Pluristem to Present First Cohort Data from PLX-R18 Hematological Study at American Society of Hematology’s (ASH) Annual Me...
November 28 2018 - 8:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
regenerative medicine company developing novel placenta-based cell
therapy products, today announced that the company will present
data from the first cohort of its Phase I study of PLX-R18 cells
for the treatment of incomplete hematopoietic recovery following
hematopoietic cell transplantation (HCT) at the American Society of
Hematology’s (ASH) 60th Annual Meeting to be held in San Diego,
California, on December 1-4, 2018.
About the study
A Phase I study of PLX-R18 cells to treat
incomplete hematopoietic recovery following HCT is ongoing in U.S.
and Israel. The trial is designed as a multi-center, open-label,
dose-escalating study to evaluate the safety of intramuscular
injections (IM) of PLX-R18 cells in 24 subjects with incomplete
hematopoietic recovery persisting for at least 4 months after HCT.
The 24 patients in the study will be enrolled into three treatment
groups: two administrations of 1 million PLX-R18 cells (n=3), two
administrations of 2 million PLX-R18 cells (n=6), two
administrations of 4 million PLX-R18 cells (n=15). The primary
endpoint will be safety which will be assessed at the end of each
cohort by an external safety committee. There will also be
exploratory endpoints, including changes in platelet and hemoglobin
levels, changes in transfusion frequency, a shift from transfusion
dependence to transfusion independence, changes in quality of life,
and changes in the serum immunological parameters.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine
company developing novel 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. PLX cell products 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; 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. The
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
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pluristem Therapeutics (NASDAQ:PSTI)
Historical Stock Chart
From Apr 2023 to Apr 2024