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Pluristem Presents Final PLX-PAD Efficacy Data Supporting
Upcoming IND Submission to the U.S. FDA
Tuesday September 16, 3:24 am ET
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PLX-PAD could become
an effective therapeutic alternative for diabetics,
smokers and others who are at risk of amputation
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
efficacy 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 stage of Peripheral Artery Disease
(PAD).
The final efficacy studies involved
110 animals whose hind legs were rendered ischemic
(reduction in blood flow) using standard industry
methodologies. The animals received intra-muscular
(IM) injections of six different batches of PLX-PAD
or a control substance at two separate sites in the
ischemic limb then followed for up to 30 days
post-injection. At the end of the study period,
those animals receiving PLX-PAD had a statistically
significant increase in blood flow, angiogenesis
(new blood vessel growth) and functionality. In
addition, those animals receiving PLX-PAD had an
absence of necrosis (tissue loss) in the affected
limb compared to several instances of necrosis in
the control animals. These studies confirm results
of trials previously performed in proof-of-concept
studies using PLX-PAD.
Zami Aberman, Pluristem’s
President and CEO commented, “These
final PLX-PAD efficacy studies show impressive new
vessel formation and may bring hope to millions of
people suffering from complications of diabetes,
Buerger's Disease and smoking where insufficient
blood flow to their lower legs places them at risk
of amputation. The successful completion of the PLX-PAD
pre-clinical efficacy trials, in accordance with the
regulatory authority's requirements, validates the
results we obtained in our previous studies with
this product and gives us assurances that allogeneic
adherent stromal cells will be efficacious for this
disorder. This was our final pre-clinical efficacy
study using PLX-PAD and we now intend to commence
human trials, following receipt of the necessary
regulatory approvals.”
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 unrelated donor-patient (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=QzAANdeg0b0, the
content of which is not part of this press release.
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 PLX-PAD could
become an effective therapeutic alternative for
diabetics, smokers and others who are at risk of
amputation, or that these final PLX-PAD efficacy
studies show impressive new vessel formation and may
bring hope to millions of people suffering from
complications of diabetes, Buerger's Disease and
smoking where insufficient blood flow to their lower
legs places them at risk of amputation, or that the
successful completion of the PLX-PAD pre-clinical
efficacy trials, in accordance with the regulatory
authority's requirements, validates the results we
obtained in our previous studies with this product
and gives us assurances that allogeneic adherent
stromal cells will be efficacious for this disorder,
or that this was our final pre-clinical efficacy
study using PLX-PAD and we now intend to commence
human trials, following receipt of the necessary
regulatory approvals, 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 Investor Contact:
William Prather RPh, MD, 303-883-4954
Sr. VP Corporate Development
bill@pluristem.com
Source: Pluristem Therapeutics Inc.
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