• 28 Feb 2024
• Admin
• News Article

Cynata Therapeutics Reported Positive Results from Phase I Trial

Cynata Therapeutics announces encouraging initial data from phase 1 trial of CYP-006TK to treat diabetic foot ulcer

Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, has completed initial analysis of wound surface area in the first 16 patients in its phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU), up to the 10-week follow-up time point.

Key Highlights: 

• The median percentage reduction in wound surface area in the active CYP-006TK group after 10 weeks was 87.6%, compared to 51.1% in the control group (n=8 per group); Recruitment in the trial is progressing well, with 25 out of a planned 30 participants now enrolled CYP-006TK is Cynata’s Cymerus iPSC1-derived MSC2 topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicon dressing.
• Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. 
• In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if treatment is unsuccessful, amputation may be necessary. 
• In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU. Enrolled participants 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.
• Follow-up visits in this trial continue until 24 weeks after the initiation of study treatment. At each follow-up visit, three-dimensional images of the study ulcer are taken using specialised camera equipment. 
• Images are then analysed by a technician who is independent of the clinical site and blind to treatment allocation. This facilitates calculation of the wound surface area, and consequently the change in the size of the wound over time.
• The analysis of the first 16 patients (n=8 per group) found that the median percentage reduction in wound surface area in the active CYP-006TK group after 10 weeks’ follow-up was 87.6%, compared to 51.1% in the control group.
• For clarity, a 100% reduction in wound surface area represents complete wound healing.
• These findings are consistent with the trend observed in the results from the first six patients enrolled in this trial (n=3 per group) up to Day 28, which were released in April 2023.

Future plans

In view of these very encouraging initial results, the company confirms that the trial will continue as planned, with the aim of enrolling a total of 30 participants. Recruitment has progressed well in recent months, with 25 participants now enrolled.

Word from Cynata

Dr Jolanta Airey MD, Cynata’s Chief Medical Officer, said: “These initial results are very promising, and consistent with the previous data readout. We look forward to completing enrolment in the near future, which will take us a step closer to our objective of demonstrating safety and efficacy of CYP-006TK in DFU.”

About Cynata Therapeutics

Cynata Therapeutics Limited 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.