Pluristem Study to Expand to Germany - Analyst Blog
January 16 2013 - 1:00PM
Zacks
Pluristem Therapeutics, Inc. (PSTI) recently
announced that the medical regulatory body for biological medicinal
products in Germany, the Paul-Ehrlich-Institute (PEI), has approved
the company’s request to conduct a phase II study using PLX-PAD
cells in patients suffering from intermittent claudication
(IC).
Pluristem develops standardized cell therapy products from
human placenta for the treatment of multiple disorders. The cells
from placenta are derived using the company’s proprietary PluriX
therapy and are known as PLacental eXpanded (PLX) cells. IC is a
subset of peripheral artery disease (PAD).
The phase II study for IC will be a placebo-controlled trial
wherein the safety and efficacy of two doses of PLX-PAD cells will
be compared to placebo among 150 patients.
The key endpoint of the trial is the change in the maximal
walking distance from baseline during an exercise treadmill test
while secondary endpoints are hemodynamic and quality of life
measurements.
According to The SAGE Group and HCUP 2007 Inpatient Data,
approximately 14 million people in the US suffer from IC
representing a cost of approximately $2.5 billion on an annual
basis to the healthcare system.
Pluristem plans to open three clinical sites in Germany where
the protocol will be same as the one used in the US where patient
enrolment and dosing is in progress. Moreover, the company
plans to open clinical sites in Israel, once regulatory approval is
received.
We note that Pluristem develops and manufactures cell therapy
products in collaboration with companies like United Therapeutics
Corporation (UTHR) or through research and clinical
institutions.
We currently have a Neutral recommendation on Pluristem, which
carries a Zacks Rank #3 (Hold). Celgene Cellular Therapeutics, a
wholly owned subsidiary of Celgene Corporation
(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.
Currently, Celgene looks attractive with a Zacks Rank #2
(Buy).
CELGENE CORP (CELG): Free Stock Analysis Report
PRO-ULS L7-10YT (PST): ETF Research Reports
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