”