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

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) announced FDA clearance of its Investigational New Drug (IND) application for AlloStem™, the first allogenic cellular therapy targeting Type 1 Diabetes (T1D) in the U.S. This milestone allows for the initiation of clinical trials (CELZ-201), expected to begin patient recruitment in Q1 2023. AlloStem™ utilizes Perinatal Tissue Derived Cells, offering potential benefits in treating T1D, which currently affects 1.6 million Americans. The company is committed to developing innovative immunotherapies to address unmet medical needs.

Positive

• FDA clearance for IND application of AlloStem™ enables clinical trials for Type 1 Diabetes.
• AlloStem™ leverages a novel approach using Perinatal Tissue Derived Cells for treatment.

Negative

• None.

AlloStem™ represents the first novel allogenic cellular therapy in the dorsal artery of the pancreas in the United States 

PHOENIX, Nov. 3, 2022 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), an immuno-endocrine company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug (IND) application, enabling the Company to proceed with initiating a clinical trial for Type 1 Diabetes using AlloStem™.

AlloStem™ leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells^® (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The primary objective of the study (CELZ-201) is to evaluate AlloStem™ in patients with newly diagnosed Type 1 Diabetes. Patient recruitment is expected to begin in Q1 2023 with trial commencement updates to follow.

The national principal investigator of the study is Camillo Ricordi, M.D. Dr. Ricordi is the 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, where he serves as the Director of the Diabetes Research Institute and the Cell Transplant Program.  

Dr. Ricordi will give an update on the study today at the 8th Perinatal Stem Cell Society Congress/Workshop at 9:00am EST.

"This is a milestone event for Creative Medical Technology Holdings as it marks the Company's first IND clearance from the FDA," said Timothy Warbington, CEO.  "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."

Mr. Warbington continued, "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."

About Type 1 Diabetes
As of 2019, there were 1.6 million adults aged 20 years or older diagnosed with Type 1 Diabetes (T1D) in the United States. The economic burden caused by T1D amounts to approximately $14.4 billion in medical costs and lost income, and there are currently limited treatment options beyond insulin. T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal.

About Creative Medical Technology Holdings                                                                                            
Creative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, neurology and orthopedics and is traded on NASDAQ under the ticker symbol CELZ. For further information about the Company, please visit www.creativemedicaltechnology.com. 

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.

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SOURCE Creative Medical Technology Holdings, Inc.

FAQ

What is the significance of the FDA clearance for Creative Medical Technology Holdings' AlloStem™?

The FDA clearance allows Creative Medical Technology Holdings to initiate clinical trials for AlloStem™, targeting Type 1 Diabetes, marking a pivotal advancement in their research.

When is the patient recruitment for the AlloStem™ clinical trial expected to begin?

Patient recruitment for the AlloStem™ clinical trial is expected to begin in Q1 2023.

What is AlloStem™ being evaluated for?

AlloStem™ is being evaluated for its efficacy in treating patients with newly diagnosed Type 1 Diabetes.

Who is leading the clinical trial for AlloStem™?

The national principal investigator for the AlloStem™ clinical trial is Dr. Camillo Ricordi from the University of Miami.

What are the potential benefits of AlloStem™ for Type 1 Diabetes patients?

AlloStem™ may provide a novel treatment option that addresses the limitations of current therapies for Type 1 Diabetes.