Pluri’s PLX-R18 Increases Blood Cell Counts and Reduces Need for Transfusions in a Phase I Study: Results Published in Nature Bone Marrow Transplantation
2023年8月16日 - 8:00PM
Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”),
a leading biotech company that transforms cells into solutions that
promote wellbeing and sustainability, today announced the
publication of an article titled “Placental expanded
mesenchymal-like cells (PLX-R18) for poor graft function after
hematopoietic cell transplantation: A phase I study” in the peer
reviewed journal Nature Bone Marrow Transplantation.
As described in the article, in a successful
Phase I first-in-human study which achieved its primary endpoint,
patients with incomplete hematopoietic recovery post-hematopoietic
cell transplantation (HCT) were treated with escalating doses of
Pluri’s cell therapy, PLX-R18. While patients received only two
administrations of PLX-R18 during the first week, as compared to
the standard of care which requires frequent and ongoing dosing,
treated patients showed increased blood cell counts for as long as
12 months from administration, and a reduction in the need for
blood transfusions. PLX-R18 was well tolerated with a favorable
safety profile.
PLX-R18, a placental-derived cell therapy, has
been granted Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of graft failure, incomplete
hematopoietic recovery following HCT, and the treatment of ARS.
Low levels of blood cells (cytopenia) post-HCT
can persist despite adequate engraftment of donor cells. Pluri’s
PLX-R18 cells secrete a large array of hematopoietic factors which
promote regeneration, maturation, and differentiation of
hematopoietic cells and stimulate their migration to peripheral
blood.
Dr. Joseph P. McGuirk, lead author of the
published study and Schutte-Speas Professor, Hematologic
Malignancies and Cellular Therapeutics at the University of Kansas
Medical Center, commented, “This study suggested that PLX-R18 was
able to increase blood cell counts and reduce the need for
transfusions regardless of whether or not patients received
hematopoietic growth factors, strengthening our conclusion that it
was indeed PLX-R18, and not the other medications given to the
patients, which contributed to the demonstrated efficacy. PLX-R18
shows promise in improving incomplete hematopoietic recovery
post-HCT and has potential in other condition where cytopenia is a
problem, for example, after CAR-T therapy.”
Pluri’s Chief Medical Officer Nitsan Halevy
added, “These results reinforce PLX-R18’s role as a potent
potential therapy for hematological disorders, encompassing its
proposed application in treating acute radiation syndrome. The
publication of these findings in the esteemed Nature BMT journal,
along with the backing of NIAID, significantly bolsters our H-ARS
program and advances us toward the goal of marketing authorization.
As a groundbreaking, first-in-class solution, PLX-R18’s capacity to
augment hematopoietic system recovery and effectively manage
diverse cytopenia holds immense promise.”
About Pluri Inc.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 wellbeing 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 initiatives — 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
field of regenerative medicine, food-tech and biologics and aims to
establish partnerships that leverage the Company’s 3D cell-based
technology to additional industries that require effective, mass
cell production. To learn more, visit us at www.pluri-biotech.com
or follow us on LinkedIn and 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 potential benefits of PLX-R18, that PLX-R18 shows
promise in improving incomplete hematopoietic recovery post-HCT and
has potential in other condition where cytopenia is a problem, that
the study results reinforce PLX-R18’s role as a potent potential
therapy for hematological disorders and advances it toward the goal
of marketing authorization. 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: Nathan Miller at
nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com
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