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APOP - Cellect Biotechnology News Story

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Cellect Biotechnology Initiates U.S. Clinical Trial of ApoGraft

Thu 22nd October, 2020 1:00pm
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Tel Aviv, Israel , Oct. 22, 2020 (GLOBE NEWSWIRE) -- Cellect Biotechnology
Ltd. (NASDAQ: "APOP"), a developer of innovative technology which enables the
functional selection of cells facilitating safer and more efficacious cell and
gene therapies, today announced that it has initiated its clinical trial in
the U.S. to determine the safety and tolerability of the ApoGraft technology
for bone marrow transplantations (BMT).  The trial will enroll 18 patients
and the primary end point of the study is overall incidence, frequency and
severity of adverse events potentially related to ApoGraft at 180 and 360 days
from transplantation.

This is the second clinical trial of ApoGraft.  The first trial in Israel has
enrolled eleven patients, and the dose level of the final cohort is identical
to the dose level used in the U.S. trial. The Company has previously disclosed
interim data showing that the trial unequivocally met the safety and
tolerability end point, and the Company expects to publish top line data in
early 2021.

“This is a pivotal development for Cellect, and it demonstrates a
significant step forward as we embark on our first-ever U.S. clinical trial
for ApoGraft,” commented Dr. Shai Yarkoni, Chief Executive Officer. 
“Although the COVID-19 pandemic impacted our expected commencement and
timelines, I am encouraged by the work of our team and collaborators as they
navigated all the pandemic constraints after the U.S. Investigational New Drug
(IND) approval. We plan to leverage our collaborators’ support and expertise
to seek out further indications and regulatory approvals for other indications
of cell therapy where ApoGraft may be used. This is an exciting period for
Cellect, and we are pleased to begin treating patients in this trial in the
coming weeks.”

The trial will be conducted by bone marrow transplantation specialists at
Washington University School of Medicine, a leading academic institution based
in St. Louis, Missouri and is co-sponsored by the university and Cellect.
  ApoGraft cell selection technology is designed to prevent
graft-versus-host disease (GVHD) following bone marrow transplantation. This
is an open label phase 1 clinical trial of eighteen patients and is designed
to evaluate the safety and tolerability of the ApoGraft process in patients
with hematological malignancies who are undergoing a haploidentical
hematopoietic stem cell transplantation (HSCT).

The Principal Investigator for the clinical trial is Zhifu Xiang, M.D., of
Washington University. He is an Associate Professor in the Division of
Oncology's Bone Marrow Transplantation & Leukemia Section in the Department of
Medicine. In addition, Mark Schroeder, M.D., and John DiPersio M.D., Ph.D.,
will act as co-Principal Investigators for the study. Dr. DiPersio is the
chief of the Division of Oncology in the Department of Medicine at Washington
University. The collaboration is led by Dr. DiPersio, who also is Director of
the Center for Gene and Cellular Immunotherapy, Washington University School
of Medicine, and a past president of the American Society for Blood and Marrow

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology and line
of products, for the functional selection of cells. The Company is in clinical
development of its lead product – the ApoGraft™ - improving Bone Marrow
Transplantations (BMT) outcome.

The Company’s technology aims to improve the robustness, safety and efficacy
of a variety of cell and gene therapies and therefore can be used by
researchers, clinical community and pharma companies in a wide variety of
applications including next generation CAR-T, NK, MSC and gene therapies. 
During human clinical trials, the Company has previously disclosed that
interim data has unequivocally met safety and tolerability end point, further
validating ApoGraft.

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 commencement of its planned
U.S. clinical trial and its plan to reduce operating costs. 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;
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, 2019 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.
Eyal Leibovitz, Chief Financial Officer


EVC Group LLC  
Michael Polyviou
(732) 933-2754


GlobeNewswire, Inc. 2020
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