Pluristem Reports Status of Orphan Drug Application for Aplastic Anemia
FDA Acknowledges Aplastic Anemia as Rare Disease and Requests Further Data
From the Company in Connection With Application
HAIFA, Israel, Nov. 21, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc.
(Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell
therapies, today announced that the U.S. Food and Drug Administration (FDA)
has updated the Company on its application to designate Pluristem's PLacental
eXpanded (PLX) cells orphan drug status in the treatment of aplastic anemia.
The FDA acknowledged that aplastic anemia is a rare disease with prevalence in
the United States of less than 200,000. This serves as confirmation that
aplastic anemia is an indication for which candidate treatments are eligible
for orphan drug status. The FDA has also requested that Pluristem provide
additional information and data for further analysis before the FDA can
determine if the PLX cells can qualify for orphan drug designation for
"We look forward to providing the additional information that the FDA needs in
connection with our orphan drug status application for Aplastic Anemia. We
appreciate the very productive working relationship we have with the FDA, as
we present PLX cells as candidates for the treatment of a range of therapeutic
indications," stated Zami Aberman, Chairman and CEO of Pluristem.
About Orphan Drug Status
Orphan drug designation qualifies a company for several benefits under the
Orphan Drug Act of 1983 (ODA), as amended. These benefits include a 7-year
period of orphan drug exclusivity upon product approval, a tax credit for
certain clinical testing expenses for the orphan drug, written guidance on the
non-clinical and clinical studies needed to obtain marketing approval of an
orphan drug, and orphan drug grants.
About Pluristem Therapeutics Inc.
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 use of PLX cells administered locally to treat systemic diseases and
potentially obviating the need to use the intravenous route.
Pluristem has a strong patent portfolio, GMP certified manufacturing and
research facilities as well as strategic relationships with major research
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
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 say that we look forward to providing the additional
information that the FDA needs, or when we discuss presenting our PLX cells as
candidates for treatment of a range of therapeutic indications. 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 our clinical
trials; 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; 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
Director Investor & Media Relations
Pluristem Therapeutics Inc. Logo
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