Creative Medical Technology Holdings, Inc. Receives FDA Orphan Drug Designation for CELZ-101 in Key Transplantation Therapy
06 Marzo 2024 - 1:00PM
Business Wire
Creative Medical Technology Holdings, Inc. (NASDAQ:
CELZ), a leader in the field of regenerative medicine with a
focus on developing novel therapies in immunotherapy,
endocrinology, urology, gynecology, and orthopedics, is pleased to
announce the successful receipt of Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) for CELZ-101, ImmCelzTM.
This cutting-edge therapy is aimed at preventing allograft
rejection in patients undergoing pancreatic islet cell
transplantation, a significant advancement for individuals dealing
with brittle Type 1 diabetes, a condition characterized by extreme
fluctuations in blood glucose levels.
CELZ-101, also known as Supercharged Treg Biologic Immunotherapy
(ImmCelzTM), represents a state-of-the-art approach in personalized
medicine, utilizing the patient's own regulatory T cells (Tregs) to
combat autoimmune and alloimmune responses that can destroy
insulin-producing cells. This innovative therapy is based on a
proprietary process that not only expands Tregs but also enhances
their functionality, offering a promising solution to reduce the
need for lifelong immunosuppression.
Timothy Warbington, CEO of Creative Medical Technology Holdings,
stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores
our commitment to developing groundbreaking therapies. This
important milestone propels us closer to offering a lasting
solution for those grappling with the everyday hurdles of brittle
Type 1 diabetes, marked by erratic fluctuations in glucose levels.
It harmonizes with our mission to better patients' lives through
the forefront of regenerative medicine. "
Dr. Courtney Bartlett, DNP, AGACNP-BC, CCRP, Director of
Clinical Development, commented, "The development of CELZ-101 is a
major step forward in the realm of cell-based immunotherapy. It
addresses the critical need for more effective treatments in
brittle Type 1 diabetes by aiming for operational tolerance in
islet cell transplantation, potentially freeing patients from the
burden of lifelong immunosuppression. We believe this is the first
orphan designated, synergistic cell-based immunotherapy for brittle
Type 1 diabetes."
“The Orphan Drug Designation by the FDA highlights CELZ-101's
potential to meet a significant unmet need in the prevention of
allograft rejection during pancreatic islet cell transplantation
which was recently approved by the FDA. This designation provides
multiple important benefits to support the therapy's development
including tax advantages, user fee exemptions, and the opportunity
for market exclusivity following approval,” added Timothy
Warbington, CEO of the Company.
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is
dedicated to progressing CELZ-101 through the necessary regulatory
pathways, with the goal of transforming the therapeutic landscape
for patients in need of islet transplantation. This achievement
underscores the company's dedication to leveraging the natural
regenerative capabilities of the human body to create lasting
health solutions.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is a
biotechnology company dedicated to the advancement of identifying
and translating novel, immediately deployable FDA registered,
biological therapeutics in the fields of immunotherapy,
endocrinology, urology, gynecology and orthopedics and is traded on
NASDAQ under the ticker symbol CELZ.
Creative Medical Technology Holdings is at the vanguard of
regenerative medicine, focusing on the development and
commercialization of breakthrough therapies for unmet medical
needs. With a robust portfolio of innovative treatments, Creative
Medical Technology Holdings is reshaping the future of healthcare
by marrying advanced scientific research with the body's natural
healing mechanisms.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240306397066/en/
Company Contact Creative Medical Technology
IR@CreativeMedicalTechnology.com Investor Relations Devin
Sullivan, Managing Director The Equity Group Inc.
dsullivan@equityny.com Conor Rodriguez, Analyst
crodriguez@equityny.com
Grafico Azioni Creative Medical Technol... (NASDAQ:CELZ)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni Creative Medical Technol... (NASDAQ:CELZ)
Storico
Da Feb 2024 a Feb 2025