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Pluristem Successfully Concludes Final Pre-Clinical Safety
Studies with PLX-PAD in Preparation for Human Trials
Wednesday September 10, 4:00 am ET
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NEW YORK--(BUSINESS
WIRE)--Pluristem Therapeutics Inc. (Nasdaq:PSTI
-
News) (DAX:PJT), a bio-therapeutics company
dedicated to the commercialization of
unrelated donor-patient (allogeneic) cell therapy products for a variety of degenerative, ischemic
and autoimmune indications, announced today the
successful conclusion of its pre-clinical
studies utilizing PLX-PAD prior to the
initiation of human clinical trials. PLX-PAD is
Pluristem’s cellular
product for the treatment of critical limb
ischemia (CLI), the end phase of Peripheral
Artery Disease (PAD).
The final studies
involved 150 animals that received single,
repeated intra-muscular (IM) injections of PLX-PAD
or a control substance then followed for up to 3
months post-injection. No adverse effects were
noted to be caused by the PLX-PAD injections
throughout the study period. Moreover, all the
histology, hematology and biochemistry panels
and biodistribution results support the safe
administration of PLX-PAD.
Previously, the
Company had reported that in animals whose hind
legs were rendered ischemic (reduction in blood
flow) using standard industry methodologies,
post-treatment evaluation using laser Doppler
technology indicated revascularization (return
of blood flow) of the limbs treated with PLX-PAD
but not in those limbs not treated with PLX-PAD.
The affected limbs’
function also improved in those animals
receiving PLX-PAD. Additionally, microscopic
analyses of those limbs treated with PLX-PAD
indicated a statistically significant increase
in the number of new capillaries (vessels)
supplying the limb, suggesting PLX-PAD has the
ability to promote angiogenesis (new vessel
formation).
Zami Aberman,
Pluristem’s President
and CEO commented, “The
successful completion of the PLX-PAD
pre-clinical phase, in accordance with the
regulatory authority's requirements, is a major
milestone. This was our final study using our
PLX-PAD. We now intend to commence human trials,
following receipt of the required regulatory
approvals. The impressive results we have
obtained in these studies give us confidence
that we will be able to prove safety in our
planned US and European dose escalation Phase
I/II human studies, followed by proof of
efficacy in our later trials.”
About Critical Limb
Ischemia
In the US alone, it is
estimated that 8-12 million people suffer from
limb ischemia associated with PAD. The disease
is characterized by narrowing and hardening of
the arteries in the patient’s
limb(s) caused and/or aggravated by diabetes,
Buerger's Disease, other diseases and smoking.
With decreased blood flow to the affected
extremity, patients can suffer a host of
complications including nerve and tissue damage.
In advanced stages, limb ischemia can lead to
gangrene, which often requires treatment with
amputation. The disease is associated with a
high rate of mortality and the need for frequent
hospitalization from surgical complications.
Industry experts have estimated that the market
for therapeutics used in the treatment of limb
ischemia to be over $1 Billion. However, current
therapeutic methodologies have proven
ineffective for many severe limb ischemic
situations and have led the medical community to
call for the development of cellular therapies,
such as Pluristem’s
PLX-PAD, as alternative treatments.
About Pluristem
Therapeutics
Pluristem Therapeutics
Inc. is a bio-therapeutics company dedicated to
the commercialization of non-personalized
(allogeneic) cell therapy products for the
treatment of several severe degenerative,
ischemic and autoimmune disorders. The Company
is developing a pipeline of products, stored
ready-to-use, that are derived from human
placenta, a non-controversial, non-embryonic,
adult stem cell source.
These placental
adherent stromal cells (ASCs) are expanded in
the Company's proprietary PluriXTM
3D bioreactor, which imitates the natural
microstructure of bone marrow and does not
require supplemental growth factors or other
exogenous materials. Pluristem believes that the
resultant PLX (PLacental eXpanded) cells’
efficacy may be related to the secretion of
cytokines or other potent immune modulators.
Furthermore, PLX cells are immune privileged and
possess immunomodulatory properties, thus
protecting the recipient from immunological
reactions that often accompany transplantations.
Pluristem's first
product in development, PLX-PAD, is intended to
improve the quality of life of millions of
people suffering from peripheral artery disease
(PAD). The Company's products in development
also include PLX-IBD, targeting Inflammatory
Bowel Disease (IBD); PLX-MS, targeting Multiple
Sclerosis; PLX-BMT, targeting the global
shortfall of matched tissue for bone marrow
transplantation (BMT) by improving the
engraftment of hematopoietic stem cells (HSCs)
contained in umbilical cord blood; and PLX-STROKE,
targeting ischemic stroke.
Pluristem has offices
in the USA with research and manufacturing
facilities in Israel.
See our product
animation on YouTube:
http://www.youtube.com/watch?v=OFhWXyJT6Us
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 this was our final study using our
PLX-PAD; that we now intend to commence human
trials, following receipt of the required
regulatory approvals and that the impressive
results we have obtained in these studies give
us confidence that we will be able to prove
safety in our planned US and European dose
escalation Phase I/II human studies, followed by
proof of efficacy in our later trials, we are
using forward-looking statements. 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:
failure to obtain required regulatory approvals,
changes in technology and market requirements;
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; 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
risk 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 RPh, MD, 303-883-4954 (Investors)
Sr. VP Corporate Development
bill@pluristem.com
Source: Pluristem
Therapeutics Inc.
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