TEL AVIV, Israel, Aug. 12, 2019 /PRNewswire/ -- Following the one
month data of the 9th patient, the Data and Safety
Monitoring Board (DSMB) reviewed the safety data from Cellect
Biotechnology Ltd.'s (Nasdaq: APOP) ongoing Phase 1/2
clinical study of ApoGraft™, and announced that the DSMB
unanimously recommended dose escalation and the continuation of
enrollment for the fourth and final dose cohort in the
study.
At one-month post transplantation, the patient has shown
complete engraftment and has not demonstrated any procedure-related
adverse effects. The Company currently expects to complete the
patient recruitment by the end of 2019 and release data during the
first half of 2020. 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.
In the U.S., the Company moved closer to the U.S. clinical trial
as Washington University's Scientific
Review Committee (SRC) approved the Company's study, with no
comments. This, along with the other milestones that have
been achieved by the Company over the past few months demonstrate
solid progress and the Company is looking forward to working with
its clinical partner and sharing further progress in the coming
months.
"We are increasingly pleased with our global clinical progress,"
commented Dr. Shai Yarkoni, Chief
Executive Officer. "In Israel, the DSMB's recommendation to
proceed to the final cohort of our ApoGraft study without
modification furthers us towards meeting our goal of enrolling the
final three patients by the end of this year, which reaffirms the
positive safety data to date. In the U.S., we are getting closer to
realizing our plans to initiate our first trial in the U.S. as
evidenced by the SRC's recent approval of our study."
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
upcoming clinical program objectives. 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; and 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, 2018 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.
Dr. Shai Yarkoni, Chief Executive
Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou
+1-(732)-933-2754
cellect@evcgroup.com
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SOURCE Cellect Biotechnology Ltd.