FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem's
Regulatory Submissions in Support of a Phase I/II Clinical Trial
Utilizing PLX-PAD for Peripheral Artery Disease
2008-05-06 20:54:59 -
www.pluristem.
(DAX:PJT), a bio-therapeutics company dedicated to the
commercialization of non-personalized (allogeneic) cell therapy
products for a variety of degenerative, ischemic and autoimmune
indications, announced today that the Paul Ehrlich Institute (PEI) in
Germany has approved the pre-clinical study synopsis to support a
Phase I/II clinical trials in Germany and that the
Center for Biologics Evaluation and Research (CBER), a division of
the US Food and Drug Administration (FDA), has approved the synopsis
to conduct a Phase I clinical trial in the US utilizing PLX-PAD for
the treatment of limb ischemia associated with peripheral artery
disease (PAD). The PEI is the German federal authority granting
clinical trial approvals.
PLX-PAD are mesenchymal stromal cells (MSCs) obtained from the
placenta and expanded using Pluristem's proprietary 3D PluriX(TM)
technology
The regulatory and scientific package submitted to both authorities
contains detailed information on the clinical indication, product
properties, the Good Manufacturing Practices (GMP) manufacturing
process for the production of PLX-PAD, and the clinical protocol
synopsis for the planned Phase I/II clinical trial. The package also
contains information on the safety and biodistribution study designs
required to file an investigational new drug (IND) application.
Mr. Zami Aberman, Pluristem's President & CEO, stated: "I am proud
that our team has accomplished this important milestone in achieving
the FDA and PEI approval of our clinical route. We believe that this
now paves the way to submit an IND using PLX-PAD for limb ischemia
this summer and hopefully begin our Phase I/II clinical trials in
2008."
About Limb Ischemia
In the US alone, it is estimated that 8-12 million people suffer from
limb ischemia associated with peripheral artery disease (PAD). The
disease is characterized by narrowing and hardening of the arteries
in the patient's limb(s) caused and/or aggravated by conditions such
as diabetes, Buerger's Disease 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 current market for therapeutics and other
interventions to treat limb ischemia is estimated to be approximately
$1.2 billion.
About Pluristem
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 the
human placenta, a non-controversial, non-embryonic, adult stem cell
source.
These placental mesenchymal stromal cells (MSCs) are expanded in the
Company's proprietary PluriX(TM) 3D bioreactor, which imitates the
natural microstructure of bone marrow and does not require
supplemental growth factors or other exogenous materials. Pluristem
believes the resultant PLX (PLacental eXpanded) cells are multi-
potent and able to differentiate into a variety of cell types. Recent
evidence also suggests their efficacy may be related to the secretion
of cytokines or other potent immune modulators. Furthermore, PLX
cells are immune privileged and have 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-I, 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; PLX-STROKE, targeting ischemic stroke victims; and PLX-
MS, targeting Multiple Sclerosis.
Pluristem has offices in the USA with research and manufacturing
facilities in Israel.
See our product animation on YouTube: www.youtube.
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 we believe that this now paves the way to
submit an IND using PLX-PAD for limb ischemia this summer and
hopefully begin our Phase I/II clinical trials in 2008, we believe
that this now paves the way to submit an IND using PLX-PAD for limb
ischemia this summer and hopefully begin our Phase I/II clinical
trial in 2008, 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: 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.
For more information visit our website at www.pluristem.
content of which is not part of this press release.
Pluristem Therapeutics Inc.
William Prather RPh, MD, 303-883-4954
Sr. VP Corporate Development
bill@pluristem.
http://www.pr-
r575158.htm
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