Pluri Evaluates Readiness for Mass Production of PLX-R18 for Acute Radiation Syndrome Amid Rising Nuclear Threat Concerns
November 25 2024 - 8:30AM
Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”),
a biotechnology company leveraging its proprietary platform for
cell-based solutions to create a collaborative network of ventures,
today announced that it is assessing its readiness to initiate mass
production of PLX-R18, a novel potential treatment for
hematopoietic complications of the acute radiation syndrome (H-ARS)
following exposure to nuclear radiation, in response to heightened
global tensions and escalating nuclear threats, particularly in
Ukraine.
PLX-R18 has shown potential promise in significantly improving
survival and accelerating recovery from H-ARS in preclinical animal
and human studies, conducted with support from leading global
health and U.S. defense agencies. PLX-R18 demonstrated the ability
to stimulate blood cell regeneration and potentially mitigate the
effects of radiation exposure.
H-ARS is caused by exposure to life-threatening amounts of
ionizing radiation, such as those which may occur during a
radiological or nuclear accident, terrorist activities, and/or
warfare. The condition is characterized by a dose-dependent bone
marrow depression, leading to neutropenia, thrombocytopenia,
anemia, and possibly death. The U.S. Food and Drug Administration
(“FDA”) previously approved an Investigational New Drug
application for PLX-R18 for the treatment of H-ARS in the case of
nuclear or radiological or incidents and granted it
Orphan Drug Designation.
Scaling Up Production
Beyond what is required for ongoing clinical studies, the
Company is actively examining the steps required to ramp up
production in the event of increased and urgent global demand.
Pluri’s state-of-the-art manufacturing facility is designed to
handle large-scale production of cellular therapies and could be
mobilized to scale up to mass production, if necessary.
“At Pluri, we stand ready to support communities in need by
leveraging our expertise to respond to global emergencies,” said
Yaky Yanay, Chief Executive Officer and President of Pluri. “That
is why we are evaluating our readiness to scale production if
global circumstances escalate and demand arises. We believe that
our proactive approach will ensure global preparedness.”
About Pluri
Pluri™ is pushing the boundaries of science and engineering to
create cell-based products for commercial use and is pioneering a
biotech revolution that promotes global well-being and
sustainability. The Company’s technology platform, a patented and
validated state-of-the-art 3D cell expansion system, advances novel
cell-based solutions for a range of challenges— from medicine and
climate change to food scarcity, animal cruelty and beyond. Pluri’s
method is uniquely accurate, scalable, cost-effective and
consistent from batch to batch. Pluri currently operates in the
regenerative medicine, foodtech and agtech fields. The Company also
offers Contract Development and Manufacturing Organization
services. Pluri establishes partnerships that are aimed to leverage
the Company’s proprietary 3D cell-based technology across various
industries that require effective, mass cell production. To learn
more, visit us at www.pluri-biotech.com or follow Pluri
on LinkedIn and X (formerly known as
Twitter).
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, Pluri is
using forward-looking statements when it discusses the use of
PLX-R18 as a potential treatment for hematopoietic complications of
H-ARS, that its manufacturing facility’s ability to handle
large-scale production of cell therapies could be mobilized to
scale up to mass production and its belief that its proactive
approach will ensure global preparedness. These forward-looking
statements and their implications are based on the current
expectations of the management of Pluri 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 about Pluri: changes in technology and
market requirements; Pluri may encounter delays or obstacles in
launching and/or successfully completing its clinical trials, if
necessary; its products may not be approved by regulatory agencies,
its technology may not be validated as it progresses further and
its methods may not be accepted by the scientific community; it 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 its processes; its 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; its patents may not be sufficient; its products
may harm recipients or consumers; changes in legislation with an
adverse impact; 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 Pluri to differ materially
from those contemplated in such forward-looking statements. Except
as otherwise required by law, Pluri 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 Pluri
reference is made to Pluri’s reports filed from time to time with
the Securities and Exchange Commission.
Media Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
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