) 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 acute myeloid
The study is evaluating the safety and efficacy of repeated
escalating doses of BL-8040. Assessment of the safety and
tolerability of BL-8040 is the primary endpoint of the study
while secondary endpoints include the pharmacokinetic profile of
the drug and an efficacy evaluation. Initial results demonstrate
BL-8040 as safe at all doses tested till date.
The study is divided into two parts. The first part of the
study evaluates the current dose escalation phase. The second
part is the expansion phase at the highest tolerated dose
determined during the escalation phase. The dosing level of the
current study cohort is 1 mg/kg, with the highest dose being 1.5
Interim results are expected in the second quarter of 2014 and
final study results are expected in the second half of 2014.
Meanwhile, BioLineRx is also studying BL-8040 for the
treatment of thrombocytopenia (reduced platelet production). In
Aug 2013, the company reported positive results from pre-clinical
trials on the candidate, where it was proved to be effective for
the treatment of thrombocytopenia. Results further revealed that
BL-8040 increased the number of megakaryocytes (cells that
produce platelets) within the bone marrow.
We remind investors that in Sep 2012, the rights to BL-8040
were in-licensed by BioLineRx from Biokine Therapeutics Ltd.
BL-8040 has received orphan drug designation for the treatment of
AML from the U.S. Food and Drug Administration (FDA).
BioLineRx is also looking to develop BL-8040 for other
hematological indications like stem cell mobilization and chronic
myeloid leukemia. These studies will commence in the first half
With BL-8040, BioLineRx is expected to enter the oncology
market. However, big companies like
) have a presence in the oncology market.
BioLineRx currently carries a Zacks Rank #3 (Hold). A
) carries a Zacks Rank #1 (Strong Buy).
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