Cynata’s (ASX:CYP) DFU clinical trial makes progress with addition of three new sites - Kalkine Media

March 16, 2023 03:22 PM AEDT | By Team Kalkine Media
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  • Cynata Therapeutics has added three new sites to the ongoing clinical trial of its cell therapy product CYP-006TK.
  • The study targets to enrol 30 patients affected by diabetic foot ulcers (DFU).
  • With this latest development, the company expects to release top-line data in the latter half of the current calendar year.

Clinical-stage biotechnology company Cynata Therapeutics Limited (ASX:CYP) has announced a new update highlighting progress of the ongoing clinical trial of CYP-006TK in patients with diabetic foot ulcers (DFU).

The trial has received a boost as the company has updated on the addition of three new clinical sites, located in Perth, Western Australia.

The three sites - Royal Perth Hospital, Fiona Stanley Hospital and Sir Charles Gairdner Hospital – will recruit patients in the ongoing trial, targeting the enrolment of a total of 30 patients with DFU.

Source: © 2023 Krish Capital Pty. Ltd.

DFU clinical trial data expected by end-2023 

Cynata expects speedy progress in relation to the patient enrolment in the trial, owing to the addition of new sites. The existing clinical sites will continue to enrol and treat patients without change.

Under the study, the patients will be randomised to receive either:

  • CYP-006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or
  • standard of care treatment throughout the study.

The company aims to wrap up the patient enrolment mid-way through 2023 and expects to release trial outcomes and top-line data by the end of the year.

CYP-006TK manufacturing for clinical sites

Cynata has also set up its unique CYP-006TK manufacturing process locally at The Ray and Bill Dobney Cell and Tissue Therapies WA (CTTWA) facility at Royal Perth Hospital. The facility will manufacture CYP-006TK for the new sites.

Meanwhile, the company will continue product manufacture at TekCyte for clinical sites in Adelaide.

Diabetic Foot Ulcers (DFU) – An unmet medical need


Source: © 2023 Krish Capital Pty. Ltd.

DFU are sores/wounds on the feet of patients with diabetes, which is one of the fastest growing chronic diseases globally. The company referring to independent market studies suggest that diabetes is forecast to affect 629 million adults by 2045, as compared to 425 million adults globally in 2017. Of the total diabetic population, 37% are at the risk of developing a foot ulcer.

CYP shares traded at AU$0.280 on 16 March 2023.



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