Pluristem Therapeutics, Inc.
) recently announced that it has filed documents with the US Food
and Drug Administration (FDA) seeking orphan drug status for using
its PLacental eXpanded (PLX) cells to treat patients suffering from
Aplastic anemia refers to a rare, serious disorder resulting
from the destruction of blood-forming stem cells (hematopoietic
stem cells, or HSCs) in the bone marrow. We note that in normal
circumstances, HSCs develop into only red blood cells, white blood
cells and platelets. However, all blood types are deficient in
patients suffering from aplastic anemia.
In such cases, the patients are either supported with blood
transfusions ahead of a bone marrow transplant or with drugs that
cause the immune system to be suppressed. Pluristem stated in its
press release that the US market for bone marrow transplants
(including patients suffering from aplastic anemia) is worth
approximately $1.3 billion annually.
We note that on being provided with orphan drug status by the
FDA the PLX cell therapy, for treating aplastic anemia patients,
will enjoy multiple benefits including seven years of marketing
exclusivity (from the day the candidate is cleared by the FDA) in
the US for the indication.
We remind investors that Pluristem enjoys orphan drug status for
using PLX cells to treat patients suffering from Buerger's disease
since August 2011. The disease results in inflammation and clotting
of blood vessels thereby reducing the flow of blood in these
We currently have a Neutral recommendation on Pluristem. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
PLURISTEM THERA (PSTI): Free Stock Analysis
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