Full Press Release Details
Announces Positive Phase I/II Mid-Study Results of its ApoGraft Technology
Completion of First half of ApoGraft Phase I/II Clinical Trial Shows 100% Engraftment and No Related Adverse Effects
Aviv, Israel March 27, 2019 - Further validating its ApoGraft technology, Cellect Biotechnology Ltd. (Nasdaq:
APOP), a developer of a novel stem cell production technology, announced positive mid-study data from the Company's Phase
I/II study of its ApoGraft technology. The first half of patients planned for the study have completed the 180 day follow
up, and 8 out of 12 planned subjects have been enrolled.
patients transplanted 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 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.
following is the mid-study results overview of the first six patients at 180 days:
are encouraged that the data for the Phase I/II study continues to validate our ApoGraft technology - and the data at this
point fully met our expectations," commented Dr. Shai Yarkoni, Chief Executive Officer. "As we enroll the remaining
patients, we believe the results strengthen our plans to initiate the next trial in the U.S. during the first half of the year
and begin to monetize Cellect's proof of concept as we seek partnerships and collaborations with academics and corporate
Phase I/II, open-label, proof of concept, staggered 4-cohort clinical study is designed to evaluate safety and tolerability of
ApoGraft in patients with haemato-oncology disorders undergoing allogenic HLA-matched hematopoietic stem cell transplant
(HSCT). 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.
Cellect Biotechnology Ltd.
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.
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.
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 intent regarding the future potential of Cellect's
technology. 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. 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,
and in the Company's periodic filings with the SEC.
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
Michael Polyviou / Sarah Scouten, PhD
(732) 933-2754 / (716) 352-7379