) 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
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
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
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
Lannett Co. Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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