Manufacturing Approval for Pluristem Facility - Analyst Blog
28 Januar 2014 - 11:50PM
Zacks
Pluristem Therapeutics, Inc. (PSTI) develops
placenta-based cell therapies in collaboration with companies like
United Therapeutics (UTHR) 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 disease (PAD).
The company recently received approval from the
Paul-Ehrlich-Institute (PEI), Germany's health authority, for its
state-of-the-art facility.
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 tendons.
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 muscle injury.
Meanwhile, Celgene Cellular Therapeutics, a wholly owned
subsidiary of Celgene Corp. (CELG), is also doing
research on stem cells derived from the human placenta as well as
from the umbilical cord for the treatment of different
diseases.
Pluristem currently carries a Zacks Rank #3 (Hold). A
better-ranked stock in the same sector is Actelion
Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
CELGENE CORP (CELG): Free Stock Analysis Report
PLURISTEM THERA (PSTI): Free Stock Analysis Report
UTD THERAPEUTIC (UTHR): Free Stock Analysis Report
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