Pluristem Enters into Agreement with Tel Aviv Sourasky Medical Center to Conduct Phase I/II Trial in Steroid-Refractory Chron...
November 06 2017 - 7:00AM
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, today announced
that it has signed an agreement with Tel Aviv Sourasky Medical
Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD
cell therapy for the treatment of Steroid-Refractory Chronic
Graft-versus-Host-Disease (GvHD).
The trial will be an investigator initiated study. As
such, Tel Aviv Sourasky Medical Center will support the study and
will be responsible for its design and implementation. Dr. Ron Ram,
Director of the Hematology Blood and Marrow Stem Cell
Transplantation Unit for the Tel Aviv Sourasky Medical Center will
act as principal investigator.
GvHD is a potentially lethal complication of
hematopoietic cell transplantation (HCT) from a donor. When a
patient receives a donor’s stem cells, the transplanted cells
identify the patient’s body as foreign and attack it. The chronic
form of GvHD occurs at least 100 days following the
transplantation. The GvHD market is predicted to exceed $500
million by 2023.
Preclinical studies showed that Pluristem’s
PLX-PAD cell product potentially mitigates symptoms of GvHD, and in
addition the secretion profile and mechanism of action properties
suggest that it may be a novel and effective treatment for the
condition. Pluristem hopes to address this severe unmet medical
need and help patients lead full lives after undergoing a
transplant.
“We’re excited to work with Pluristem towards
developing an effective treatment for chronic GvHD,” noted Dr. Ron
Ram at the Tel Aviv Sourasky Center. “Our Clinical Research Center
is a hub for groundbreaking treatments and is the perfect testing
ground for Pluristem’s cell therapy.”
“Studies have shown that our PLX cells have
beneficial effects in a number of hematologic indications. We are
very pleased to enter into this collaboration with Tel Aviv
Sourasky Medical Center while continuing to focus on advancing our
lead indications into pivotal and Phase III studies,” said Zami
Aberman, Chairman and Co-CEO of Pluristem. “Our unique, proprietary
technology platform and the versatility of our cells allow us to
develop our cell products to treat a number of conditions with
inadequate treatment options. We look forward to offering new hope
to patients worldwide.”
About Chronic GvHD
Chronic GvHD occurs in approximately 40% of
patients who have received a transplant of hematopoietic stem cells
sourced from the bone marrow or peripheral blood of a donor. These
hematopoietic stem cell transplants are used to treat some blood or
bone marrow cancers as well as other hematologic conditions, 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 chronic GvHD. 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
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 its proposed Phase I/II trial studying Pluristem’s
PLX-PAD cell therapy, the potential for PLX-PAD and Pluristem’s
hopes to address GvHD to help patients lead full lives after
undergoing a transplant. 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, 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
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