Creative Medical Technology has hired Syneos Health to trial its candidate type I diabetes cell therapy, CELZ-201.
The Phase I/II study – which is expected to start this quarter – will take place at the University of Miami in Florida according to a post of ClinicalTrials.gov. It was given the green light by the US Food and Drug Administration (FDA) in November.
Creative Medical Technology’s CEO Timothy Warbington cited Syneos’ experience trialing advanced therapies as key to winning the clinical research organization (CRO) the contract.
“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.
“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” Warbington said.
CELZ-201 is made from perinatal Tissue Derived Cells (PRDC) which – Creative Medical Technology says – means it has several advantages, including self-renewal ability, low antigenicity, reduced toxicity, without immunosuppression and the potential for large-scale clinical expansion.
The potential market for the product is significant. According to Creative Medical Technology, as of 2019, there were 1.6 million adults aged 20 years or older diagnosed with Type 1 Diabetes (T1D) in the US.
In addition, the firm says that 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.
Syneos and cell therapy
The contract is the latest indication Syneos sees the cell and gene therapy sector as a growth market. In January the CRO partnered with temperature-controlled supply chain solutions provider Cryport in a deal designed to designed to boost both firms’ standing in the sector.
More recently – at the Phacilitate conference – Syneos spoke about the role CROs can play in advancing the development of cell therapies. According to the firm simplifying the supply chains involved in cell therapy trials should be a focus for industry.
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