BioLineRx (BLRX) gained approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to start a pivotal, CE Mark (Conformite Europeenne) registration trial for BL-5010P for novel skin lesion treatment. The single-arm, open-label, pivotal bridging study is expected to begin in the first half of 2014.
We note that BL-5010P is a pen-like applicator containing the BL-5010 solution.
BioLineRx expects to enroll up to 20 patients in this study. The primary endpoint is to assess the efficacy of a single application of BL-5010 in the removal of seborrheic keratosis (SK) lesions. The complete lesion removal rate will be assessed at days – 30, 90 and 180 after treatment.
Safety, tolerability and assessment of cosmetic outcomes by both patients and investigators constitute the secondary endpoints of the study. It will also assess the ability to preserve the treated SK lesions for histopathological diagnosis. BioLineRx expects results from this study in the second half of 2014.
The successful completion of the study will enable the company to apply for CE Mark registration of the candidate. The CE mark enables the free movement of products inside Europe. BioLineRx expects the candidate to be approved in Europe by 2015.
BL-5010 demonstrated good results in a phase I/II pilot study in Dec 2010. This study showed that 97% of the patients enrolled (n=60) experienced removal of the target lesion within a month.
We note that in Nov 2007, BioLineRx entered into a worldwide exclusive license agreement with Innovative Pharmaceutical Concepts, Ltd. for BL-5010. BioLineRx has global rights to develop, market and sell BL-5010.
BioLineRx carries a Zacks Rank #3 (Hold). Some better-ranked players in the pharma industry include Actelion Ltd. (ALIOF), Endocyte, Inc. (ECYT) and Lannett Co. Inc. (LCI). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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