Pluristem
Therapeutics Inc. (NASDAQ:
PSTI; DAX:
PJT) is a bio-therapeutics company dedicated to
the commercialization of allogeneic (non-personalized)
cell therapy products for the treatment of a
variety of severe degenerative, ischemic and
autoimmune disorders where current therapies are
unavailable or inadequate.
PLX-PAD,
Pluristem’s first product, targets an annual $4
billion market and is intended to treat patients
suffering from the critical stage of peripheral
artery disease (PAD), manifesting as limb
ischemia. PAD affects millions of patients whose
symptoms stem from a decrease in blood supply
primarily to the lower extremities. PAD is
aggravated by conditions such as atherosclerosis,
diabetes and smoking.
PLX-PAD targets those patients where traditional
medical and surgical therapies have not helped
and are potentially facing continued symptoms or
amputation. In animal studies PLX-PAD has shown
to significantly increase the number of new
blood vessels (angiogenesis) and blood flow in
the involved extremity. Pluristem plans for
human studies to begin later in 2008.
PLX-I,
Pluristem’s second product, targets an annual $2
billion market and is intended to resolve the
global shortfall of matched hematopoietic stem
cells (HSCs) for bone marrow transplantation (BMT).
Approximately 60% of the 150,000 patients
diagnosed annually with leukemia and other
hematological malignancies are unable to find a
suitable bone marrow donor match and are left
with no reasonable therapeutic alternatives. In
animals PLX-I, combined with the HSCs found in
umbilical cord blood (UCB), has been shown to
significantly increase the engraftment of these
HSCs in bone marrow. Therefore, Pluristem
believes it has potentially found an alternative
to bone marrow transplantation by using UCB with
PLX-I, an off-the-shelf product that requires no
matching. Pluristem expects human trials to
begin in early 2009.
PLX-STROKE
targets an annual $4 billion market and shows
potential to become a new treatment for
the functional recovery from an ischemic stroke.
In addition to PLX-PAD, PLX-I and PLX-STROKE,
Pluristem has animal data that suggests its PLX
cells are of value in meeting an unmet need in
the treatment of other disorders such as
Multiple Sclerosis )MS)
and Crohn’s Disease. Moreover, Pluristem
believes its PLX cells are also potentially
useful for other indications such as organ
transplantation, orthopedic injuries and
preventing radiation sickness.
Pluristem’s pipeline
of products begins as mesenchymal stromal cells
(MSCs) that are derived from the human placenta,
an organ that has traditionally been considered
medical waste after childbirth and a non-embryonic,
non-controversial source of cells. Pluristem’s
placental-derived MSCs are then grown in a
unique and proprietary three-dimensional (3D)
microenvironment, termed the Pluristem PluriX™
3D bioreactor, without the addition of growth
factors or other adulterants. The MSCs derived
from this process are called PLacental eXpanded
or PLX cells. Pluristem believes these
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, these
PLX cells are immune-privileged and possess
immunomodulatory properties, thus
protecting the recipient from immunological
reactions that often accompany transplantations.
The PLX cells are
stored “ready to use” with no
histocompatibility
matching required.
Pluristem is an American public company that
employs 25 talented, experienced individuals
including three PhDs and an MD. The Company has
an office in Colorado with headquarters housing
its research and development and FDA good
manufacturing practices (GMP)-approved
facilities in Haifa, Israel.
