- Cynata Therapeutics (CYP) reveals an independent data safety monitoring board (DSMB) completes its review of the company’s diabetic foot ulcer (DFU) trial
- Following the review, the DSMB recommended that the clinical trial continue as planned
- Chief Medical Officer Dr Jolanta Airey said the positive recommendation is a key milestone which enables the company to continue patient enrolment as planned and complete the trial as soon as possible
- Shares in Cynata are up 5.88 per cent to close at 36 cents
Cynata Therapeutics (CYP) has revealed an independent data safety monitoring board (DSMB) has completed its review of the company’s diabetic foot ulcer (DFU) trial.
DFUs are chronic wounds on the feet of patients with diabetes which could potentially lead to serious infection and amputation, and represents a very significant unmet need affecting up to 34 per cent of diabetes patients.
Following the review, the DSMB has recommended that the clinical trial continue as planned.
According to the company, undertaking a review by an independent DSMB is consistent with good clinical practice.
Chief Medical Officer Dr Jolanta Airey said the positive recommendation is a key milestone which enables the company to continue patient enrolment as planned and complete the trial as soon as possible.
The trial is investigating the safety and early efficacy of the company’s unique topical Cymerus mesenchymal stem cell (MSC) product, CYP-006TK, in patients with DFUs.
The primary responsibilities of the DSMB are to review and evaluate the available study data for participant safety, study conduct and progress.
Also, the DSMB can make recommendations concerning the continuation, modification or termination of the trial.
The study protocol includes oversight by a DSMB and provision for an interim review which has now been successfully completed.
Shares in Cynata were up 5.88 per cent to close at 36 cents.