Ethics Approval for Cynata’s Clinical Trial in Diabetic Foot Ulcers

Key highlights

• Ethics approval received for clinical trial in patients with diabetic foot ulcers
• First clinical trial to utilise the wound dressing technology recently licensed from TekCyte
• Patient recruitment expected to commence in 2H CY21

MELBOURNE, Australia, June 30, 2021 (GLOBE NEWSWIRE) — Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received approval by the Central Adelaide Local Health Network Human Research Ethics Committee to commence a clinical trial of Cynata’s Cymerus™ mesenchymal stem cell (MSC) product in patients with diabetic foot ulcers.

The trial, entitled “A Randomised, Controlled, Phase 1 Study to Investigate Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers”, aims to recruit 30 participants, who will be randomly assigned to receive either CYP-006TK or standard care treatment. This will be the first clinical trial to utilise CYP-006TK, a polymer-coated silicon dressing (seeded with Cymerus MSCs) that Cynata has licensed from TekCyte Pty Ltd (TekCyte). As announced on 28 June 2021, Cynata has engaged leading clinical research organisation, Datapharm Australia, to assist in the conduct and management of the trial.

The investigational treatment period is 4 weeks, and each patient will be evaluated for a total of 24 weeks. The primary endpoint of the trial is safety, while secondary efficacy endpoints include the following outcome measures after 12 and 24 weeks:

• Percentage ulcer area change
• Days to complete ulcer healing
• Days to 50% ulcer healing
• Percentage change in ulcer volume
• Ulcer pain

The trial will take place at Royal Adelaide Hospital and The Queen Elizabeth Hospital in Adelaide, under the leadership of Professor Robert Fitridge, who is Professor of Vascular Surgery at the University of Adelaide, Head of Vascular Surgery at The Queen Elizabeth Hospital, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network. Patient recruitment is expected to commence in the second half of this year, subject to the completion of customary regulatory and administrative approvals, as well as other trial start up activities, which are currently underway.

A corporate presentation on the DFU clinical trial is attached to this announcement.

Dr Kilian Kelly, Cynata’s Chief Operating Officer, said:
“Diabetic foot ulcers can severely impact quality of life, and often result in hospitalisation, amputation and even death. Existing treatment options often fail to heal diabetic ulcers in a timely manner, if at all, so new and more effective treatments are urgently needed. The estimated market value for diabetic foot ulcer treatments is already approaching US$10b,¹ and that figure is likely to grow significantly in the future, in tandem with the growth in the incidence of diabetes worldwide. We are on target to commence the trial this year and look forward to working with Professor Fitridge and his team on this important study.”

Authorised for release by Dr Ross Macdonald, Managing Director & CEO

About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Clinical trials of Cymerus MSC products in osteoarthritis (Phase 3) and in patients with respiratory failure are currently ongoing. Planning is also underway for further clinical trials of Cymerus MSC products in GvHD (through licensee Fujifilm), diabetic foot ulcers, critical limb ischemia, idiopathic pulmonary fibrosis, and renal transplantation. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of numerous diseases, including the clinical targets mentioned above, as well as asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.

¹ Transparency Market Research, 2020 (Reflects global DFU treatment market by 2027).