) has made regulatory submissions to the Finnish National
Supervisory Authority for Welfare and Health (Valvira) for
initiating a phase I/II study on the company's candidate BL-7010.
The candidate is being developed for the treatment of celiac
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BioLineRx expects to initiate the two-part (single and repeated),
double-blind, placebo-controlled, dose escalation study by year
end. The company intends to enrol 32 patients for the study. The
study will primarily evaluate the safety of single and repeated
ascending doses of BL-7010. Results should be out in mid-2014.
BioLineRx mentioned in its press release that the celiac market
is expected to reach $8 billion by 2019.
BioLineRx has progressed well on its pipeline in recent times.
Earlier this month, the company's pipeline candidate BL-8040 was
granted orphan drug designation by the U.S. Food & Drug
Administration (FDA) in the acute myeloid leukemia (AML)
BioLineRx' BL-8040 is currently in a phase II study for the
treatment of AML. BioLineRx is also evaluating BL-8040 for the
treatment of thrombocytopenia (reduced platelet production). Last
month the company reported positive results from pre-clinical
trials on the candidate, where it was proved to be effective for
the treatment of thrombocytopenia.
Apart from BL-7010 and BL-8040, BioLineRx also has BL-5010 (skin
lesions), BL-7040 (inflammatory bowel disease) and BL-1021
(neuropathic pain) in its pipeline.
BioLineRx presently carries a Zacks Rank #3 (Hold). Meanwhile,
other companies like
Anthera Pharmaceuticals, Inc.
) look better positioned. While Actelion carries a Zacks Rank #1
(Strong Buy), Anthera and Athersys carry a Zacks Rank #2