The U.S. Food & Drug Administration (FDA) recently granted
orphan drug designation to
) BL-8040 for treating people suffering from acute myeloid
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We note that orphan drug designation is given to those drugs and
biologics that are meant for the safe and effective treatment,
diagnosis or prevention of rare diseases that affect not more
than 200,000 people in the U.S.
The orphan drug designation status for the candidate comes close
on the heels of the U.S. Patent and Trademark Office issuing a
new U.S. patent to BL-8040 (8,455,450). The patent, which is
expected to expire in Nov 2029, will cover BL-8040 for using its
composition for obtaining hematopoietic precursor cells (e.g.
stem cells) for use in bone marrow transplantation.
BioLineRx' BL-8040 is currently in a phase II study for the
treatment of AML. The multicenter, open-label, phase II study is
evaluating the safety and efficacy of the candidate in adults
suffering from relapsed/refractory AML. The study is also
assessing the pharmacokinetic profile of BL-8040 along with an
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. 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.
We are encouraged by the company's progress with its oncology
candidate, BL-8040. However we note that the oncology market is
extremely crowded with the presence of big companies like
BioLineRx presently carries a Zacks Rank #3 (Hold). Meanwhile,
other companies like
Gilead Sciences Inc.
) look better positioned with a Zacks Rank #1 (Strong Buy).