Pluristem Therapeutics Inc.
) recently announced that it has provided the US Food and Drug
Administration (FDA) with additional information regarding the
clinical trials for intermittent claudication (IC) pursuant to a
clinical hold on the phase II IC study earlier this month.
We remind investors that on Jun 4, 2013, the company was
informed that the FDA has placed a clinical hold on a 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 were managed.
Pluristem pointed out that the patient was suffering from
multiple diseases which might have affected the severity of the
Although the 30-day period within which the FDA is expected to
provide a letter to the company containing a list of questions
and information required is yet to expire, Pluristem has already
provided the agency with additional information so as to speed up
the review and resolution of the issues. The company provided
information from a database compiled from previous clinical
Meanwhile, as the study is being conducted both in the US and
Germany, Pluristem informed the Paul-Ehrlich-Institute (PEI) in
Germany about the clinical hold by the FDA and provided relevant
information. Consequently, the IC study in Germany has also
been put on hold.
Pluristem develops placenta-based cell therapies and currently
does not have any approved product/therapy. Hence, a hold on the
mid-stage trial in the US and Germany is a major setback for the
We expect investor focus in the near term to remain on further
updates on the clinical hold.
Celgene Cellular Therapeutics, a wholly-owned subsidiary
), is also conducting research on stem cells derived from the
human placenta as well as from the umbilical cord for the
treatment of different diseases.
Pluristem carries a Zacks Rank #4 (Sell). Right now,
Biogen Idec, Inc
Aeterna Zentaris, Inc
) look attractive. While Biogen Idec carries a Zacks Rank #1
(Strong Buy), Aeterna Zentaris carries a Zacks Rank #2
AETERNA ZENTARS (AEZS): Free Stock Analysis
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PLURISTEM THERA (PSTI): Free Stock Analysis
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