Following Approval of Israel’s Ministry of Health, Pluristem Extends its Trial of PLX-R18 to Treat Insufficient Hematopoiet...
October 26 2017 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a
leading developer of placenta-based cell therapy products,
announced today that it received approval from Israel’s Ministry of
Health to initiate a Phase I trial studying the company’s PLX-R18
cell therapy as a treatment for insufficient hematopoietic recovery
following hematopoietic cell transplantation (HCT). As previously
announced, the trial was also approved by the U.S. Food and Drug
Administration (FDA) and recruitment is ongoing in the United
States. Up to 30 patients will be recruited in total from the
United States and Israeli trial sites. Ethics committees at both
Hadassah Medical Center and Rambam Hospital in Israel have cleared
the trial and recruitment can begin in both hospitals.
“We’re very pleased with the Israeli Ministry of
Health’s vote of confidence in our innovative therapies and efforts
to provide treatments for a range of hematopoietic conditions,
including insufficient recovery from hematopoietic stem cell
transplants,” stated Zami Aberman, Pluristem’s Co-CEO and Chairman.
“Hadassah Medical Center and Rambam Hospital are well known for
their groundbreaking treatments and we are happy for this
collaboration. Previous studies with PLX-R18 cells have yielded
promising results, which we believe suggest that our cells can
improve patient outcomes.”
Pluristem’s PLX-R18 cells are in late-stage
development as a treatment for acute radiation syndrome (ARS) and
the program is supported by the U.S. National Institutes of Health
(NIH), which is conducting the trials. The cells are also being
studied by the U.S. Department of Defense and the Fukushima Medical
University in Japan. Pluristem recently reported a new granted
patent to cover PLX-R18 cells in additional indications related to
the bone marrow’s inability to produce blood cells, including
autoimmune diseases, genetic disorders, chemotherapy, and radiation
therapy.
Bone Marrow Failure and HCT
Bone marrow failure is the inability of bone
marrow to produce sufficient numbers of platelets, white or red
blood cells. This inability may result in serious illness or death,
because these cells are necessary to prevent hemorrhage, infection
or severe anemia. Bone marrow failure can be caused either by
medical conditions such as aplastic anemia, myelodysplastic
syndrome, hematologic malignancies, or as a side effect of
radiation or chemotherapy cancer treatment. The incidence of bone
marrow failure resulting from these conditions varies widely, but
is increasing.
The only known cure for bone marrow failure is
HCT, although supportive therapies and treatments can reduce
symptoms and prolong life for some patients. The hematopoietic
cells for HCT can come from a donor or from the patient, and can be
harvested from peripheral blood, bone marrow or umbilical cord
blood. Transplant patients require extensive care and monitoring,
and sometimes need intensive treatment for complications. In cases
of incomplete engraftment, blood cell counts are insufficient,
causing the patient to be at high risk of severe or lethal
complications. In severe cases, the patient may need to undergo the
arduous and dangerous process of a second transplant.
About PLX-R18
PLX-R18 is Pluristem’s second cell therapy
product in development. It is designed to treat bone marrow that is
unable to produce enough blood cells due to a variety of causes
including ARS, certain cancers or cancer treatments, or
immune-mediated bone marrow failure. PLX-R18’s first animal studies
in ARS were performed in collaboration with Prof. Gorodetsky at
Hadassah Medical Center. Further preclinical data from trials
conducted by the NIH, Hadassah, the Charite in Berlin and other
prominent research institutions have shown that PLX-R18 cells
secrete a range of specific proteins that trigger the regeneration
of bone marrow hematopoietic cells, thereby supporting the recovery
of blood cell production. Pluristem is currently enrolling patients
in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow
recovery following HCT and is preparing for a pivotal trial in
ARS.
About Pluristem Therapeutics
Pluristem Therapeutics is a leading developer of
placenta-derived cell therapy products with patented PLX
(PLacental eXpanded) cells entering late-stage trials in several
indications. Our PLX cell products each release a different 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 3D expansion
technology and can be administered to patients without tissue
matching or immunosuppression. Pluristem has Company-owned and
operated, GMP-certified manufacturing and research facilities, a
strong intellectual property position, and strategic relationships
with major research and U.S. government institutions.
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 its
discusses the timing and patient recruitment of its proposed Phase
I trial studying the company’s PLX-R18 cell therapy and its belief
that its cells can improve patient outcomes. 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:
Karine Kleinhaus, MD, MPHDivisional VP, North
America1-914-512-4109karinek@pluristem.com
Efrat KaduriInvestor and Public Relations
Manager972-74-7108600efratk@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