Pipeline updates are highly awaited events for investors in
the pharma/biotech sector as they play an important role in
deciding whether or not to invest in a particular company. These
companies spend a significant amount in advancing their
One such biopharma company is
) whose pipeline includes candidates like BL-8040 (acute myeloid
leukemia (AML) and other hematological cancer indications,
currently in a phase II study), BL-5010 (non-surgical removal of
skin lesions, a pivotal CE-mark registration trial to start in
the first half of 2014), BL-1040 (preventing pathological cardiac
remodelling following a myocardial infarction, currently in a
pivotal CE-Mark registration trial) and BL-7010 (for celiac
disease, currently in a phase I/II study).
Recently, BioLineRx announced the successful completion of the
single administration, dose-escalation stage of the ongoing phase
I/II study on BL-7010. BL-7010 is being evaluated for the
treatment of celiac disease. The results showed positive safety
and tolerability levels. There were no dose-limiting safety
issues and serious adverse events found.
The repeated administration stage of the study will soon be
initiated. In this stage of the study, patients will receive
either BL-7010 or placebo thrice per day for a period of two
weeks. Results from the phase I/II study will be out in mid-2014.
Assuming successful completion of this study, BioLineRx expects
to conduct a randomized, controlled, efficacy study at the end of
this year, in patients suffering from celiac disease.
In the ongoing 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. The secondary
endpoint is the assessment of systemic exposure of BL-7010 in
We note that BL-7010 is developed by BioLineRx under a
worldwide exclusive license agreement with Univalor.
BioLineRx carries a Zacks Rank #2 (Buy). Investors looking for
better-ranked stocks in the biopharma sector may consider
Questcor Pharmaceuticals, Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
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