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PHOENIX - Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotech firm engaged in regenerative medicine with a market capitalization of $5.3 million, announced today that the FDA has authorized an expanded dose escalation for its Phase 1/2 StemSpine® trial. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet. The trial investigates the use of AlloStem™, an allogeneic cell therapy for chronic lower back pain due to degenerative disc disease. Interim data from the trial has shown significant pain reduction and improved mobility in participants, with no serious adverse events reported thus far. The company’s stock has shown resilience, posting a 31.17% gain year-to-date despite broader market challenges.
The FDA’s clearance permits the company to enhance dosing strategies to potentially improve therapeutic outcomes. The Data Safety Monitoring Board and the Institutional Review Board have approved this new dosing regimen, which is already being implemented in the study. With the company’s next earnings report due on March 24, 2025, InvestingPro subscribers can access additional insights and financial metrics to track the company’s progress.
The ongoing trial utilizes a 4:1 treatment-to-placebo ratio and is conducted in an outpatient setting using a minimally invasive ultrasound-guided injection. The positive interim findings suggest that CELZ-201-DDT could represent a non-opioid breakthrough for the treatment of chronic back pain. The company’s CEO, Timothy Warbington, expressed that the FDA’s approval to expand dosing could accelerate the progression towards a Phase 3 trial and a future Biologics License Application submission. The company’s current share price of $3.03 reflects market optimism about these developments.
Creative Medical Technology Holdings is committed to developing regenerative therapies for pain management, neurology, and urology. CELZ-201-DDT is designed to address the pathology of degenerative disc disease without the need for surgery or exposure to radiation.
Enrollment for the clinical trial continues as planned, with final data anticipated to influence subsequent clinical and regulatory strategies. This news is based on a press release statement from Creative Medical Technology Holdings, Inc.
In other recent news, Creative Medical Technology Holdings, Inc. has secured $3.7 million through the exercise of warrants, facilitated by Roth Capital Partners. The company plans to use these funds for working capital and general corporate purposes. In a significant development, Creative Medical also reported promising results from its AlloStem™ (CELZ-201) Type 2 Diabetes pilot study, showing an 80% efficacy rate in reducing insulin dependency. Furthermore, Creative Medical has entered into a strategic collaboration with Greenstone Biosciences Inc. to incorporate Artificial Intelligence in enhancing its stem cell platform for diabetes treatment. This partnership aims to optimize cell function and reduce the need for immunosuppression in therapies.
Additionally, Creative Medical has increased its authorized shares of common stock from 5 million to 25 million, following stockholder approval. This decision was made during a Special Meeting of Stockholders, where the full exercise of previously issued warrants was also approved. These developments reflect Creative Medical’s ongoing efforts to advance its regenerative medicine initiatives and expand its financial and operational capabilities.
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