Pluristem's South Korean Partner Files IND With Korean FDA for PLX Cells
July 08 2013 - 3:00AM
On the heels of announcing its strategic partnership agreement with
Cha Bio&Diostech (Kosdaq:CHA) on June 26th, Pluristem
Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of
placenta-based cell therapies, announced today that Cha
Bio&Diostech "Cha" has filed its first investigational new drug
(IND) application for Pluristem's PLacental eXpanded (PLX) cells
with the Korean Food and Drug Administration (KFDA). This IND is
for the use of PLX-PAD in the treatment of intermittent
claudication (IC) and mirrors the clinical protocol implemented by
Pluristem in its FDA supervised Phase II IC clinical trial in the
United States.
"Having just concluded our alliance with Cha, we are very
pleased with the pace at which our new partner is moving forward
towards clinical trials in South Korea," stated Zami Aberman,
Chairman and CEO of Pluristem. "We anticipate working closely with
Cha to initiate this Phase II trial in intermittent claudication as
soon as possible."
Pluristem recently announced that under the terms of its
agreement with Cha, Cha will perform and fund multiple clinical
trials in South Korea for treating critical limb ischemia (CLI) and
IC using PLX-PAD under the supervision of the KFDA. Upon the first
regulatory approval for a PLX product in South Korea, Pluristem and
Cha will establish a joint venture (JV) co-owned by the parties.
The purpose of the JV will be to commercialize PLX cell products in
South Korea. According to market research firm Clearstate, 1
million people in South Korea have PAD and the growth forecast for
the number of people diagnosed and treated in the country is
moderate-to-high.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of
placenta-based cell therapies. The Company's patented PLX
(PLacental eXpanded) cells are a drug delivery platform that
releases a cocktail of therapeutic proteins in response to a host
of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental
technology and are an "off-the-shelf" product that requires no
tissue matching prior to administration.
Pluristem has a strong intellectual property position,
company-owned GMP certified manufacturing and research facilities,
strategic relationships with major research institutions and a
seasoned management team. For more information visit
www.pluristem.com, the content of which is not part of this press
release.
The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and federal securities
laws. For example, when we discuss that we anticipate working
closely with Cha to initiate this Phase II trial in intermittent
claudication as soon as possible, we are using forward-looking
statements. These forward-looking statements and their implications
are based on the current expectations of the management of
Pluristem only, and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. The
following factors, among others, could cause actual results to
differ materially from those described in the forward-looking
statements: changes in technology and market requirements; we may
encounter delays or obstacles in launching and/or successfully
completing our clinical trials; our products may not be approved by
regulatory agencies, our technology may not be validated as we
progress further and our methods may not be accepted by the
scientific community; we may be unable to retain or attract key
employees whose knowledge is essential to the development of our
products; unforeseen scientific difficulties may develop with our
process; our products may wind up being more expensive than we
anticipate; results in the laboratory may not translate to equally
good results in real surgical settings; results of preclinical
studies may not correlate with the results of human clinical
trials; our patents may not be sufficient; our products may harm
recipients; changes in legislation; inability to timely develop and
introduce new technologies, products and applications; loss of
market share and pressure on pricing resulting from competition,
which could cause the actual results or performance of Pluristem to
differ materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, Pluristem
undertakes no obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
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CONTACT: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
1-303-883-4954
William.PratherMD@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com