Research & Development
Creative Medical Technology files FDA Orphan Drug Designation application for ImmCelz(CELZ-100) platform to treat Brittle Type 1 Diabetes
24 March 2023 -

Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a US-based biotechnology company, announced on Thursday that it has filed an application with the US Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for ImmCelz(CELZ-100) platform intended to treat Brittle Type 1 Diabetes.

The ImmCelz (CELZ-100) immunotherapy product utilises 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.

The company said that 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. The use of the ImmCelz platform with human Islet cell transplantation has been assigned its own designation as CELZ-101.

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 US 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.



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