Date: 2015-06-01
Type of information: Publication of results in a medical journal
phase: 1-2
Announcement: publication of results in the British Journal of Dermatology
Company: BioLineRx (Israel)
Product: BL-5010P
Action
mechanism: BL-5010 is a novel aqueous formulation composed of approved components for the non-surgical removal of benign skin lesions such as seborrheic keratosis. BL-5010 offers an alternative to painful, invasive and expensive removal treatments including surgery, cryotherapy or laser treatment. Because the treatment is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia or bandaging. The formulation is applied topically to the lesion for a few seconds and causes the lesion to gradually dry out and fall off within one to four weeks. BL-5010P is a disposable, non-invasive, pen-like applicator containing the BL-5010 solution. Both BL-5010 and BL-5010P have received confirmation in Europe for the regulatory pathway classification as a medical device Class IIa. 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.
Disease: seborrheic keratosis
actinic keratosis
Therapeutic area: Dermatological diseases
Country: Germany, The Netherlands
Trial
details: 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 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, state-of-the-art applicator.
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.
Latest
news: * On June 1, 2015, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, 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 British Journal of Dermatology. 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. * On January 21, 2014, BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, 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.
* On July 29, 2013, BioLineRx has announced 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.
A Phase 1/2 pilot study, performed on 60 patients with SK, demonstrated that a single, topical application of BL-5010 was effective in 96.7% of cases for removal of the target lesion within 30 days. In addition, the treatment was well-tolerated and no persistent irreversible adverse effects were observed at the treated site. Furthermore, cosmetic outcomes were highly rated by both patients and investigators. BL-5010 was invented by Prof. Pinchas Burstein and is being developed under a worldwide exclusive license from Innovative Pharmaceutical Concepts, Ltd. During the course of developing BL-5010, Prof. Burstein accumulated additional data on the product showing that BL-5010 can be relevant for other types of skin lesions as well.
