United Therapeutics Receives Regulatory Approval to Commence Phase I Study of Pluristem's PLX-PAD Cells for Pulmonary Arterial
April 11 2013 - 2:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading
developer of placenta-based cell therapies, announced today that
following favorable preclinical studies, United Therapeutics
Corporation received approval to perform a human Phase I study in
Australia using Pluristem's PLacental eXpanded (PLX-PAD) cells in
patients diagnosed with Pulmonary Arterial Hypertension (PAH). On
June 20, 2011 United Therapeutics and Pluristem entered into a
licensing agreement pursuant to which United Therapeutics will
develop, market and sell Pluristem's PLX-PAD cells for PAH.
PAH is characterized by abnormally high blood pressure in the
arteries of the lungs and leads to an increased workload on the
right side of the heart.
United Therapeutics plans to conduct a single center,
open-label, dose-escalation study in patients diagnosed with PAH.
The study will enroll up to nine patients in three dosing levels
with PLX-PAD cells administered intravenously (IV). The primary
endpoint of the study is to evaluate the safety of PLX-PAD cells in
a follow-up period of one year. Secondary efficacy endpoints at six
weeks post-treatment are designed to assess cardio-respiratory
function and include six-minute walk distance, cardiac hemodynamic
parameters via a right heart catheterization and echocardiogram and
pulmonary metabolism via a positron emission tomography (PET) scan.
Zami Aberman, Chairman and Chief Executive Officer of Pluristem
Therapeutics stated, "We are very pleased with the progress of the
project, moving our partnership with United Therapeutics to the
next step. The in-vitro and pre-clinical development studies
demonstrated that the administration of PLX-PAD cells appears to be
safe and potentially effective in animal models of PAH. We are now
looking forward to receiving clinical data from this trial in
evaluating the safety of our PLX-PAD cell in treating PAH
patients."
Under the terms of Pluristem's licensing agreement with United
Therapeutics Corporation, United Therapeutics made an upfront
payment of $7 million to Pluristem. Pluristem is also eligible to
receive regulatory milestone and other payments totaling up to an
additional $48 million with United Therapeutics bearing all the
costs of conducting all of the clinical trials for the indication
of PAH. The licensing agreement also provides that, following
commercialization, United Therapeutics will purchase the PLX-PAD
cell product from Pluristem at a specified margin over Pluristem's
cost. In addition, United Therapeutics will pay Pluristem specified
royalties as a percentage of its gross profits generated from the
sale of the PLX-PAD cell developed product.
Preclinical studies to evaluate the hemodynamic effects from the
IV administration of PLX-PAD cells in the monocrotaline (MCT) rat
model of PAH have been performed. These studies demonstrated that
PLX-PAD cell treatment can lead to improvements in right
ventricular systolic pressure (RVSP) compared to placebo-treated
animals. Some treatment groups also demonstrated an improvement in
right ventricular hypertrophy (RVH) as compared to placebo-treated
animals.
About United Therapeutics
United Therapeutics Corporation is a biotechnology company
focused on the development and commercialization of unique products
to address the unmet medical needs of patients with chronic and
life-threatening diseases.
About Pluristem Therapeutics
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 development of PLX cells administered locally to
potentially treat systemic diseases and potentially obviating the
need to use the intravenous route.
Pluristem has a strong patent and patent applications portfolio,
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, we are using forward-looking statements when (a)
we discuss the planned study in patients diagnosed with PAH, (b) we
discuss the safety of PLX-PAD in treating PAH patients, and (c) we
discuss future milestone-based payments, royalty payments and
purchase of PLX-PAD cells for the indication of PAH, by United
Therapeutics. 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
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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