Creative Medical Technology Holdings Engages Highly Respected International CRO for Phase 1 / 2 Clinical Trial to Treat Type 1 Diabetes Using CELZ-201
March 07 2023 - 8:00AM
Business Wire
CELZ-201 is the First Novel Allogenic
Cellular Therapy in the Dorsal Artery of the Pancreas in the United
States
Creative Medical Technology Holdings, Inc. ("Creative Medical
Technology Holdings" or the "Company") (NASDAQ: CELZ), a
biotechnology company working to revolutionize care through the
development of potentially best-in-class regenerative therapeutics,
today announced that it has engaged Syneos Health (NASDAQ: SYNH) as
the contract research organization (CRO) for its upcoming Phase 1/2
randomized, controlled clinical trial for the treatment of Type 1
Diabetes using the Company’s CELZ-201 cell therapy. The objective
of the study, which is expected to commence during the first
quarter of 2023, is to determine the safety and efficacy of
CELZ-201 administration.
This engagement follows the Company’s recent announcements
regarding the receipt of Institutional Review Board approval to
proceed with this clinical trial (February 2023) and clearance by
the U.S. Food and Drug Administration of its Investigational New
Drug application for CELZ-201 to treat Type 1 Diabetes (November
2022).
The Company believes that CELZ-201 leverages a unique approach
to harnessing the power of Perinatal Tissue Derived Cells® (PRDC)
to multi-potentialities, including self-renewal ability, low
antigenicity, reduced toxicity, without immunosuppression and with
large-scale clinical expansion.
“The commencement of this first-in-country clinical trial is a
milestone event for Creative Medical Technology Holdings and a
reflection of our commitment to developing novel therapies with the
potential to address areas of high unmet medical need,” said
Timothy Warbington, CEO of Creative Medical Technology Holdings,
Inc. “We are very pleased to have engaged Syneos Health, which
brings a wealth of experience, insight, and know-how in the
advancement of important therapies such as CELZ-201.”
Mr. Warbington concluded, “We remain supported in our efforts by
a talented and dedicated team of employees and collaborators, and a
strong financial position that provides us with the resources to
drive our clinical development initiatives.”
About Type 1 Diabetes
As of 2019, there were 1.6 million adults aged 20 years or older
diagnosed with Type 1 Diabetes (T1D) in the United States. The
economic burden caused by T1D amounts to approximately $14.4
billion in medical costs and lost income, and there are currently
limited treatment options beyond insulin. T1D results from the
autoimmune destruction of insulin-producing islet cells in the
pancreas, leading to loss of insulin production and impairment of
blood glucose control. The absence of insulin leads to
abnormalities in how the body processes nutrients, leading to high
blood glucose levels. High blood glucose can lead to diabetic
ketoacidosis and over time, to complications such as kidney
disease/failure, eye disease (including vision loss), heart
disease, stroke, nerve damage and even death. Due to the
limitations and complexities of insulin delivery systems, it can be
difficult to achieve and maintain balance in glucose control in
patients with T1D. Hypoglycemia remains a critical limiting factor
in glycemic management, and severe hypoglycemia can cause loss of
consciousness, coma, seizures, injury, and can be fatal.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a biotechnology
company dedicated to the advancement of identifying and translating
novel biological therapeutics in the fields of immunotherapy,
endocrinology, urology, neurology, and orthopedics and is traded on
NASDAQ under the ticker symbol CELZ. For further information about
the Company, please visit www.creativemedicaltechnology.com.
Special Note Regarding Forward Looking Statements
NASDAQ Markets has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release. This
news release may contain forward-looking statements including but
not limited to comments regarding the timing and content of
upcoming clinical trials and laboratory results, marketing efforts,
funding, etc. Forward-looking statements address future events and
conditions and, therefore, involve inherent risks and
uncertainties. Actual results may differ materially from those
currently anticipated in such statements. See the periodic and
other reports filed by Creative Medical Technology Holdings, Inc.
with the Securities and Exchange Commission and available on the
Commission's website at www.sec.gov.
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version on businesswire.com: https://www.businesswire.com/news/home/20230306005698/en/
Company Contact Creative Medical Technology
IR@CreativeMedicalTechnology.com
Investor Relations Devin Sullivan, Managing Director The
Equity Group Inc. dsullivan@equityny.com
David Shayne, Analyst dshayne@equityny.com
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