Pluristem Therapeutics, Inc.
) recently announced that it will be initiating phase II studies
that will evaluate the safety and efficacy of its placental
expanded (PLX) cells in treating intermittent claudication (IC), a
subset of peripheral artery disease (PAD). A study will be
initiated in the US in the first week of September.
Notably, in April this year, the US Food and Drug Administration
(FDA) had granted permission to Pluristem to initiate the IC phase
II trial. The company already received approval from the
Institutional Review Board (IRB) for its protocol. Trial protocol
for 5 out of the 11 clinical sites in the US was approved by the
Pluristem plans to begin its site initiations with Duke
University Medical Center on September 5 this year, which will be
followed by other sites in the succeeding weeks. The company also
plans site initiations in Europe and Israel besides the 11 sites in
The phase II trial will be evaluating the safety and efficacy of
two different doses of PLX-PAD cells in comparison with placebo.
The study will consist of around 150 patients and the primary
endpoint will be the change in maximum walking distance from
We note that earlier this month, Pluristem had extended its
five-year old collaboration research agreement with the
Berlin-Brandenburg Center for Regenerative Therapy (BCRT) at
Charite - University Medicine Berlin. Pluristem and BCRT
collaborated for several indications using the company's patented
PLX cells. The company targets a lucrative market worth up to $16.5
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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