BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it has filed the necessary regulatory submissions to commence a pivotal, CE-Mark registration trial for BL-5010P - for the non-surgical removal of skin lesions - with the German Federal Institute for Drugs and Medical Devices (BfArM), as well as with the relevant ethics committees.
The pivotal study is a single-arm, open-label, bridging study of BL-5010P, a pen-like applicator containing BL-5010, a novel aqueous solution. The primary objective of the study is to assess the efficacy of a single application of BL-5010P for the removal of seborrheic keratosis (SK) lesions. Secondary objectives include safety and tolerability assessments of the cosmetic outcomes as evaluated by both patients and investigators, and the ability to preserve the treated SK lesions for histopathological diagnosis. Up to 20 patients are expected to be enrolled at three leading sites in Germany. BioLineRx is collaborating with the Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Project Group Translational Medicine & Pharmacology TMP (“Fraunhofer Institute”) regarding the operational and regulatory aspects of the trial.
“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,” stated Kinneret Savitsky, Ph.D., Chief Executive Officer of BioLineRx. “In that trial, a single application of BL-5010 achieved lesion removal in 96.7% of the cases. Now, we intend to perform a pivotal bridging study on the final product, known as BL-5010P, which comprises both the novel formulation and a unique, state-of-the-art, pen-like applicator. Success in this study should enable us to immediately apply for CE-Mark registration of the product, which could be ready for the European market by the second half of 2014. Future development plans include expansion to additional therapeutic indications, including actinic keratosis, a pre-cancerous skin condition. In parallel to completing preparations for the study, we are also continuing to hold discussions with potential partners,” concluded Dr. Savitsky.
“We were encouraged by the promising data of BioLineRx's novel formulation for the non-surgical removal of skin lesions. The Fraunhofer Institute is delighted to enter into this close collaboration with BioLineRx, as our Division for Clinical Research maintains responsibility for all regulatory processes at the German sites,” stated Dr. Frank Behrens, Head of Clinical Research at Fraunhofer-IME-TMP in Frankfurt/Main.