PHOENIX, March 23, 2023 /PRNewswire/ -- Creative
Medical Technology Holdings, Inc. (NASDAQ: CELZ), a
biotechnology company working to revolutionize care through the
development of potentially best-in-class regenerative therapeutics,
today announced that it filed an application with the U.S. Food and
Drug Administration (FDA) to receive Orphan Drug Designation (ODD)
for the treatment of Brittle Type 1 Diabetes using its
ImmCelz®(CELZ-100) platform.
The ImmCelz® (CELZ-100) immunotherapy product
utilizes the Company's cell-free system which has previously
been validated to supercharge the patient's own cells to treat a
number of immune disorders. Currently there is no FDA
approved therapy for a definitive cure of Brittle Type 1 Diabetes.
Human islet cell transplantation has been tried in Brittle Type 1
Diabetes patients and is currently under U.S. FDA review; however,
it requires immunosuppression which has many potential concerns and
complications.
The FDA's Office of Orphan Drug Products grants orphan status to
support the development of medicines for rare disorders that affect
fewer than 200,000 people in the U.S. Orphan drug designation
provides certain benefits, including market exclusivity upon
regulatory approval, if received, exemption of FDA application
fees, and tax credits for qualified clinical trials.
"Human islet cell transplantation is a relatively new procedure
used in people with difficult to control brittle diabetes. Patients
who receive an islet transplant take medication that suppresses
their immune system and prevents rejection of the islet tissue. In
spite of the strengths of the current immunosuppression regimen, it
has failed to enhance single-donor success rates, and the majority
of patients require two or more islet transplants to achieve
insulin independence. As such, there is an impetus to move away
from the use of immunosuppressive therapy and instead shift toward
developing immune therapies such as ImmCelz® to fight
against transplant rejection and autoimmunity. The need for
life-long, high-dose immunosuppression is also associated with
substantial side effects, and continues to limit application of
islet transplantation to manage brittle diabetes," said
Courtney Bartlett, DNP – Director of
Clinical Operations.
ImmCelz® therapy, when co-administered with islet
cells (PHPI), is a promising approach to overcoming transplant
rejection in patients with brittle diabetes. Regulatory T cells, or
Tregs, play a critical role in maintaining immune tolerance and
suppressing alloreactive T cells and innate immune cells that
contribute to islet transplant rejection. Several preclinical and
clinical studies have demonstrated the efficacy and safety of
immune therapy in promoting islet transplant survival, and it
offers several advantages over other immunosuppressive
therapies.
"We are very excited with the possibility that our
ImmCelz® platform can be utilized to help patients with
Type 1 Brittle Diabetes. The filing of our ODD application further
demonstrates our team's ability to accelerate development and
implementation of our immune therapies. We look forward to
working with our clinicians and new collaborators who want to make
an impact on moving away from immunosuppression and its
complications," said Timothy
Warbington, CEO.
The use of the ImmCelz® platform with human Islet
cell transplantation has been assigned its own designation as
CELZ-101. This product within the ImmCelz® platform is
unique in terms of production, scalability and efficacy.
About ImmCelz
ImmCelz®, which is protected
by trade secrets and published U.S. patents, utilizes adult stem
cells derived from qualified donors to endow specific properties to
the patient's immune cells. After the patient's harvested cells are
incubated with the Company's cell-free reprogramming "cocktail",
the cells are re-injected back into the patient. These
"supercharged" cells subsequently "educate" other cells of the
immune system to stop attacking the body, while preserving the
ability to attack foreign pathogens thus providing
immune-optimization. The Company plans to advance multiple
indications for ImmCelz® including for Type I diabetes,
heart disease, liver disease, and kidney disease.
Brittle Diabetes, An Orphan (Rare) Disease
In 2022,
the number of patients in the US with T1D (type 1 diabetes) is
approximately 1.6 million as per the JDRF statistics
(https://www.jdrf.org/t1d-resources/about/facts/). Awareness of
hypoglycemia (low blood sugar) is impaired in 30% of patients with
T1D and recurrent severe hypoglycemia is reported in 66% of these
patients. Episodes of severe hypoglycemia place the patients' lives
and the lives of others at risk (for example, a subject driving a
vehicle at the time of the hypoglycemic episode). Assuming
there are 1.25 million people with T1D in the US, 375,000 are
expected to have impaired awareness of hypoglycemia, 247,500 are
expected to have recurrent severe hypoglycemia, and it is estimated
that about 28% of them will fail to improve, despite access to a
"Specialist Hypoglycemia Service". Thus, less than 74,250 people
would not be responsive to interventions such as
hypoglycemia-focused educational and behavioral programs and
diabetes technologies.
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, gynecology and orthopedics and is traded on
NASDAQ under the ticker symbol CELZ. For further information about
the Company, please
visit www.creativemedicaltechnology.com.
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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