Ann: Cynata Commences DFU Clinical Trial, page-5

Cynata Commences DFU Clinical Trial

Melbourne, Australia; 22 December 2021: Cynata Therapeutics Limited (ASX: “CYP” or “Cynata”), a clinicalstage biotechnology company specialising in cell therapeutics,

is pleased to announce its clinical trial of CYP-006TK in patients with diabetic foot ulcers (DFU) has commenced and is now open for patient enrolment.

The Phase I trial (protocol number CYP-DFU-P1-01) 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.

The trial will take place at Royal Adelaide Hospital and The Queen Elizabeth Hospital, Adelaide, under the leadership of Professor Robert Fitridge, who is Professor of Vascular Surgery at the University of Adelaide, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network.

Patients will receive study treatment for a period of 4 weeks, evaluation will continue for a total of 24 weeks. The primary outcome measure in the trial will be safety, while secondary outcome measures will include wound healing, pain and quality of life at 12 and 24 weeks after treatment initiation. Cynata currently expects to complete the trial during the 2022 calendar year.

Dr Kilian Kelly, Cynata’s Chief Operating Officer, said:

“Commencing the first human trial is a major milestone in the development of any new product, and we are pleased to have achieved this for our DFU program prior to the end of the year as projected. We look forward to evaluating the effects of this novel treatment on DFU, which are a debilitating and potentially limb or even life-threatening chronic complication of diabetes.”