NEW
YORK--(BUSINESS WIRE)--Pluristem
Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT),
a bio-therapeutics company dedicated to
the commercialization of non-
personalized (allogeneic),
off-the-shelf, cell therapy products for
a variety of degenerative, ischemic and
autoimmune indications, announced today
that it has filed an Investigational
Medicinal Product Dossier (IMPD)
application with the Paul Ehrlich
Institute (PEI), the German competent
authority in the European Union (EU), to
begin clinical trials with its
placental-derived adherent stromal cell
product, termed PLX-PAD, for the
treatment of critical limb ischemia (CLI).
Assuming approval of the IMPD by this
authority, Pluristem plans to initiate
the dose ranging clinical trial during
the second quarter of 2009 at two sites
in Berlin, Germany. The patient
population for this initial clinical
trial will be considered "late stage",
defined as patients whose limb ischemia
has not responded to traditional medical
or surgical interventions and are facing
amputation. Pluristem also plans to file
shortly an Investigational New Drug (IND)
application with the Center for
Biologics Evaluation and Research (CBER)
at the Food and Drug Administration
(FDA), for a similar trial to take place
in two US clinical centers.
"We are excited about filing an IMPD
for PLX-PAD, bringing us closer to initiating our clinical trial
in critical limb ischemia in Europe," said Zami Aberman,
President & CEO of Pluristem. "Our primary goal for this trial,
as well as for the one we will begin in the US, is to prove PLX-PAD
is safe. If we are successful in this endeavor, it will have
been the first time adult stem cells, derived from placenta and
grown using our PluriXTM 3D technology, have been
administered to humans safely. We believe successful trials in
Europe and the US herald the dawn of a new era in the evolving
industry of cellular therapeutics – being able to administer an
allogeneic, off-the-shelf product that needs no matching."
Results of preclinical studies in
animal models whose limbs were rendered ischemic, using
intramuscular (IM) administration of PLX-PAD, have shown a
statistically significant increase in blood flow and formation
of new blood vessels (angiogenesis) (P<0.05). Pluristem believes
the primary mechanism underlying the potential efficacy of PLX-PAD
is one of immune modulation rather than cellular
differentiation, a hypothesis also supported by the Company’s
preclinical data.
About CLI
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 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 an IMPD
An Investigational Medicinal Product
Dossier (IMPD) is a harmonized procedure for the authorization
to perform a clinical study in any one of the EU Member States.
An IMPD is requested whenever the performance of a clinical
study in any one of the EU Member States is intended, and
it is similar to an Investigational New Drug (IND) Application
that would be filed for the performance of a clinical study in
the United States.
The IMPD includes information related
to the quality, manufacture and control of the Investigational
Medicinal Product, data from pre-clinical studies and clinical
intent-to-use. An overall risk-benefit assessment, critical
analyses of the pre-clinical data in relation to the potential
risks and benefits of the proposed study are required to be part
of the IMPD.
About Pluristem Therapeutics
