Pluristem Therapeutics Inc.
) recently received a major relief when the U.S. Food and Drug
Administration (FDA) lifted the clinical hold on its phase II
intermittent claudication (IC) study (IND 15038).
Shares of the company reacted positively to the
We note that the clinical hold was lifted after Pluristem
addressed all issues raised by the FDA while placing the clinical
We remind investors that on Jun 4, 2013, the company was
informed that the FDA has placed a clinical hold on its phase II
IC study following a serious allergic reaction in one of the
patients who required subsequent hospitalization.
The patient was discharged the next day after the symptoms
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
issues. The company also provided information from a database
compiled from previous clinical studies.
We note that Pluristem develops placenta-based cell therapies
in collaboration with companies like
) or through research and clinical institutions.
The cells from placenta are derived using the company's
proprietary PluriX therapy and are known as PLacental eXpanded
(PLX) cells. Pluristem's first candidate in development, PLX-PAD,
is intended to treat peripheral artery disease (PAD).
With the clinical hold uplifted, Pluristem can now proceed
with its phase II IC study which uses the proprietary PLX-PAD
Meanwhile, Celgene Cellular Therapeutics, a wholly-owned
), is also conducting research on stem cells derived from the
human placenta and from the umbilical cord for the treatment of
Pluristem carries a Zacks Rank #4 (Sell). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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