PHOENIX - Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) has announced the U.S. Food and Drug Administration's Orphan Drug Designation for its immunotherapy product, CELZ-101, also known as ImmCelzTM. This designation is a key step for the company's therapy aimed at preventing allograft rejection in pancreatic islet cell transplantation for patients with brittle Type 1 diabetes.
CELZ-101 utilizes a patient's own regulatory T cells (Tregs) in a novel way to potentially reduce the need for lifelong immunosuppression. It is designed to expand and enhance the functionality of Tregs to combat the autoimmune and alloimmune responses that can destroy insulin-producing cells.
Timothy Warbington, CEO of Creative Medical Technology Holdings, stated that this FDA recognition aligns with the company's commitment to addressing the challenges faced by those with brittle Type 1 diabetes. Dr. Courtney Bartlett, Director of Clinical Development, added that CELZ-101 is a significant advancement in cell-based immunotherapy, aiming to achieve operational tolerance in islet cell transplantation.
The Orphan Drug Designation by the FDA is significant as it provides benefits to support the therapy's development, including tax advantages, user fee exemptions, and the potential for market exclusivity upon approval. The company is focused on advancing CELZ-101 through regulatory pathways to transform the treatment options for patients requiring islet transplantation.
Creative Medical Technology Holdings is a biotechnology firm that stands at the forefront of regenerative medicine, developing therapies for various medical needs. The company continues to leverage the body's natural regenerative capabilities to create innovative health solutions.
The information in this article is based on a press release statement from Creative Medical Technology Holdings, Inc.
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