Pluristem Therapeutics, Inc.
) develops placenta-based cell therapies in collaboration with
) or through research and clinical institutions. The cells from
placenta are derived using the company's proprietary PluriX
therapy and are known as PLX cells. Pluristem's first candidate
in development, PLX-PAD, is intended to treat peripheral artery
The company recently received approval from the
Paul-Ehrlich-Institute (PEI), Germany's health authority, for its
The new facility is fully automated and equipped with
proprietary 3D cell expansion manufacturing platform. The new
facility allows Pluristem to efficiently produce over 150,000
doses of PLX cells annually.
The approval of this new facility will support Pluristem's
ongoing trials and will enable it to enter into multiple clinical
trials using its expanded manufacturing capabilities. Pluristem
expects to obtain approval from other regulatory authorities as
well including the U.S. Food and Drug Administration (FDA).
Last week, Pluristem released positive top-line results from a
phase I/II trial evaluating the safety and efficacy of PLX-PAD
cells in the treatment of muscle injury. The study met both the
primary and secondary endpoints. The results from the trial
showed that PLX-PAD cells were safe and statistical significance
was reached for the primary efficacy endpoint.
The results indicated that PLX cells might be efficacious in
the treatment of orthopedic injuries including muscles and
We are encouraged by the recent bout of news at Pluristem
which bodes well for future clinical trials - the approval of a
new facility and positive results from the clinical trial
demonstrating the efficacy of PLX cells in the treatment of
Meanwhile, Celgene Cellular Therapeutics, a wholly owned
), is also doing research on stem cells derived from the human
placenta as well as from the umbilical cord for the treatment of
Pluristem currently carries a Zacks Rank #3 (Hold). A
better-ranked stock in the same sector is
) with a Zacks Rank #1 (Strong Buy).
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