TEL AVIV, Israel, Jan. 4, 2018 /PRNewswire/ -- Cellect
Biotechnology Ltd. (NASDAQ: APOP), a developer of a novel stem cell
selection technology, announced that it has successfully completed
transplantation of the first group of three patients using
Cellect's ApoGraft™ technology in the Company's Phase I/II clinical
trial and that after one month follow-up, all three patients have
demonstrated complete acceptance of the stem cell transplant with
no adverse events related to the study treatment, as determined by
the clinical investigator, and no reported serious adverse events
or suspected unexpected serious adverse reactions.
The Phase I/II, dose escalating, 4-cohort, open label clinical
trial of up to twelve patients is designed to evaluate the
safety, tolerability and efficacy of functionally selected donor
derived mobilized peripheral blood cells that underwent the
Company's ApoGraft™ process and were transplanted into patients
with hematological malignancies in an allogeneic hematopoietic stem
cell transplantation. The primary endpoint of the study is overall
incidence, frequency and severity of adverse events potentially
related to ApoGraft™ at 180 days from transplantation. The Company
plans on recruiting a further three patients for the second cohort
of patients following review of the independent data and safety
monitoring board.
The Company believes that these interim results of ApoGraft
present the first signs of a breakthrough in stem cell
transplantation. The product is transplantable within less than 12
hours from donation through a simple process performed on the
bedside after selective physiological elimination of immune
reaction-causing cells. The ApoGraft transplantation is intended to
result in complete recovery of the patient's immune system with no
related safety concerns in contrast to the significant morbidity or
even death causing standard medical procedure.
Dr. Shai Yarkoni, Cellect's CEO
said, "Our ApoGraft™ technology shows consistently successful
results in the use of stem cell transplants for treating patients
suffering from life-threatening conditions. We see our position
strengthened with each patient treated. We aim for stem cell based
regenerative medicine to become a safe and affordable treatment for
most of mankind's diseases."
Stem cells are the building blocks and raw material of
21st century regenerative medicine enabling a world
where damaged tissues and organs may be replaced and regenerated
rather than fixed with drugs, radiation and surgery. However, up to
50 percent of stem cell transplant procedures, such as bone marrow
transplants and others, result in life-threatening rejection
disease and other immune responses such as
Graft-versus-Host-Disease (GvHD). Cellect's ApoGraft™ technology
aims to turn stem cell transplantations into a simple and safe, yet
cost effective procedure by reducing the associated severe side
effects, such as rejection and many other risks.
About GvHD
Despite improved prophylactic regimens, acute GvHD disease still
occurs in an estimated 25% to 50% of recipients of allogeneic stem
cell transplantation. The incidence of acute or chronic GvHD in
these patients is increasing due to the increased number of
allogeneic transplantations survivors, older recipient age, use of
alternative donor grafts and use of peripheral blood as the source
of stem cells. GvHD accounts for an estimated 15% of deaths and is
considered the leading cause of non-relapse mortality after
allogeneic bone marrow transplantation.
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 research,
hospitals 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 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 aim at making its ApoGraft™ technology a
game changer in stem cell transplantations, Cellect's intent
regarding the effects of the ApoGraft™ transplantation, Cellect's
expectations regarding the implications of the results reported in
this press release, and Cellect's aims and expectations regarding
the future of its ApoGraft™ technology and stem cell based
regenerative medicine. 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 procedures,
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: changes in technology
and market requirements; we may encounter delays or obstacles in
launching and/or successfully completing our clinical trials; our
products may not be approved by regulatory agencies, our technology
may not be validated as we progress further and our methods may not
be accepted by the scientific community; we may be unable to retain
or attract key employees whose knowledge is essential to the
development of our products; unforeseen scientific difficulties may
develop with our process; our products may wind up being more
expensive than we anticipate; 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; our patents may not be sufficient; our
products may harm recipients; changes in legislation; inability to
timely develop and introduce new technologies, products and
applications, which could cause the actual results or performance
of the Company to differ materially from those contemplated in such
forward-looking statements. 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, 2016 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 period filings with the
SEC.
Contact:
Cellect Biotechnology Ltd.
Eyal Leibovitz
Chief Financial Officer
www.cellect.co
+972-9-974-1444
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SOURCE Cellect Biotechnology Ltd.