Pluristem Therapeutics, Inc.
) recently announced the initiation of the final validation steps
for its new state-of-the-art manufacturing facility. Subsequent
to this validation, Pluristem will take possession of the
The validation process include the validation of several
installation systems including heating, ventilation and air
conditioning (HVAC), water, oil free air and sterile room
According to Pluristem, this facility is the world's first
commercial cell therapy manufacturing facility.
Pluristem 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 have the capacity to produce PLX cells
for the treatment of over 150,000 patients per annum representing
$1 billion in production value if and when the PLX cells product
are successfully developed and approved by the
In addition, the new facility will enable Pluristem to supply
PLX cells to conduct clinical trials which are approved by
regulators for additional indications.
We note that Pluristem has collaboration deals with companies
United Therapeutics Corporation
Management believes that PLX cells can be effective in
supporting bone marrow transplantation and in treating bone
marrow suppression from radiation and chemotherapy.
Earlier, Pluristem had announced that the US Food and Drug
Administration (FDA) updated the former related to its
application to designate PLX cells orphan drug status in the
treatment of aplastic anemia.
According to FDA, Pluristem is required to provide additional
information and data for further analysis before the FDA can
determine if the PLX cells can qualify for orphan drug
designation for aplastic anemia, which affects less than 200,000
people in the US.
Celgene Cellular Therapeutics, a wholly owned subsidiary of
is also doing research on stem cells derived from the human
placenta as well as from the umbilical cord for the treatment of
We currently have a Neutral recommendation on Pluristem, which
carries a Zacks #3 Rank (Hold).
CELGENE CORP (CELG): Free Stock Analysis
PLURISTEM THERA (PSTI): Free Stock Analysis
UTD THERAPEUTIC (UTHR): Free Stock Analysis
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