Type 1 diabetes (T1D) affects approximately 1.6 million people in the US, and the majority of T1D patients with recurrent severe hypoglycemia have impaired awareness of hypoglycemia. Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a biotechnology company that translates novel biological therapeutics in fields such as immunotherapy, endocrinology, urology, gynecology, and orthopedics. The company’s dedication to novel biologic therapeutics could significantly benefit patients with T1D who experience recurrent hypoglycemia. ImmCelz therapy, combined with islet cells, offers a promising solution to transplant rejection in patients with brittle diabetes. The company has filed an application with the U.S. Food and Drug Administration to receive Orphan Drug Designation (ODD) for the treatment of Brittle Type 1 Diabetes using its ImmCelz platform. With its expertise in immunotherapy, Creative Medical Technology Holdings could potentially develop a treatment that addresses the root cause of T1D, reducing the risk of hypoglycemia and improving patients’ quality of life.
Creative Medical Technology Holdings, Inc. has submitted an application to the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its ImmCelz®(CELZ-100) platform. The treatment aims to treat Brittle Type 1 Diabetes, a rare disorder affecting fewer than 200,000 people in the U.S. Orphan drug designation provides benefits such as market exclusivity upon regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials.
ImmCelz® (CELZ-100) is a cell-free system that utilizes the patient’s own cells to treat a range of immune disorders. Human islet cell transplantation is currently under FDA review as a potential treatment for Brittle Type 1 Diabetes, but it requires immunosuppression, which has many potential complications.
According to Courtney Bartlett, DNP – Director of Clinical Operations, the need for life-long, high-dose immunosuppression is associated with substantial side effects and continues to limit the application of islet transplantation to manage brittle diabetes. In contrast, ImmCelz® may provide a solution to transplant rejection and autoimmunity, potentially revolutionizing care for this disorder.
The ImmCelz® platform may offer a significant advancement in the treatment of Brittle Type 1 Diabetes. The application for Orphan Drug Designation is a crucial step in the process towards regulatory approval, with market exclusivity and other benefits providing an incentive for companies to invest in rare disease treatments.
ImmCelz® therapy, combined with islet cells (PHPI), offers a promising solution to transplant rejection in patients with brittle diabetes. Immune therapy has demonstrated the efficacy and safety of promoting islet transplant survival through the use of regulatory T cells (Tregs), which maintain immune tolerance and suppress immune cells responsible for transplant rejection. ImmCelz® has several advantages over other immunosuppressive therapies and offers a new solution to treating Type 1 Brittle Diabetes.
The filing of the Orphan Drug Designation (ODD) application for the ImmCelz® platform further demonstrates Creative Medical Technology’s ability to develop and implement new immune therapies quickly. The CEO, Timothy Warbington, is enthusiastic about the potential for the ImmCelz® platform to make an impact in moving away from immunosuppression and its complications.
CELZ-101, a product within the ImmCelz® platform, uses human islet cell transplantation and has unique properties in terms of production, scalability, and efficacy.
ImmCelz® utilizes adult stem cells from qualified donors to enhance specific properties in the patient’s immune cells, offering a unique approach to immune-optimization. The Company plans to advance multiple indications for ImmCelz®, including Type I diabetes, heart disease, liver disease, and kidney disease.
Brittle Diabetes, a rare disorder affecting fewer than 200,000 people in the U.S., can benefit from ImmCelz® therapy, potentially revolutionizing the treatment of this orphan disease.
Type 1 diabetes (T1D) affects approximately 1.6 million people in the US, according to JDRF statistics. Thirty percent of T1D patients have impaired awareness of hypoglycemia (low blood sugar), and 66% of them have recurrent severe hypoglycemia, which endangers their lives and those of others, such as while driving. Even with access to a “Specialist Hypoglycemia Service,” about 28% of patients fail to improve, leaving fewer than 74,250 individuals who may be unresponsive to interventions such as educational and behavioral programs and diabetes technologies.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a biotechnology company that translates novel biological therapeutics in fields such as immunotherapy, endocrinology, urology, gynecology, and orthopedics. The company is committed to revolutionizing patient care, with a focus on addressing the unmet medical needs of patients with rare diseases.
The company’s dedication to novel biologic therapeutics could significantly benefit patients with T1D who experience recurrent hypoglycemia. With its expertise in immunotherapy, Creative Medical Technology Holdings could potentially develop a treatment that addresses the root cause of T1D, reducing the risk of hypoglycemia and improving patients’ quality of life.
Creative Medical Technology Holdings trades on NASDAQ under the symbol CELZ. The company’s forward-looking statements in this news release, including the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc., must be taken with a grain of salt as actual results may differ materially from those currently anticipated. The Securities and Exchange Commission’s website at www.sec.gov contains the periodic and other reports filed by Creative Medical Technology Holdings, Inc.
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