TEL AVIV, Israel, Sept. 5, 2017 /PRNewswire/ -- Cellect
Biotechnology Ltd. (NASDAQ: APOP), a developer of stem cells
selection technology, announced today that the U.S. Food and
Drug Administration (FDA) has granted orphan drug designation
for Cellect's ApoGraft™ for the prevention of acute and chronic
graft versus host disease(GvHD) in transplant patients.
GvHD is a transplant associated disease representing an outcome
of two immune systems crashing into each other. In many
transplantations from donors, and especially in Bone Marrow
Transplantations (BMT), the transplanted immune mature cells (as
opposed to stem cells) attack the host (patient receiving the
transplant) and create severe morbidity and in many cases even
death.
This disease happens as a result of current practices being
unable to separate the GvHD causing cells from the much needed stem
cells. Cellect's ApoGraft™ was designed to eliminate immune
responses in any transplantation of foreign cells and tissues.
Cellect's AppoGraft technology can be utilized already today to
help thousands of development and research centers globally engaged
in adult stem cells based therapeutics by providing them with a
simplified and cost efficient enriched stem cells for use as a raw
material for a wide range of stem cells based therapeutics
R&D. Before Cellect's ApoGraft, such procedures were
extremely complex, inefficient and required substantial resources
in both cost, time and infrastructure requirements. ApoGraft can
now be used to significantly advance the use of stem cells across
multiple therapeutics indications as well as research and
biobanking purposes.
The FDA Orphan Drug Act provides incentives for companies to
develop products for rare diseases affecting fewer than 200,000
people in the United States.
Incentives may include tax credits related to clinical trial
expenses, an exemption from the FDA user fee,
FDA assistance in clinical trial design and potential market
exclusivity for seven years following approval.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: "APOP", "APOPW") has developed a
breakthrough technology for the selection of stem cells from
any given tissue that aims to improve a variety of stem cell
applications.
The Company's technology is expected to provide pharma
companies, medical research centers and hospitals with the tools to
rapidly isolate stem cells in quantity and quality that will allow
stem cell related treatments and procedures. Cellect's technology
is applicable to a wide variety of stem cell related treatments in
regenerative medicine and that current clinical trials are aimed at
the cancer treatment of bone marrow transplantations.
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 Company's pathway for commercialization of its
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: 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; 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 Annual
Report on Form 20-F for the fiscal year ended December 31, 2016 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 period filings with the
SEC and the Tel-Aviv Stock Exchange.
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+972-9-974-1444
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SOURCE Cellect Biotechnology Ltd.