08.01.2008 13:01:00
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Pluristem Announces Second Clinical Indication Revascularization Effect After PLX-PAD Therapy
Pluristem Therapeutics Inc. (NasdaqCM:PSTI)(DAX:PJT), a leading
bio-therapeutics Company dedicated to the commercialization of
non-personalized (allogeneic) cell therapy products for a variety of
malignant, ischemic and autoimmune disorders, announced today that it
has identified a second clinical indication for its proprietary PLX
cells and the expansion of its pipeline of PLX products. Pluristem’s
PLX-PAD is expected to begin clinical trials in the second half of 2008
in Europe for the treatment of limb ischemia associated with peripheral
artery disease (PAD).
Pluristem’s Chairman and CEO, Zami Aberman,
commented: "The consistent impressive results
we are obtaining in our pre-clinical in vivo studies with PLX-PAD
suggest this cellular therapy may be the first allogeneic, off-the-shelf
product to successfully treat this serious disease.”
Mr. Aberman added: "We are pleased that
PLX-PAD will join PLX-I, our first product used as an alternative to
bone marrow transplantation for treating hematological malignancies, in
building a meaningful pipeline of PLX products.”
Scientists have confirmed that studies in animals whose hind legs were
rendered ischemic using standard industry methodologies, post-treatment
evaluation using laser Doppler technology indicated revascularization of
the limbs treated with PLX-PAD cells but not in those limbs not treated
with PLX-PAD. Additionally, immunohistochemical analyses of those limbs
treated with PLX-PAD indicated a significant increase in the number of
new capillaries (vessels) supplying the limb, suggesting PLX-PAD has the
ability to promote angiogenesis (new vessel formation).
Pluristem plans to initiate Phase I clinical trials using PLX-PAD in
Europe in the second half of 2008 in collaboration with a major clinical
research institution. 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 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.
About Pluristem
Pluristem Therapeutics Inc. is a company dedicated to the
commercialization of non-personalized (allogeneic) stem cell therapy
products for the treatment of numerous severe degenerative, malignant
and autoimmune disorders. The Company's first product, PLX-I, is
directed at resolving 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 (UCB).
Pluristem's products are derived from mesenchymal stromal cells (MSCs)
obtained from the placenta, a non-controversial source, and not from
embryonic stem cells. The MSCs are expanded in the Company's proprietary
PluriXTM 3D bioreactor that imitates the
natural microstructure of bone marrow and does not require supplemental
growth factors, cytokines or other exogenous materials. Pluristem
believes the resultant expanded cells, termed PLX cells, are
multi-potent and able to differentiate into a variety of cell types.
Recent evidence also suggests their efficacy may be related to their
secretion of cytokines or other potent immune modulators. Furthermore,
PLX cells are believed to be immune-privileged and immunosuppressive,
hence protecting the recipient from immunological reactions that often
accompany transplantation.
Pluristem has offices in the USA with research and manufacturing
facilities in Israel.
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 other federal securities laws. 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. Forward-looking
statements in this release include that PLX cells show promise in
treating limb ischemia; that therapeutics used in the treatment of limb
ischemia have a potential market of over $1 Billion; that Pluristem’s
cells can potentially result in beneficial therapies for a number of
serious diseases and that the Company’s PLX
cells may be useful for treating or causing revascularization in the
disease of limb ischemia; that these results are encouraging and suggest
that our PLX cells may be the first allogeneic, off-the-shelf product to
treat this serious disease. Factors that could prevent our forward
looking statements from being achieved include that we may be unable to
get regulatory approval for our products; we may be unsuccessful in
developing any products; 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 to protect essential aspects
of our technology; competitors may invent better technology; our
products may not work as well as hoped or worse, our products may harm
recipients; and we may not be able to raise funds for development or
working capital when we require it. In addition, our products may never
develop into useful products and even if they do, they may not be
approved for sale to the public. 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, including the
Company’s latest annual report on form 10-KSB.
For more information visit our website at www.pluristem.com,
the content of which is not part of this press release.
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