Pluristem Advances Towards U.S. Clinical Trial in PLX-R18 and Announces Principal Investigator
September 14 2016 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
the appointment of Dr. Hillard Lazarus of Case Western Reserve
University as the Principal Investigator of the Company’s Phase I
trial of its PLacental eXpanded (PLX)-R18 cells to treat incomplete
hematopoietic recovery following hematopoietic cell transplantation
(HCT).
Enrollment for the Phase I trial, which was
recently cleared by the U.S. Food and Drug Administration, is
expected to begin in the coming months at multiple clinical sites
in the U.S. The open label, dose escalating study will evaluate the
safety of intramuscular injections of PLX-R18 in 30 patients with
incomplete hematopoietic recovery following HCT. Additional
endpoints will include changes in platelet and hemoglobin levels,
transfusion frequency, frequency of shift from transfusion
dependence to transfusion independence, quality of life, and
various immunological parameters in the blood.
Dr. Lazarus is a Professor of Medicine at Case
Western Reserve University and doctor of Hematology-Oncology at
University Hospitals Case Medical Center. He is the George &
Edith Richman Professor and Distinguished Scientist in Cancer
Research and Director of Novel Cell Therapy. He was Director of the
Blood and Marrow Transplant Program for over 25 years. For the past
decade, he has been the Principal Investigator of the Case
Consortium of the Blood & Marrow Transplant Clinical Trials
Network. Having developed many new anti-cancer therapies and
sophisticated supportive care technologies, Dr. Lazarus is
internationally recognized for his contributions in several areas,
including mesenchymal stem cell transplantation and allogeneic
blood and marrow transplantation for malignancies. Dr. Lazarus has
over 600 publications to his name and is the Editor-in-Chief of
both Bone Marrow Transplantation and Blood Reviews. He is a member
of Pluristem’s clinical advisory board for the development of
PLX-R18 in hematology, and was actively involved in both the
selection of the indication and the study design.
“We are pleased and honored that Dr. Lazarus
will lead our Phase I trial as Principal Investigator. His
extensive experience in the field of hematologic-oncology is an
asset to our PLX-R18 development program,” stated Pluristem
Chairman and CEO Zami Aberman.
“Having previously studied the potential of
PLX-R18 in pre-clinical settings to improve outcomes for umbilical
cord blood stem cell transplantation, I am eager to lead a clinical
trial to explore PLX-R18’s benefits in hematologic recovery
following HCT,” commented Dr. Lazarus. “Positive clinical data
could support further development of PLX-R18 to increase the
success rates of transplants used to treat a broad range of
indications.”
About PLX-R18
PLX-R18 is Pluristem’s second cell therapy
product cleared for clinical studies by the U.S. FDA. It has
already been studied in preclinical models of acute radiation
syndrome, support of hematopoietic cell transplants, and side
effects of radiotherapy and chemotherapies used to treat cancers.
Preclinical data from trials conducted by the U.S. National
Institutes of Health, Hadassah Medical Center, and other prominent
research institutions have shown that PLX-R18 cells secrete a range
of specific proteins that trigger the regeneration of bone marrow
hematopoietic cells, thereby supporting the recovery of blood cell
production. By this mechanism of action, PLX-R18 could potentially
treat a broad range of hematologic indications.
Incomplete Recovery Following
HCT
Hematopoietic cell transplantation (HCT) is a
standard treatment for a range of conditions, including malignant
diseases such as multiple myeloma, non-Hodgkin’s lymphoma,
Hodgkin’s disease, and acute myeloid leukemia, as well as
non-malignant diseases and autoimmune disorders such as aplastic
anemia and thalassemia. The hematopoietic cells for HCT can come
from a donor (allogeneic) or from the patient (autologous), and can
be harvested from peripheral blood, bone marrow or umbilical cord
blood.
In a number of cases, complete hematopoietic
recovery following HCT is not reached, and patients are at
increased risk of bleeding, infection, anemia, and poor general
function. Current treatments include administration of factors
stimulating growth of specific blood cell types, such as
granulocyte-colony stimulating factor (G-CSF),
granulocyte-macrophage colony-stimulating factor (GM-CSF), and
erythropoietin. However, a significant number of patients do not
respond to growth factors and may require frequent transfusions,
which expose them to transfusion-related risks such as
allo-sensitization and infections, without providing a curative
solution. These are also associated with significant costs.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of placenta-based cell therapy products. The Company has
reported robust clinical trial data in multiple indications for its
patented PLX (PLacental eXpanded) cells. The cells release a range
of therapeutic proteins in response to inflammation, ischemia,
hematological disorders, and radiation damage. PLX cell products
are grown using the Company's proprietary three-dimensional
expansion technology. They are off-the-shelf, requiring no tissue
matching prior to administration.
Pluristem has a strong intellectual property
position; Company-owned and operated, GMP-certified manufacturing
and research facilities; strategic relationships with major
research institutions; and a seasoned management team.
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, we are using forward-looking
statements when we discuss the expected timing for enrollment for
the Phase I trial, when we discuss the planned trial design and its
endpoints, when we discuss the potential of positive clinical data
to support further development of PLX-R18 to increase the success
rates of transplants, and when we discuss the potential of PLX-R18
to treat a broad range of hematologic indications. These
forward-looking statements and their implications 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; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, 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; our products may wind up being more
expensive than we anticipate; results in the laboratory may not
translate to equally good results in real clinical settings;
results of preclinical studies may not correlate with the results
of human clinical trials; 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 risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
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