Pluristem Therapeutics Inc.
) received positive news when the Israeli Ministry of Health
approved its request to initiate a phase II study using its
PLacental eXpanded (PLX) cells for the intermittent claudication
IC is a subset of peripheral artery disease (PAD). Pluristem
develops placenta-based cell therapies. The cells from placenta
are derived using the company's proprietary PluriX therapy and
are known as PLX cells.
The phase II IC study will evaluate the efficacy of two doses
of PLX-PAD cells compared to placebo, administered via
intramuscular injections. The primary end point of the trial is
the change in the maximal walking distance from baseline during
an exercise treadmill test while secondary endpoints include
hemodynamic and quality of life measurements.
The protocol will be the same as the one used in the U.S
Last month, Pluristem received a major relief when the U.S.
Food and Drug Administration (FDA) lifted the clinical hold on
its phase II IC study. We note that the clinical hold was lifted
after Pluristem addressed all issues raised by the FDA while
placing the clinical hold.
We remind investors that the FDA placed a clinical hold on the
company's phase II IC study in Jun 2013 following a serious
allergic reaction in one of the patients who required subsequent
hospitalization. The patient was discharged the next day after
the symptoms were managed.
Pluristem pointed out that the patient was suffering from
multiple diseases which might have affected the severity of the
Consequently, Pluristem provided the agency with additional
information so as to speed up the review and resolution of the
We note that Pluristem develops placenta-based cell therapies
in collaboration with companies like
) or through research and clinical institutions.
Pluristem carries a Zacks Rank #4 (Sell). Right now,
) look attractive. While Actelion carries a Zacks Rank #1 (Strong
Buy), Athersys carries a Zacks Rank #2 (Buy).
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