Pluristem Receives Approval to Expand Its Phase II Clinical Trial in Intermittent Claudication to Germany

Pluristem Receives Approval to Expand Its Phase II Clinical Trial in
Intermittent Claudication to Germany

International Study Extends FDA Phase II Trial That Began in U.S.

HAIFA, Israel, Jan. 15, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-derived cell
therapies, announced today that the Paul-Ehrlich-Institute (PEI), the medical
regulatory body for biological medicinal products for the Federal Republic of
Germany, has approved the company's request to initiate a Phase II study using
PLX-PAD cells in patients suffering from Intermittent Claudication (IC). IC is
a subset of Peripheral Artery Disease (PAD). According to The SAGE Group and
HCUP 2007 Inpatient Data, the prevalence of IC in the United States is
approximately 14 million patients, representing a cost of approximately $2.5
billion annually to the healthcare system.

"This approval is part of our previously announced strategy to conduct a
multi-national study using our PLX-PAD cells in this disorder," said Zami
Aberman, Chairman and CEO of Pluristem. "We are in the process of opening
three clinical sites in Germany where the protocol will be same as the one
used in the U.S. which has already begun enrolling and dosing patients.
Additionally, we plan to expand into clinical sites in Israel, following
regulatory approval."

About the Study

Pluristem's IC Phase II is a randomized, placebo-controlled trial that will
evaluate the safety and efficacy of two doses of PLX-PAD cells versus placebo,
administered via intramuscular injections. The study protocol is comprised of
approximately 150 patients with IC: Fontaine class IIb, Rutherford category
2-3.

The primary efficacy end point of the trial is the change in the maximal
walking distance from baseline during an exercise treadmill test. Secondary
endpoints are hemodynamic and quality of life measurements. Safety parameters
are also being assessed.

About Intermittent Claudication

IC is a subset of PAD caused by atherosclerosis of the lower extremity
arteries. IC is characterized by muscle pain, such as aching, cramping,
numbness or a sense of fatigue classically in the calf muscle, which occurs
during exercise, such as walking and is relieved by a period of rest. The
prevalence of IC in the United States alone is approximately 14 million
patients and representing a cost of approximately $2.5 billion annually to the
National Healthcare Bill (References: The SAGE Group and HCUP 2007 Inpatient
Data).

About Pluristem Therapeutics

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) 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 is focusing on
the development of PLX cells administered locally to potentially treat
systemic diseases and potentially obviating the need to use the intravenous
route.

Pluristem has a strong patent and patent applications portfolio, 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, we are using forward-looking
statements when we discuss the process of opening three clinical sites in
Germany or our plan to expand into clinical sites in Israel, following
regulatory approval. These forward-looking statements 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 events. For a more detailed
description of the risks and uncertainties affecting Pluristem, reference is
made to Pluristem's reports filed from time to time with the Securities and
Exchange Commission.

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

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