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Receives Israeli Ministry of Health Approval to Initiate Phase I/II

Key Takeaway: Receives Israeli Ministry of Health Approval to Initiate Phase I/II Clinical Trial in Leukemia Patients innovative cell selection product may dramatically reduce bone marrow transplantation risks enrollment expected to begin in the next few weeks Tel Aviv, Israel - September

Full Press Release Details

Receives Israeli Ministry of Health Approval to Initiate Phase I/II
Clinical Trial in Leukemia Patients
innovative cell selection product may dramatically reduce bone marrow
transplantation risks
enrollment expected to begin in the next few weeks
Tel Aviv, Israel - September 13, 2016 -
Cellect Biotechnology Ltd. (Nasdaq: APOP, TASE: APOP), a developer of innovative technology which enables the functional selection
of stem cells, today announced that the Company has received the Israeli Ministry of Health's approval to begin a Phase I/II clinical
trial in leukemia patients. The trial, which Cellect expects will be initiated in a few weeks, is planned to be conducted in the
bone marrow transplantation ("BMT") unit of Rambam Hospital, and led by Clinical Assistant Professor, Zila Zuckerman,
the Director of the unit.
This trial is the first of its kind in leukemia patients in
need of BMT, and will evaluate Cellect's cell selection technology, "Powered by Cellect", with the aim of assessing the
technology's safety and efficacy. Cellect's cell selection process is designed to prevent severe adverse effects resulting
from mature cells, including patient death. These adverse effects occur due to the interaction between the donor's immune system
and the recipient's immune system. Cellect's technology may enable controlled destruction of those mature immune system cells,
thereby preventing the adverse effects.
Dr. Shai Yarkoni, the Company's Chief Executive Officer,
noted: "We are excited to have the opportunity to initiate this clinical trial and look forward to beginning to recruit patients
shortly. The comprehensive preparations, which included extensive studies in healthy volunteers, demonstrated an impressive success
in bone marrow transplants, with neither adverse effects nor mortality. We believe Cellect's transformative approach to cell
selection represents a significant breakthrough in the ability to produce selective destruction of mature cell populations, thus
reducing the significant risks associated with BMT."
The approval granted by the Ministry of Health to conduct the
trial in leukemia patients may facilitate other clinical trial approvals in additional indications in both the US and Europe, which
the Company is currently pursuing. Once the safety of Cellect's cell selection technology is established in clinical trials,
it will be validated for use in other applications, such as stem cell research and manufacturing processes of stem cell-based therapies.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv
Stock Exchange (NASDAQ: "APOP", TASE: "APOP"). The Company develops an innovative technology which enables
the functional selection of stem cells based on their sensitivity to apoptosis. This functional-based selection is a breakthrough
technology in the ability to isolate stem cells from any given tissue, and may improve a variety of stem cells applications.
The Company's first planned product line is expected to
include unique containers for cell selection in an apoptosis-inducing microenvironment. Cellect's first planned commercial
product candidate is a medical kit designed for the cancer treatment bone marrow transplantations market, as well as other markets
which require cell selection. The Company plans that in the future its technology will be integrated in many production procedures
of stem cell-based products.
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 the recruitment of patients for the Phase I/II clinical trial, the ability
of the Company's cell selection process to prevent adverse effects, the potential for the Company's technology to
improve the use of BMT for other indications, the Company's belief that the successful outcome of the Phase I/II clinical
trial will establish proof of concept and validate the usability of its products and the description of its technology and its
proposed uses in other applications. 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. 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; and the Company's 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 prospectus dated July 29, 2016 filed with the SEC, which is available on the SEC's website, www.sec.gov.
Cellect Biotechnology Ltd.
Ronen Twito, Chief Financial Officer and Deputy Chief Executive
Bob Yedid, Managing Director
Last updated: Sep 13, 2016