Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft v...
October 13 2020 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological products, today announced
that it has received clearance from the safety committee of an
investigator initiated Phase I/II study to move forward with
patient enrollment for cohort II. The study will evaluate PLX-PAD
cells in the treatment of steroid-refractory chronic graft vs. host
disease (GvHD) and is led by Principal Investigator Prof. Ron Ram,
Director of the Hematology Blood and Marrow Stem Cell
Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov
Hospital, Israel. Prof. Ram and his research staff are responsible
for the design and implementation of the study at Sourasky Medical
Center.
GvHD is a severe complication in patients who
have undergone an allogeneic hematopoietic cell transplantation
(HCT) and is a major cause of morbidity and mortality in these
patients in which the donated stem cells identify the recipient's
body as foreign and attack it. The chronic form of GvHD (cGvHD)
usually appears later than 100 days post-transplant.
Cohort I included 6 patients treated with 2
injections of 150 million cells, a week apart. At the 3-month
follow up, interim safety results concluded that PLX-PAD cells were
safe and that no treatment related side effects were reported.
Efficacy results demonstrated that 4 out of the 6 patients reported
improvement in symptoms that translated into a reduction in the
severity of cGvHD with notable reduction in the required steroid
doses for part of the patients. Based on these results, the study
was approved to commence enrollment of 14 patients in cohort II to
be treated with 4 injections of 150 million cells.Prof. Ram of
Ichilov Hospital commented, “From our experience in having treated
6 patients in the study to date, we have so far found no negative
side effects from the use of the PLX-PAD cells in the treatment of
steroid-refractory cGvHD. Patients with significant GvHD skin
disorders previously unresponsive to multiple types of therapy
showed remarkable response. Responses were also observed for severe
mouth ulcers which prevented patients from eating solid foods. This
resulted in a major improvement of quality of life and tapering of
steroid doses."
“Pluristem is committed to contributing to the
wellbeing and quality of life of our patients. cGvHD is an
indication where we see a significant need to enhance the current
course of treatment for this life-threatening condition among
patients undergoing bone marrow transplants. The preliminary
results from cohort I of this Phase I/II study, and prior
preclinical data, both indicate that PLX-PAD cells may potentially
treat cGvHD patients and mitigate symptoms. We are very pleased to
cooperate with Prof. Ram and Sourasky Medical Center, and we place
a high importance in examining PLX-PAD for this indication,” stated
Pluristem CEO and President, Yaky Yanay.
About
cGvHDChronic graft-versus-host
disease (cGvHD) remains a common and potentially life-threatening
complication of allogeneic hematopoietic stem cell transplantation
(HCT). The 2-year cumulative incidence of chronic GvHD
requiring systemic treatment is ∼30% to 40% by National Institutes
of Health criteria1. The hematopoietic stem cell transplants are
used to treat bone marrow failure resulting from treatment of some
blood or bone marrow cancers as well as other hematologic failures,
such as aplastic anemia, which are not related to cancer. The
donated cells identify the recipient’s body as foreign and attack
it as a result. While acute GvHD usually appears in the first 100
days after a transplant, and in specific body systems, chronic GvHD
can occur at any time (even several years) after a transplant, and
may manifest in many parts of the body such as: skin, mouth, eyes,
liver, intestines, lungs and joints. Long term immunosuppression is
given to try to prevent or treat cGvHD. Since this treatment
suppresses the immune system for a very long time, patients are at
high risk of infections, and are prescribed multiple medications to
try to address this major risk.
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 patient enrollment
for cohort II for its Phase I/II study of its PLX-PAD cells, the
implication from the results of the first patient cohort in the
study, the belief that GvHD is an indication that has a significant
need for enhanced treatments among patients undergoing bone marrow
transplants and that the preliminary results from cohort I of the
study, and the prior preclinical data, indicate that PLX-PAD cells
may potentially treat chronic GvHD patients and mitigate symptoms.
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
_________________________________
1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host
disease. Blood. 2015 Jan 22;125(4):606-15. doi:
10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933;
PMCID: PMC4304105., https://pubmed.ncbi.nlm.nih.gov/25398933/
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