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Pluristem to Receive Clinical-hold Notice From the U.S. FDA



Pluristem to Receive Clinical-hold Notice From the U.S. FDA

HAIFA, Israel, June 4, 2013 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, announced today that it has received notification from the U.S.
Food and Drug Administration (FDA) that its United States phase II
Intermittent Claudication (IC) study (IND 15038) has been placed on clinical
hold due to a serious allergic reaction in a case which required
hospitalization.

Out of 74 patients enrolled in Pluristem's trials to date, this is the first
case of a serious allergic event. This event occurred in a patient with
multiple diseases which may have influenced the severity of the event. The
patient was discharged from the hospital the following day, following the
resolution of all her symptoms.

The FDA will issue a letter within the next 30 days detailing a list of
questions and requests for information from Pluristem.

Zami Aberman, Pluristem's Chairman and CEO, stated, "Once we receive the
letter, we will work closely with the FDA to address all issues raised. We are
committed to our strategy that our competitive technology advantage be
involved in clinical programs for multiple indications."

About a Clinical Hold

Under Food and Drug Administration (FDA) regulations, an investigational new
drug application (IND) is either allowed to proceed or placed on clinical hold
(21 CFR 312.42). A clinical hold is an order issued by the FDA to the
applicant to delay a proposed clinical investigation or to suspend an ongoing
investigation. A clinical hold may be designated either a complete clinical
hold or a partial clinical hold. Once the applicant has submitted a complete
response to the clinical hold, the FDA must evaluate the response and decide
whether to lift the hold. The FDA has committed itself to respond to the
applicant within 30 days.

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 say that we will
work closely with the FDA to address all issues raised and that we are
committed to our strategy that our competitive technology advantage be
involved in clinical programs for multiple indications 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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