Pluristem Therapeutics, Inc.
) recently provided an update on its efforts to gain orphan drug
status for its PLacental eXpanded (PLX) cells in the treatment of
aplastic anemia. The company had submitted its application
seeking orphan drug status in the US in August 2012.
While the FDA said that aplastic anemia is indeed a rare
disease with fewer than 200,000 people suffering from it in the
US, the agency has asked the company to provide it with
additional information and data. The FDA intends to analyze the
data and information before granting orphan drug status to PLX
cells for aplastic anemia.
Meanwhile, Pluristem has moved PLX cells into a phase I/II
study which is being conducted to evaluate its safety and
efficacy in the treatment of muscle injury. Two doses of PLX
cells will be compared to placebo.
We currently have a Neutral recommendation on Pluristem, which
carries a Zacks #3 Rank (short-term Hold rating). The company is
focused on the development and subsequent commercialization of
cell therapy production technologies and products. Other
companies working in this area include
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
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