Pluristem to Present Initial Results from Its Phase I HCT Study with PLX-R18 Demonstrating Safety and Efficacy at the ASH Ann...
November 18 2020 - 7:00AM
Pluristem Therapeutics Inc.
(Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological therapeutic products,
today reported the first clinical results for PLX-R18 in humans
from its Phase I study evaluating PLX-R18 as a treatment for
incomplete hematopoietic recovery following hematopoietic cell
transplantation (HCT). The initial results consisted of the
analysis of the first 19 patients enrolled, and not all patients
completed a one year follow up.
The initial data from the Phase I trial
demonstrated:
- The treatment
with PLX-R18 was found to be safe and well-tolerated.
- An overall
improvement was observed in most patients, with the high-dose
cohort showing clinically meaningful improvements from baseline to
9-month in hemoglobin (Hb); absolute neutrophil count (ANC) a
measure of white blood cells; and platelet count (PLT). In this
cohort, Hb levels increased from 9.29±0.5 to 13.19±1.2 (p=0.0019),
ANC increased from 1.09±0.6 to 5.13±1.7 (p=0.018) and PLT increased
from 45.7±10 to 175.9±28 (p=0.000012).
Incomplete hematopoietic recovery poses a
significant life-threatening condition to HCT recipients who fail
to respond to standard of care treatments, making them vulnerable
to infections and bleeding. PLX-R18 may address the unmet need in
this patient population by stimulating the regenerative potential
of bone marrow where other treatments have proven ineffective. The
U.S. Food and Drug Administration (FDA) has granted Orphan Drug
Designation to PLX-R18 in this indication.
A presentation titled “Safety and Demonstrated
Efficacy of Placenta-Derived Cell Therapy PLX-R18 in Subjects with
Incomplete Hematopoietic Recovery Following Hematopoietic Cell
Transplantation: A Phase I International Multi-Center Study” will
be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine,
Case Western Reserve University, and Member of the study's Steering
Committee at the virtual 62nd ASH Annual Meeting and Exposition on
December 5, 2020.
Prof Hillard M. Lazarus commented on the
results, “The use of Pluristem’s PLX-R18 product candidate in a
group of patients who had extremely low blood counts resulted in
actual clinical improvement with a significant rise in critical
blood counts.”
Pluristem CEO and President Yaky Yanay stated,
“These first PLX-R18 data in humans support our expectations that
our PLX platform can yield multiple regenerative therapeutics. This
significant milestone adds to a pivotal year ahead with four
readouts in Critical Limb Ischemia (CLI), muscle regeneration
following hip fracture, COVID-19 complicated by Acute Respiratory
Distress Syndrome (ARDS), and HCT evaluating both our PLX-PAD and
PLX-R18 product candidates. We are committed to developing
solutions for unmet medical needs based on our expertise attained
over a decade and supported by our advanced platform technology and
in-house manufacturing capabilities.”
The ASH Annual Meeting is the world’s most
comprehensive hematology event of the year featuring scientific
abstracts highlighting updates on the most critical topics in
hematology. With more than 18,000 members from nearly 100
countries, ASH is the world's largest professional society serving
both clinicians and scientists around the world who are working to
conquer blood diseases.
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy product candidates. The Company has reported robust
clinical trial data in multiple indications for its patented PLX
cell product candidates and is currently conducting late stage
clinical trials in several indications. PLX cell product candidates
are believed to release a range of therapeutic proteins 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; a
Company-owned and operated GMP-certified manufacturing and research
facility; strategic relationships with major research institutions;
and a seasoned management team.
Safe Harbor StatementThis 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 it discusses its Phase I HCT study,
expected timing for reporting top line results from the full
clinical study, its anticipation for a significant year with four
readouts in CLI, muscle regeneration following hip fracture,
COVID-19 complicated by ARDS, and HCT evaluating both our PLX-PAD
and PLX-R18 product candidates, that these first PLX-R18 data in
humans support its expectations that its PLX platform can yield
multiple regenerative therapeutics or when it discusses developing
solutions for unmet medical needs. 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:Dana RubinDirector of Investor
Relations972-74-7107194danar@pluristem.com
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