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Cynata Therapeutics (ASX:CYP) - Managing Director & CEO, Dr Ross Macdonald
Managing Director & CEO, Dr Ross Macdonald
Source: Cynata Therapeutics
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  • Cynata Therapeutics (CYP) appoints clinical research organisation Datapharm Australia to assist with its clinical trials in diabetic foot ulcers
  • Datapharm will assist in the conduct and management of the proposed clinical trial of Cynata’s Cymerus mesenchymal stem cell (MSC) product
  • The deal marks a step closer to commencing the trial, since CYP partnered with TekCyte earlier this month to develop an “active dressing”
  • However, regulatory and ethics clearance and completion of trial start up activities are required before the trial can begin
  • Shares have dropped 2.9 per cent to trade at 50.5 cents at 3:12pm AEST

Cynata Therapeutics (CYP) has appointed clinical research organisation (CRO) Datapharm Australia to assist with its clinical trials in diabetic foot ulcers.

Datapharm is considered a leading CRO that provides a range of services for clinical trials.

Through the deal, the CRO will specifically assist in the conduct and management of the proposed clinical trial of Cynata’s Cymerus mesenchymal stem cell (MSC) product in diabetic foot ulcers.

CYP maintains that diabetic foot ulcers represent a significant unmet medical need, with an estimated market value approaching US$10b1 (A$12.9 billion).

Earlier this month, the company announced a partnership with Adelaide-based biotechnology company, TekCyte, to utilise its surface modification technologies, that produce polymer-coated dressings to deliver MSCs to wounds.

Following encouraging results from studies of TekCyte’s dressing seeded with MSCs or similar cells, the companies are now working together to manufacture and supply the active dressing for the planned clinical trial in diabetic foot ulcers.

CYP said substantial progress has been made on the clinical trial design and endpoint selection, and the deal with Datapharm represents an important milestone towards commencing the trial.

However, commencement of the trial is subject to regulatory and ethics clearance and completion of trial start up activities, all of which the company said are presently underway.

Further, CYP expects patient enrolment for the trial will be initiated in the second half of this year.

While no information regarding costs has been shared, the company said the value of the contract with Datapharm is not considered material from a quantitative perspective.

Shares dropped 2.9 per cent to trade at 50.5 cents at 3:12pm AEST.

CYP by the numbers
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