FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication Study
September 16 2013 - 3:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today that
the U.S. Food and Drug Administration (FDA) has lifted the clinical
hold previously placed on the Company's U.S. Phase II Intermittent
Claudication (IC) study (IND 15038) on June 4, 2013.
In its letter to Pluristem, the FDA indicated Pluristem had
satisfactorily addressed all the clinical hold issues and the
Company may proceed with the study.
Zami Aberman, Pluristem's Chairman and CEO commented, "Pluristem
applauds the FDA's vigor to resolve this clinical hold as quickly
as possible. We look forward to resuming this important study that
addresses the growing, costly and potential serious indication of
intermittent claudication."
About Pluristem's Phase II Intermittent Claudication
(IC) Clinical Trial
Pluristem's Phase II Intermittent Claudication (IC) study uses
the Company's PLX-PAD cells. Up to 150 patients will be enrolled in
this dose escalation, randomized, double blind, multicenter,
multinational, placebo-controlled trial whose primary endpoints at
12 months will be safety and maximal walking distance relative to
baseline. The study protocol will be modified by tightening
patient's eligibility criteria and by adding oral anti-histamines
and a safety follow-up period for 24 hours post study
treatment.
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 the PLX-PAD Phase II
Intermittent Claudication (IC) study, 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 (NASDAQ:PSTI)
Historical Stock Chart
From Apr 2024 to May 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From May 2023 to May 2024