BioLineRx has announced that it has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to commence a pivotal, CE Mark registration trial for BL-5010P, for the non-surgical removal of benign skin lesions.
BL-5010P is a disposable, pen-like applicator containing BL-5010, a novel aqueous solution, which is an alternative to painful, invasive and expensive removal treatments such as cryotherapy, laser treatment or surgery.
The primary objective of the single-arm, open-label, pivotal bridging study is to assess the efficacy of a single application of BL-5010 in the removal of seborrheic keratosis (SK) lesions.
BioLineRx expects to enroll up to 20 patients at up to three leading sites in Germany. The primary study endpoint is the complete lesion removal rate at Days 30, 90 and 180 after treatment. Secondary objectives include safety and tolerability, assessment of cosmetic outcomes by both patients and investigators, and the ability to preserve the treated SK lesions for histopathological diagnosis, which is a key differentiator for BL-5010P. The upcoming pivotal study will be performed using the final product, known as BL-5010P, which comprises both the novel formulation and the unique, applicator.
"We are very pleased to have received approval from the German authorities to commence a pivotal bridging study for BL-5010P. This important approval reaffirms that BL-5010P will be developed and regulated in Europe as a medical device, meaning that success in this study should enable us to apply for CE Marking immediately, and potentially introduce BL-5010P to the European market in 2015. We also expect to file for approval in other selected markets, including Australia, immediately following receipt of the CE Mark," stated Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx.
"The novel BL-5010 formulation has already demonstrated outstanding results in the treatment of benign skin lesions in a 60-patient clinical trial conducted in Germany and the Netherlands, where a single application achieved lesion removal in 97% of cases. Future development plans include expansion to additional therapeutic indications, including actinic keratosis, a pre-cancerous skin condition, viral warts and skin tags. In parallel to completing preparations for the study, we continue to hold discussions with potential partners," concluded Dr. Savitsky.