Pluristem Announces End of Patient Enrollment in its Phase I Hematology Study
August 19 2020 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological therapeutic products,
announced today it has completed patient enrollment in its Phase I
study evaluating PLX-R18 as a treatment for incomplete
hematopoietic recovery following hematopoietic cell transplantation
(HCT), in the U.S. and in Israel.
Incomplete hematopoietic recovery poses a
significant risk 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.
The Phase I multi-center, open-label, 3 cohort
dose-escalating study is evaluating the safety of intramuscular
(IM) injections of PLX-R18 cells in 20 subjects, with incomplete
hematopoietic recovery persisting for at least 3 months after HCT.
The follow up period is 12 months. Safety is the primary endpoint,
with efficacy endpoints including changes in white blood cells,
platelets counts, hemoglobin levels, changes in blood products
requirements, and changes in quality of life. As previously
reported, Pluristem expects to announce top line efficacy results
during the first quarter of calendar year 2021.
“We are glad to meet an additional important
clinical milestone that keeps us on track for our expected time to
readout, and is one of four data readouts we expect to announce in
the coming twelve months. We look forward to seeing data that may
position PLX-R18 as an important drug candidate for hematological
disorders. We would like to thank the medical teams across the
clinical sites supporting our program in the most professional and
caring way,” stated Pluristem CEO and President, Yaky Yanay.
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 the expected timing of
the top line results for its Phase I study and other readouts and
the ability of PLX-R18 to address unmet needs in patients by
stimulating the regenerative potential of the bone marrow. 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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