Cellect Biotechnology Initiates U.S. Clinical Trial of ApoGraft
October 22 2020 - 8:00AM
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 Transplantation.
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.
ContactCellect Biotechnology
Ltd.Eyal Leibovitz, Chief Financial
Officerwww.cellect.co+972-9-974-1444
Or
EVC Group LLC Michael Polyviou(732)
933-2754mpolyviou@evcgroup.com
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