Type 1 Diabetes Cell Therapy Cleared to Begin Clinical Trial

Creative Medical Technology Holdings’ AlloStem, an investigational cell therapy based on Perinatal Tissue Derived Cells (PRDC), has received clearance of its investigational new drug (IND) application from the FDA for evaluation in the treatment of type 1 diabetes.¹

Allostem is intended to incorporate advantages of PRDC including “self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion.” It will be evaluated in the CELZ-201 clinical trial for patients with newly diagnosed type 1 diabetes, which the company expects will begin recruiting patients in the first quarter of next year. Camillo Ricordi, MD, Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami in Florida, will serve as the national principal investigator for CELZ-201.

"This is a milestone event for Creative Medical Technology Holdings as it marks the Company's first IND clearance from the FDA," Timothy Warbington, chief executive officer, Creative Medical Technology Holdings, said in a statement regarding the news.¹ "We are excited to commence this trial under the guidance of one of the world's most respected diabetes clinical researchers and at a renowned research institute... We are also excited to announce the use of our proprietary AlloStem product in this study, as we believe it validates our efforts in creating assets that support our approach to developing immunotherapies. With this IND clearance, we are accelerating our efforts to identify novel biologics and develop therapies with the potential to effectively treat unmet needs of patients. I wish to acknowledge our team and collaborators for their hard work and dedication to this program. "

AlloStem is not the company’s only cell therapy candidate being investigated for the treatment of type 1 diabetes. In January 2021, the company filed a patent for ImmCelz, a cell therapy product produced from patient-derived cells that have been reprogrammed with factors secreted from universal donor stem cells, for the treatment of type 1 diabetes.^2,3 At the same time the company announced positive preclinical data for the treatment, including results from studies which showed that ImmCelz reduced incidence of diabetes in a non-obese diabetic model and reversed diabetes in several mice. Dosing was also associated with increases in the production of VEGF, EGF, IGF, and HGF. Additional preclinical studies, results from which were announced in June 2021, showed that Immcelz administered along with myeloid suppressor cells was capable of suppressing autoimmune diabetes. Immcelz is also under preclinical investigation for the treatment of heart disease, liver disease, and kidney disease, and an IND has been filed for Immcelz in the treatment of stroke.⁴

"The ongoing influx of positive experimental data supports the notion that ImmCelz is a promising therapeutic platform that has ability to address many unmet medical needs associated with degeneration and inflammation," Warbington said in a January 2021 statement.³ "Our vision is that one day ImmCelz will be for degenerative diseases what CAR-T cells were for hematology."

REFERENCES

1. Creative Medical Technology Holdings announces FDA clearance of investigational new drug (IND) application for Allostem™, a novel cell therapy for the treatment of type 1 diabetes. News release. Creative Medical Technology Holdings, Inc. November 3, 2022. https://creativemedicaltechnology.investorroom.com/2022-11-03-Creative-Medical-Technology-Holdings-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-AlloStem-TM-,-a-Novel-Cell-Therapy-for-the-Treatment-of-Type-1-Diabetes

2. Creative Medical Technology Holdings identifies synergy between Immcelz® regenerative immunotherapy and myeloid suppressor cells in treatment of type 1 diabetes. News release. Creative Medical Technology Holdings, Inc. June 9, 2021. https://creativemedicaltechnology.investorroom.com/2021-06-09-Creative-Medical-Technology-Holdings-Identifies-Synergy-Between-ImmCelz-R-Regenerative-Immunotherapy-and-Myeloid-Suppressor-Cells-in-Treatment-of-Type-1-Diabetes

3. Creative Medical Technology Holdings announces positive data and patent filing using Immcelz® to treat type 1 diabetes. News release. Creative Medical Technology Holdings, Inc. January 19, 2021. https://creativemedicaltechnology.investorroom.com/2021-01-19-Creative-Medical-Technology-Holdings-Announces-Positive-Data-and-Patent-Filing-Using-ImmCelz-R-to-Treat-Type-1-Diabetes

4. Pipeline. Creativemedicaltechnology.com. (n.d.). Retrieved November 4, 2022, from https://creativemedicaltechnology.com/#ourpipeline