Creative Medical Technology Reports Positive One-Year Results for AlloStem™ Type 2 Diabetes Program

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) has announced promising one-year follow-up data from its AlloStem™ (CELZ-201) Type 2 Diabetes pilot study. The trial demonstrated an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported.

The study involved 20 patients, split equally between CELZ-201 treatment and optimized medical therapy. The treatment utilized the same infusion procedure approved for the company's FDA-cleared Type 1 Diabetes clinical trial. CELZ-201 is an off-the-shelf, universal allogenic cell line developed by the company.

Based on these results, Creative Medical Technology plans to advance AlloStem's development for late-stage Type 2 Diabetes treatment and explore additional therapeutic applications to expand their pipeline, which includes CELZ-201 for early-stage Type 1 Diabetes and CELZ-101 for brittle Type 1 Diabetes.

Positive

• 80% efficacy rate in reducing insulin dependency
• No serious adverse effects reported in clinical trial
• Successful validation of treatment procedure
• Potential expansion of treatment applications

Negative

• Small sample size of only 20 patients in pilot study

Significant Efficacy and No Serious Adverse Effects Observed with CELZ-201

PHOENIX, Feb. 11, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced promising one-year follow-up data from the AlloStem ™ (CELZ-201) Type 2 Diabetes pilot study for late-stage patients. CELZ-201 is an off the shelf, ready-to-use universal and proprietary allogenic (donor) cell line developed by the Company.

Results demonstrate that CELZ-201 achieved an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported.

The study, which included 20 patients—10 receiving CELZ-201 and 10 undergoing optimized medical therapy—validated the safety and efficacy of CELZ-201 through the same infusion procedure used in the Company’s U.S. FDA-cleared Type 1 Diabetes clinical trial, which is currently underway. The absence of safety concerns further supports the potential of CELZ-201 as a breakthrough treatment for late-stage Type 2 Diabetes.

Given these compelling results, Creative Medical Technology plans to advance the development of AlloStem (CELZ-201) for the treatment of late-stage Type 2 Diabetes and explore other potential applications of this therapy to expand the Company’s pipeline.

"The positive one-year data from the study represents a significant milestone in our mission to revolutionize diabetes treatment and help a wide variety of patients who potentially may not benefit from autologous therapies," said Timothy Warbington, President and CEO of Creative Medical Technology. "With a diversified portfolio that includes CELZ-201 for early-stage Type 1 Diabetes, CELZ-101 for brittle Type 1 Diabetes, and CELZ-201 for late-stage Type 2 Diabetes, we are committed to delivering innovative solutions that transform patient care."

About Type 2 Diabetes*
Type 2 diabetes affects approximately 90-95% of the 38 million Americans diagnosed with diabetes. While initially managed through diet, exercise, and oral medications, many patients eventually require insulin therapy as the disease progresses. Diabetes remains the eighth leading cause of death in the U.S., with over 96 million adults classified as prediabetic—more than 80% of whom are unaware of their condition.

*https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html

About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company dedicated to developing groundbreaking regenerative cell therapies. The company’s pipeline targets a range of conditions, with a focus on endocrinology, immunotherapy, orthopedic and neurological diseases. For more information, visit www.creativemedicaltechnology.com.

Forward Looking Statements
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.

Contact:
Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com

Investor Relations:
Devin Sullivan, Managing Director
The Equity Group Inc.
dsullivan@equityny.com

FAQ

What were the one-year results of CELZ's AlloStem Type 2 Diabetes trial?

The one-year results showed an 80% overall efficacy rate in reducing insulin dependency and stabilizing hemoglobin A1c levels, with no serious adverse effects reported in the 20-patient pilot study.

How many patients participated in CELZ's AlloStem Type 2 Diabetes study?

The study included 20 patients total, with 10 receiving CELZ-201 treatment and 10 undergoing optimized medical therapy.

What is CELZ-201's current development status for Type 2 Diabetes?

Following positive one-year results, Creative Medical Technology plans to advance CELZ-201's development for late-stage Type 2 Diabetes treatment and explore additional applications.

What other diabetes treatments is CELZ developing besides AlloStem for Type 2 Diabetes?

CELZ is developing CELZ-201 for early-stage Type 1 Diabetes and CELZ-101 for brittle Type 1 Diabetes, alongside CELZ-201 for late-stage Type 2 Diabetes.