TEL AVIV, Israel, May 11, 2020 /PRNewswire/ -- Cellect
Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative
technology which enables the functional selection of stem cells,
today announced the publication of an article in Bone Marrow
Transplantation, a peer-reviewed medical journal
)member of the Nature publishing house) covering
transplantation of bone marrow in humans and published monthly by
the prestigious Nature Research, entitled 'Ex-vivo
FAS-ligand to Improve Allograft Safety'. The article is
co-authored by researchers at Cellect and its academic
partners.
The paper highlights the pre-clinical research and demonstrates
that engraftment is robust following transplantation of treated
graft, and the graft retains its immune reconstitution and
anti-leukemic effects. The Company has initiated a Phase 1/2 study
in adults undergoing stem cell transplant for the treatment of
hematological malignancies. The primary endpoint of the study is to
evaluate the overall incidence, frequency, and severity of adverse
events potentially related to ApoGraft™ at 180-days
post-transplant. All patients transplanted through present
time using the ApoGraft™ process were engrafted and time to
engraftment was similar to the standard of care. To date, there
have not been any safety and tolerability concerns during the study
and patient enrollment is continuing. Both, the principal
investigator (PI) and independent data safety monitoring board
(DSMB) agree that no serious adverse events (SAEs) reported during
the course of the study were related to the ApoGraft™
process.
The data from the pre-clinical research, and published in this
paper, was included in the Company's Investigational New Drug (IND)
application, which was approved by the U.S. Food and Drug
Administration in late 2019. The Company has received all the
necessary approvals to initiate the trial with its academic
partner, Washington University, and
plans to begin patient recruitment once the COVID-19 pandemic is
mitigated and clinics can resume normal practices.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: APOP) has developed a
breakthrough technology, for the selection of stem cells from any
given tissue, that aims to improve a variety of stem cell-based
therapies.
The Company's technology is expected to provide researchers,
clinical community and pharma companies with the tools to rapidly
isolate stem cells in quantity and quality allowing stem cell-based
treatments and procedures in a wide variety of applications in
regenerative medicine. The Company's current clinical trial is
aimed at bone marrow transplantations in cancer treatment.
Forward Looking Statements
This press release contains forward-looking statements about the
Company's expectations, beliefs and intentions. Forward-looking
statements can be identified by the use of forward-looking words
such as "believe", "expect", "intend", "plan", "may", "should",
"could", "might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. For
example, forward-looking statements are used in this press release
when we discuss Cellect's expectations regarding timing of the
commencement of its planned U.S. clinical trial and its plan to
reduce operating costs. These forward-looking statements and their
implications are based on the current expectations of the
management of the Company 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.
In addition, historical results or conclusions from scientific
research and clinical studies do not guarantee that future results
would suggest similar conclusions or that historical results
referred to herein would be interpreted similarly in light of
additional research or otherwise. The following factors, among
others, could cause actual results to differ materially from those
described in the forward-looking statements: the Company's history
of losses and needs for additional capital to fund its operations
and its inability to obtain additional capital on acceptable terms,
or at all; the Company's ability to continue as a going concern;
uncertainties of cash flows and inability to meet working capital
needs; the Company's ability to obtain regulatory approvals; the
Company's ability to obtain favorable pre-clinical and clinical
trial results; the Company's technology may not be validated and
its methods may not be accepted by the scientific community;
difficulties enrolling patients in the Company's clinical trials;
the ability to timely source adequate supply of FasL; risks
resulting from unforeseen side effects; the Company's ability to
establish and maintain strategic partnerships and other corporate
collaborations; the scope of protection the Company is able to
establish and maintain for intellectual property rights and its
ability to operate its business without infringing the intellectual
property rights of others; competitive companies, technologies and
the Company's industry; unforeseen scientific difficulties may
develop with the Company's technology; the Company's ability to
retain or attract key employees whose knowledge is essential to the
development of its products; and the Company's ability to pursue
any strategic transaction or that any transaction, if pursued, will
be completed. Any forward-looking statement in this press release
speaks only as of the date of this press release. The Company
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual
Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities
and Exchange Commission, or SEC, which is available on the SEC's
website, www.sec.gov, and in the Company's periodic filings with
the SEC.
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou
+732-933-2754
mpolyviou@evcgroup.com
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SOURCE Cellect Biotechnology Ltd.