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Pluristem Provides Update on Clinical Status of IC Trials



Pluristem Provides Update on Clinical Status of IC Trials

HAIFA, Israel, June 19, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, provided an update today on the status of its clinical trials in
Intermittent Claudication (IC):

  * As previously announced, on June 4, 2013 the company received notification
    from the U.S. Food & Drug Administration (FDA) that its U.S. phase II IC
    trial was put on hold following the hospitalization of a patient with an
    allergic reaction in the company's IC trial in the United States. The
    patient, who suffers from a number of severe background diseases
    (including oxygen-dependent chronic obstructive pulmonary disease) in
    addition to IC, experienced a rash and shortness of breath following the
    treatment. She was admitted to a local hospital and discharged the
    following day after resolution of her symptoms.
  * According to FDA regulations, within 30 days of the notification of the
    clinical hold, the FDA is to provide Pluristem with a letter detailing a
    list of questions and requests for information from the Company. Pluristem
    has not yet received this letter.
  * In order to accelerate the review of the relevant facts and resolution of
    the issues, Pluristem has already provided the FDA with additional
    information and aggregate safety analyses based on the database compiled
    by the company from its previous clinical studies.
  * Since the IC study is a multi-national trial being conducted under
    identical study designs in both the U.S. and Germany, Pluristem advised
    the Paul-Ehrlich-Institute (PEI) in Germany about the FDA clinical hold
    and provided relevant information. Following further communication with
    the PEI, and in order to maintain consistency among the study protocols,
    the company has issued an amendment to the protocol putting the IC study
    in Germany on hold in order to provide more comprehensive analysis, and a
    risk minimization proposed plan.

Zami Aberman, Pluristem's Chairman and CEO, stated, "We continue to work
closely and transparently with the FDA and PEI to address all issues in the IC
clinical study. Pluristem is committed to resolve this issue and to provide
the regulatory agencies the information needed to ensure the maintenance of
patient safety and wellbeing and to move forward with this clinical trial as
soon as possible."

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 providing
the regulatory agencies the information needed to ensure the maintenance of
patient safety and wellbeing in order to move forward with our clinical trials
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 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

Pluristem Therapeutics Inc. Logo
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