Pluristem Presents Data from First Cohort in Ongoing Phase I Hematological Study at the American Society of Hematology (ASH) ...
December 03 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing novel placenta-based cell therapy products, today
announced that the Company presented data from the first cohort of
patients in its ongoing Phase I clinical trial of PLX-R18 for the
treatment of incomplete hematopoietic recovery following
hematopoietic cell transplantation (HCT) at the American Society of
Hematology (ASH) 60th Annual Meeting and Exposition, which is being
held December 1-4 in San Diego.
The poster, titled “Prospective, Multi-Center,
Phase I Clinical Trial of PLX-R18 Placental Expanded Adherent
Stromal Cells in Subjects with Incomplete Hematopoietic Recovery
after Hematopoietic Cell Transplantation,” summarizes findings from
the first cohort of three patients in the Company’s Phase I
clinical study which is ongoing in the U.S. and Israel. Patients
were administered two doses of PLX-R18 one week apart via
intramuscular (IM) injections at the lowest of three doses to be
evaluated (1 million PLX-R18 cells/kg). The treatment was found to
be safe and well tolerated, with no unexpected toxicities. All
safety data had been reviewed by an external safety committee and
based on the safety presented to them study was approved to move
forward. In addition, early signals of efficacy in improving blood
counts were observed. As previously announced in September 2018,
the PLX-R18 cell therapy for the treatment of incomplete
hematopoietic recovery following HCT was granted Orphan Drug
Designation by the U.S. Food and Drug Administration.
“We are pleased that the first cohort in this
important study met its primary objective of safety, and are
encouraged by the early signals of efficacy that we observed, even
at the lowest dose in patients suffering from serious hematological
condition failing to reach hematopoietic recovery,” commented Zami
Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “We
are now enrolling the second cohort of patients to be evaluated at
an intermediate dose of two million cells per kilogram, and we look
forward to additional data as we continue to advance this promising
regenerative cell therapy through clinical development.”
This Phase I study is designed as a
multi-center, open-label, dose-escalating study to evaluate the
safety of IM injections of PLX-R18 cells in 24 patients with
incomplete hematopoietic recovery persisting for at least four
months after HCT. The follow up period is 12 months. The patients
in the study will be enrolled into three chronological treatment
groups: two administrations of 1 million PLX-R18 cells/kg (n=3),
two administrations of 2 million PLX-R18 cells/kg (n=6) and two
administrations of 4 million PLX-R18 cells/kg (n=15). The primary
endpoint is safety which is assessed, at the end of each cohort, by
an external Data Safety Monitoring Board. In addition, exploratory
evaluations are made, 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
TherapeuticsPluristem 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. For
example, Pluristem is using forward-looking statements when it
discusses the timing and plans relating to its clinical trials, the
safety of PLX-R18 in the clinical trial and the early signals of
efficacy in improving blood counts observed in the clinical trial.
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:
Efrat KaduriHead of Investor and Public
Relations972-74-7108600efratk@pluristem.com
Karine Kleinhaus, MD, MPH Divisional VP, North
America 1-914-512-4109
karinek@pluristem.com
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