Full Press Release Details
Cellect Biotechnology Announces Positive
Outcome from Safety Review Committee;
Successfully Transplants 9th Clinical Trial Patient
progress as Washington University's Scientific Review Committee Approved the Company's First U.S. Study
TEL AVIV, Israel - August 12, 2019
- 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
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
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.
Cellect Biotechnology Ltd.
Dr. Shai Yarkoni, Chief Executive Officer