PHOENIX, AZ / ACCESSWIRE / July 13, 2023 / Creative Medical Technology Holdings, Inc. ("Creative Medical Technology") (NASDAQ:CELZ) recently released an update on their drug pipeline and financial standing going into Q3 2023. The biotechnology company is known for its regenerative approach to immunotherapy, endocrinology, urology, gynecology and orthopedics.
In March of 2023, the company reported that it no longer held any long-term debt, had cash and certificates of deposit of $14.6 million, and working capital of $14.4 million. These numbers and the company's confidence in its drug pipeline lead the board to project that the company will have enough money to meet anticipated operating costs and capital expenditures through 2024. Creative Medical Technology is not pursuing any other sources of funding at this time, which is relatively rare for a company at this stage in development.
Creative Medical Technology has achieved significant milestones in its efforts to develop innovative treatments for type 1 diabetes. In November 2022, the U.S. Food and Drug Administration granted clearance to the company's Investigational New Drug (IND) application, allowing them to initiate a phase 1/2 clinical trial for type 1 diabetes using CELZ-201 (AlloStemTM). This trial, the first of its kind in the country, is a crucial step in evaluating the effectiveness of the treatment.
The company received Institutional Review Board (IRB) approval in February 2023 to proceed with the clinical trial, further underscoring the credibility and ethical integrity of its research. They also announced their collaboration with Syneos Health as the contract research organization for the trial, ensuring the highest standards of quality and expertise in conducting the study.
In March, Creative Medical Technology made another significant announcement regarding the FDA filing for Orphan Drug Designation (ODD) for the treatment of type 1 brittle diabetes. They are combining their innovative ImmCelz® product with islet transplantation to provide targeted treatment. These efforts have the potential to not only benefit type 1 diabetes patients but also expand to other cell and organ transplants, presenting a promising avenue for reducing rejection rates and improving patient outcomes.
The company's discussions with the FDA have instilled confidence in the ImmCelz Program's potential for broad application in various transplant procedures. As a result, Creative Medical Technology is accelerating the development of the ImmCelz program, with plans to file an IND later in the year.
In April 2023, the company announced that the use of CELZ-001 cells on patients with type 2 diabetes showed a significant reduction in insulin requirement. These results are based on follow-up data from patients who received the treatment over six months, which demonstrated an impressive overall efficacy of 93%.
One of the key highlights from the trial is that there were no safety concerns related to the use of CELZ-001. This therapy utilizes the same infusion procedure as the current U.S. FDA-cleared CELZ-201 clinical trial for type 1 diabetes. The lack of safety concerns is a strong indication of the treatment's effectiveness in treating type 2 diabetes, offering patients a viable alternative to traditional insulin therapy.
The patients who received the treatment also demonstrated a considerable decrease in their insulin requirement, which is a key metric for evaluating treatments for diabetes. Creative Medical Technology's CELZ-001 treatment had achieved at least a 50% reduction in insulin requirement in treated patients. These results are a promising development in the ongoing fight against diabetes, and the company is committed to continuing its research to provide patients with effective and safe treatments.
The company also recently announced positive results from a pilot study conducted in May. The study focused on the StemSpine® procedure, which uses a proprietary allogenic (donor) cell called AlloStem to treat chronic lower back pain. This approach is similar to other companies like BioRestorative Therapies, but it seems like Creative Medical Technology is further along in development.
The study data revealed promising outcomes for the treated patients. These patients experienced a significant reduction in narcotic usage by more than 90%, a decrease in pain score of over 80%, and improved functionality measured by a decrease of more than 50% in the Oswestry Score. Importantly, none of the patients required additional treatments or surgical intervention after six months, and there were no safety concerns.
What sets this pilot study apart is that it demonstrated the safety and effectiveness of injecting donor cells around the disc, which has the potential to repair, remodel and improve blood supply in the lower back area. This innovative approach may have a positive impact in addressing chronic lower back pain and could provide a non-surgical alternative for patients, contributing to the alleviation of the current opioid crisis.
The company provided updates on its ImmCelz (CELZ-100) platform, a cell-free system designed to enhance a patient's own cells for treating immune disorders. It reported that independent studies have confirmed the benefits of the ImmCelz platform. ImmCelz requires 75% fewer donor patient cells compared to industry standards, ensuring a more efficient process. The platform also achieves a purity level greater than 95%, surpassing the industry standard of 80%. Additionally, it demonstrated a remarkable over 200% reduction in functional suppression of effector T cells, which are especially problematic for patients with autoimmune conditions. Importantly, the platform consistently yields a high number of functional T regulatory cells.
By reducing the number of donor patient cells required and producing a more effective product, Creative Medical Technology believes that it can reach a larger number of patients, including those who may be more seriously ill.
Lastly, in May 2023, Creative Medical Technology announced a significant achievement in collaboration with Greenstone Biosciences Inc. They successfully developed a human-induced pluripotent stem cell (iPSC) pipeline for the Company's ImmCelz platform. This collaboration, known as the iPScelzTM program, has made it possible to enhance the scalability of the ImmCelz Immunotherapy Platform.
The development of this cell line has numerous benefits for Creative Medical Technology. It is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.
Overall, Creative Medical Technology is making impressive strides in the field of regenerative medicine and has a strong focus on addressing critical medical conditions. Their achievements in obtaining regulatory clearance, securing collaborations and expanding treatment possibilities highlight the company's dedication to improving the lives of patients with various diseases and advancing the field of transplant medicine.
Apex The Equity Group Inc., Devin Sullivan
SOURCE: Creative Medical Technology Holdings, Inc.
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