Creative Medical Technology Holdings Announces Positive Initial Safety, Tolerability, and Efficacy Data from First Cohort in Phase 1/2 Trial of CELZ-201-DDT for Chronic Back Pain

Rhea-AI Summary

Creative Medical Technology Holdings (NASDAQ: CELZ) has reported positive initial data from the first cohort of its Phase 1/2 clinical trial of CELZ-201-DDT, a stem cell-based treatment for chronic back pain caused by degenerative disc disease (DDD). The first cohort, consisting of 8 treated patients and 2 placebo recipients, completed the study phase successfully with no dose-limiting toxicities or serious adverse events.

The blinded preliminary data indicates promising therapeutic potential in pain relief and functionality improvement. The independent Data Safety Monitoring Board (DSMB) has recommended proceeding to the next cohort as planned. Enrollment for the second cohort is expected in Q1 2025.

Positive

• Successful completion of first cohort with no serious adverse events
• Positive preliminary efficacy signals in pain relief and functionality
• DSMB approval to proceed with next trial phase
• Development of non-opioid therapeutic option for chronic back pain

Negative

• Early-stage trial with patient data (only 10 participants)
• Blinded data only - full efficacy results not yet available

PHOENIX, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative medicine, today announced promising initial data from the first cohort of its ongoing Phase 1/2 clinical trial of CELZ-201-DDT, the Company’s proprietary stem cell-based therapeutic for the treatment of chronic back pain caused by degenerative disc disease (DDD).

The first cohort of 10 participants (8 receiving CELZ-201-DDT and 2 receiving placebo) completed the study phase without any dose-limiting toxicities or serious adverse events. Blinded preliminary data suggest encouraging therapeutic potential in alleviating back pain and restoring functionality. Following a comprehensive safety review, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned.

Key Milestones Achieved:

• Safety Confirmed: CELZ-201-DDT demonstrated an excellent safety profile, with no serious adverse events reported in the first cohort.
• Preliminary Efficacy Signals: Blinded data suggest potential therapeutic benefit in addressing chronic back pain associated with degenerative disc disease.
• DSMB Endorsement: The DSMB approved continuation of the study, validating the safety and integrity of the trial design.
• Next Steps: Enrollment for the second cohort is expected in the current first quarter of 2025, with comprehensive data from subsequent cohorts guiding future clinical and regulatory plans.

“This milestone underscores our commitment to addressing chronic back pain, a debilitating condition with limited effective treatment options,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. “The safety and early signals observed in this trial strengthen our belief that CELZ-201-DDT has the potential to transform the standard of care for patients suffering from degenerative disc disease.”

Advancing Innovation in Regenerative Medicine
Creative Medical Technology Holdings is committed to pioneering regenerative solutions that improve quality of life for patients with chronic and debilitating conditions. CELZ-201-DDT represents the Company’s dedication to leveraging stem cell technology to address the root causes of pain and degenerative conditions, providing patients with a novel, non-opioid therapeutic option.

“Our progress with CELZ-201-DDT highlights our vision to deliver groundbreaking therapies for chronic conditions such as degenerative disc disease,” added Warbington. “We are eager to move forward with the trial and are optimistic about the therapy’s ability to provide long-lasting pain relief and improved functionality for patients.”

About CELZ-201-DDT
CELZ-201-DDT is a proprietary regenerative stem cell-based therapy designed to address chronic back pain caused by DDD. By targeting the underlying causes of DDD, CELZ-201-DDT has the potential to restore disc integrity and reduce pain, providing a novel therapeutic approach to a condition that affects millions of patients. Using an ultrasound guided, non-surgical procedure CELZ-201-DDT is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures.

The Phase 1 / 2 study is designed to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT. The study will enroll 30 individuals suffering from chronic lower back pain.

About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a biotechnology company focused on developing regenerative and stem cell-based therapies for unmet medical needs. Leveraging its proprietary platforms, the Company is advancing a robust pipeline of innovative treatments to improve patient outcomes and revolutionize regenerative medicine. For more information, visit www.creativemedicaltechnology.com.

Forward-Looking Statements
This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements reflect the Company’s current views but are not guarantees of future results.

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

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

FAQ

What are the initial results of CELZ-201-DDT Phase 1/2 trial for chronic back pain?

The initial results show no serious adverse events or dose-limiting toxicities in the first cohort of 10 participants, with promising preliminary data suggesting therapeutic benefits in pain relief and functionality improvement.

How many patients were included in the first CELZ-201-DDT trial cohort?

The first cohort included 10 participants: 8 receiving CELZ-201-DDT treatment and 2 receiving placebo.

When will CELZ begin enrollment for the second cohort of the CELZ-201-DDT trial?

Enrollment for the second cohort is expected to begin in the first quarter of 2025.

What condition is CELZ-201-DDT designed to treat?

CELZ-201-DDT is designed to treat chronic back pain caused by degenerative disc disease (DDD).

What was the DSMB's recommendation for the CELZ-201-DDT trial?

The Data Safety Monitoring Board (DSMB) recommended the trial proceed to the next cohort as planned, validating the safety and integrity of the trial design.