Cynata Adds New Sites for DFU Clinical Trial

Posted: 17 March 2023

Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, has announced that three additional clinical sites have opened for recruitment in the ongoing clinical trial of CYP-006TK in patients with diabetic foot ulcers (DFU). This trial aims to enrol a total of 30 patients with DFU, who are randomised to receive either: (i) CYP-006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study.

The additional clinical sites are all based in Perth, Western Australia, namely the Royal Perth Hospital, Fiona Stanley Hospital and Sir Charles Gairdner Hospital. The Company has also established its unique CYP-006TK manufacturing process locally at The Ray and Bill Dobney Cell and Tissue Therapies WA (CTTWA) facility at Royal Perth Hospital (RPH), to manufacture CYP-006TK for the new sites. It is expected that the inclusion of these additional hospitals will accelerate enrolment in the trial. The Company aims to complete recruitment mid-way through 2023 with trial results and top-line data to be released by the end of the year.

Cynata’s current clinical sites will continue to enrol and treat patients without change, and the Company looks forward to continuing its relationships with these prestigious hospitals. Similarly, product manufacture at TekCyte for clinical sites in Adelaide will also continue without change.

Dr Ross Macdonald, Cynata’s Chief Executive Officer, said:

“We are excited with the addition of three new clinical sites to our ongoing DFU trial. Increasing the number of sites will help us drive recruitment activity and achieve our goal of releasing top-line data by the end of 2023. We remain confident that our cell therapy products offer a unique solution to those affected by DFUs, which is a large portion of the 400 million diabetics globally, and look forward to updating the market with trial progress.”

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

“We are very pleased with this important progress towards increasing patient numbers for our ongoing DFU clinical trial and to ensuring we are on track to complete the trial on schedule. Notably, Perth has a rich history of innovation and successful clinical translation in regenerative medicine technologies, with the ground-breaking research on “spray on skin” having been conducted in Perth. We look forward to working with CTTWA and the new clinical sites in this important and challenging target.”

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