Cynata Advances Clinical Trial in Diabetic Foot Ulcers

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Melbourne, Australia; 21 April 2022: Cynata Therapeutics Limited (ASX: “CYP” or “Cynata”), a clinicalstage biotechnology company specialising in cell therapeutics, is pleased to announce enrolment of initial patients in a clinical trial of CYP-006TK as a potential treatment for diabetic foot ulcers (DFU). Subjects are now being followed as planned for the 4-week treatment period out to the conclusion of the study at 24 weeks. As advised in an announcement dated 22 December 2021, the Phase I trial (protocol number CYP-DFUP1-01) aims to recruit 30 adult patients with DFU who will be randomly assigned to receive CYP-006TK or standard care of treatment. CYP-006TK is a novel polymer-coated silicon wound dressing seeded with Cymerus™ mesenchymal stem cells (MSCs) to facilitate topical application to the wound. Cynata has exclusively licensed the dressing technology from leading manufacturer of innovative biomedical coatings, TekCyte Limited. Dr Jolanta Airey, Cynata’s Chief Medical Officer, said: “We are pleased with enrolment of subjects following the commencement of the trial in late December. COVID-19-related changes to patient management at the study sites, initiated shortly after the trial opened, posed a significant number of unforeseen challenges which had a serious impact on enrolment rates. Fortunately, these challenges have now been addressed. Additionally, we have implemented a number of strategies, such as widening recruitment criteria, intended to accelerate recruitment of subjects. We continue to work closely with Professor Fitridge and his team at the Central Adelaide Local Health Network to ensure we meet current expectations to complete the trial later this year.”