BioLineRx (BLRX) announced that the first patient has been dosed in a phase I/II study of pipeline candidate, BL-7010.
BL-7010 is being evaluated for the treatment of celiac disease. In this double-blind, placebo-controlled, dose escalation, two-part study, the primary endpoint is the evaluation of the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. Secondary endpoint is the assessment of systemic exposure of BL-7010 in the patients. Results will be out in mid 2014. This study will be followed by an efficacy study which will start in the second half of 2014.
We note that BL-7010 is developed by BioLineRx under a worldwide exclusive license agreement with Univalor.
Apart from BL-7010, BioLineRx’s pipeline looks promising with candidates like BL-5010 (non-surgical removal of skin lesions, a pivotal CE-mark registration trial to start in early 2014); BL-1040 (preventing pathological cardiac remodelling following a myocardial infarction, currently in a pivotal CE-Mark registration trial) and BL-8040 (acute myeloid leukemia (:AML) and other hematological cancer indications, currently in a phase II study).
Earlier this week, BioLineRx announced positive initial results on BL-8040 which is being evaluated in a multicenter, open-label, phase II study for treating adults suffering from relapsed/refractory AML. Interim results are expected in the second quarter of 2014 and final study results are expected in the second half of 2014.
BioLineRx carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Questcor Pharmaceuticals Inc. (QCOR), Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals plc (JAZZ). Each stock carries a Zacks Rank #1 (Strong Buy).