Pluristem to Receive Clinical-hold Notice From the U.S. FDA
04 Juin 2013 - 3:00PM
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