Pluristem Therapeutics, Inc.
) recently announced that it has taken possession of its new
state-of-the-art facility after initiating the validation
process earlier in Jan 2013.
Pluristem is currently shifting its manufacturing process to
this facility. According to Pluristem, this is the world's first
commercial cell therapy manufacturing facility.
Pluristem, headquartered in Israel, develops placenta based
cell therapies. The cells from placenta are derived using the
company's proprietary PluriX therapy and are known as PLacental
eXpanded (PLX) cells.
The new facility will enable Pluristem to produce large
quantities of PLX cells using its patented 3D bioreactor
technology. In addition, the new manufacturing facility will
allow Pluristem to produce different PLX candidates with the
potential capacity of over 150,000 doses on an annual
We note that Pluristem develops and manufactures cell therapy
products in collaboration with companies like
) or through research and clinical institutions.
Management believes that PLX cells can be effective in
supporting bone marrow transplantation and in treating bone
marrow suppression from radiation and chemotherapy.
We remind investors that the medical regulatory body for
biological medicinal products in Germany, the
Paul-Ehrlich-Institute (PEI), has approved the company's request
to conduct a phase II study using PLX-PAD cells in patients
suffering from intermittent claudication (IC).
IC is a subset of peripheral artery disease (PAD). The
phase II study for IC will be a placebo-controlled trial wherein
the safety and efficacy of two doses of PLX-PAD cells will be
compared to placebo among 150 patients.
According to the SAGE Group and HCUP 2007 inpatient data,
approximately 14 million people in the US suffer from IC,
representing a cost of approximately $2.5 billion on an annual
basis to the healthcare system.
Pluristem plans to open three clinical sites in Germany where
the protocol will be same as in the US where patient enrollment
and dosing is in progress. Moreover, the company plans to
open clinical sites in Israel, once regulatory approval is
Meanwhile, Celgene Cellular Therapeutics, a wholly-owned
) is also doing research on stem cells derived from the human
placenta as well as from the umbilical cord for the treatment of
Pluristem carries a Zacks Rank #3 (Hold). Pharma stocks, such
), currently appear to be attractive with a Zacks Rank #1 (Strong
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