U.S. FDA Clears Pluristem’s IND to Treat Victims Exposed to Acute Radiation
May 02 2018 - 9:15AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that the U.S. Food and Drug Administration (FDA) has cleared the
Company’s Investigational New Drug (IND) application for its
PLX-R18 cell therapy in the treatment of acute radiation syndrome
(ARS). The IND allows Pluristem to treat victims who may have been
acutely exposed to high dose radiation due to nuclear attack or
accident. With this IND in place, Pluristem will now start the
necessary preparations in order to keep an emergency stock of
PLX-R18 on hand for use in such events.
The U.S. National Institutes of Health’s
National Institute of Allergy and Infectious Diseases (NIAID)
sponsored and completed a successful Phase II-equivalent study of
PLX-R18 in the treatment of ARS via the FDA’s animal rule pathway.
PLX-R18 is also being studied by the U.S. Department of Defense
(DOD) to support the needs of the armed forces and study PLX-R18 as
a treatment prior to, or within the first 24 hours of, radiation
exposure. Pluristem is currently in discussions with the FDA and
several U.S. governmental agencies to clear the path for its
proposed pivotal study of PLX-R18 in ARS.
Per the IND protocol, PLX-R18 will be provided
up to 96 hours following radiation exposure. The approved dosage
for treatment in humans is 4 million cells per kilogram, the
optimal dosage that was determined in the Phase II-equivalent
non-human primate pilot study. PLX-R18 cells demonstrated a
dramatic increase in survival of population exposed to high dose of
radiation and enhancement of blood lineages recovery.
“We are proud to have PLX-R18 join the exclusive
club of IND approved medical countermeasures for the treatment of
ARS. This FDA clearance is one of the most significant milestones
in the development of PLX-R18 to date and should provide Pluristem
with significant support in advancing its off-the-shelf cell
therapy into a pivotal trial. The fact that we are now able to
treat human casualties in the case of a nuclear event provides us
with the ability to protect from severe health consequences, saving
lives of population in need,” stated Pluristem Chairman and Co-CEO
Zami Aberman.
About ARSAcute Radiation Syndrome occurs
following acute exposure to very high levels of radiation, and
involves severe, potentially lethal injury to the bone marrow as
well as to other organs and systems within the body. High doses of
radiation can destroy the bone marrow’s ability to produce white
blood cells, red blood cells and platelets; without these cells
patients are at high risk of death.
About PLX-R18PLX-R18 is
Pluristem’s second cell therapy product in development. It is
designed to treat bone marrow that is unable to produce enough
blood cells due to a variety of causes including ARS, certain
cancers or cancer treatments, or immune-mediated bone marrow
failure. PLX-R18’s first animal studies in ARS were performed in
collaboration with Prof. Gorodetsky at Hadassah Medical Center.
Further preclinical data from trials conducted by the U.S. National
Institutes of Health, Hadassah, the Charité in Berlin and other
prominent research institutions, have shown that PLX-R18 cells
secrete a range of specific proteins that salvage and trigger the
regeneration of bone marrow hematopoietic cells, thereby supporting
the recovery of blood cell production. With its capabilities,
PLX-R18 could potentially be used in several indications to treat a
broad range of hematologic disorders, which together constitute a
substantial global market. Pluristem is currently enrolling
patients in a multinational Phase I trial of PLX-R18 in incomplete
bone marrow recovery following hematopoietic cell
transplantation.
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 cells and is entering late-stage trials in several
indications. Our PLX cell products release a range of therapeutic
proteins following intramuscular administration, in response to
inflammation, ischemia, muscle trauma, hematological disorders, and
radiation damage. The cells are grown using the Company's
proprietary three-dimensional expansion technology and can be
administered to patients off-the-shelf, without tissue matching.
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 express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, Pluristem is using forward-looking statements when its
discusses its intention to keep an emergency stock of PLX-R18 on
hand for use in a nuclear event, its proposed pivotal study of
PLX-R18 in ARS, its belief that the approved IND may provide it
with the potential to help populations in need as well as support
its ARS program and its belief that the IND approval will provide
it with significant support in advancing its off-the-shelf cell
therapy into a pivotal trial. 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;
Pluristem may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; Pluristem’s products
may not be approved by regulatory agencies, Pluristem’s technology
may not be validated as it progresses further and its methods may
not be accepted by the scientific community; Pluristem may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with Pluristem’s process; Pluristem’s
products may wind up being more expensive than it anticipates;
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; Pluristem’s
patents may not be sufficient; Pluristem’s products may harm
recipients; changes in legislation may adversely impact Pluristem;
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:
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
efratk@pluristem.com
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