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Creative Medical Technology Holdings (NASDAQ: CELZ) has engaged Syneos Health (NASDAQ: SYNH) as the contract research organization for its Phase 1/2 clinical trial of CELZ-201, aimed at treating Type 1 Diabetes. This trial, set to begin in Q1 2023, follows Institutional Review Board approval and FDA clearance for the investigational new drug. CELZ-201 utilizes Perinatal Tissue Derived Cells to potentially address unmet medical needs in diabetes care. The company's CEO highlighted this milestone as a reflection of their commitment to innovative therapies. The economic impact of Type 1 Diabetes in the U.S. is significant, with costs reaching $14.4 billion.
Positive
Engagement of Syneos Health for clinical trial management.
Phase 1/2 trial set to begin in Q1 2023.
FDA clearance for CELZ-201 indicates regulatory progress.
Negative
None.
CELZ-201 is the First Novel Allogenic Cellular Therapy in the Dorsal Artery of the Pancreas in the United States
PHOENIX--(BUSINESS WIRE)--
Creative Medical Technology Holdings, Inc. ("Creative Medical Technology Holdings" or the "Company") (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that it has engaged Syneos Health (NASDAQ: SYNH) as the contract research organization (CRO) for its upcoming Phase 1/2 randomized, controlled clinical trial for the treatment of Type 1 Diabetes using the Company’s CELZ-201 cell therapy. The objective of the study, which is expected to commence during the first quarter of 2023, is to determine the safety and efficacy of CELZ-201 administration.
This engagement follows the Company’s recent announcements regarding the receipt of Institutional Review Board approval to proceed with this clinical trial (February 2023) and clearance by the U.S. Food and Drug Administration of its Investigational New Drug application for CELZ-201 to treat Type 1 Diabetes (November 2022).
The Company believes that CELZ-201 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, without immunosuppression and with large-scale clinical expansion.
“The commencement of this first-in-country clinical trial is a milestone event for Creative Medical Technology Holdings and a reflection of our commitment to developing novel therapies with the potential to address areas of high unmet medical need,” said Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc. “We are very pleased to have engaged Syneos Health, which brings a wealth of experience, insight, and know-how in the advancement of important therapies such as CELZ-201.”
Mr. Warbington concluded, “We remain supported in our efforts by a talented and dedicated team of employees and collaborators, and a strong financial position that provides us with the resources to drive our clinical development initiatives.”
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.
Special Note Regarding 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.
