- Cynata Therapeutics (CYP) is making progress towards a phase three clinical trial of its Cymerus stem cell treatment for osteoarthritis
- The Therapeutic Goods Administration has advised the trial can be
conducted through an expedited approval process
- Once the necessary documentation has been provided, the Sydney University research team conducting the trial can proceed with patient enrolment if COVID-19 protocols allow for it
- While there’s still a long road ahead, Cynata has taken an important step in getting its novel stem cell treatment to market
- Cynata Therapeutics is trading 11.5 per cent higher today at 68 cents per share
Cynata Therapeutics (CYP) is making progress towards a phase three clinical trial of its Cymerus mesenchymal stem cell (MSC) treatment for osteoarthritis.
The Therapeutic Goods Administration (TGA) has advised that the trial can be
conducted under the Clinical Trial Notification (CTN) scheme, which will expedite the approval process for the trial.
The Cymerus trial has been formally approved by the University of Sydney Human Research Ethics Committee (HREC).
The university is sponsoring the trial, which will be funded by an Australian Government National Health and Medical Research Council (NHMRC) competitive project grant.
Cynata will supply Cymerus MSCs for use in the trial, but won’t be required to contribute funds.
The University of Sydney originally intended to use the Clinical Trial Exemption (CTX) approval route for the trial, but the TGA has advised the trial can instead be conducted under the expedited CTN scheme.
Under the terms of the CTN scheme, Cynata must supply Good Manufacturing Compliance documentation and notification of the trial to the TGA, which circumvents the formal review and approval process required under the CTX scheme.
Cynata Chief Operating Officer, Dr Kilian Kelly, says the company has achieved an important milestone.
“We are delighted to gain ethics approval for this important phase three clinical trial in osteoarthritis patients,” Kilian said.
“We look forward to providing further information around the timing of commencement of patient recruitment once more clarity is available regarding the lifting of COVID-19-related restrictions.”
Once the necessary documentation has been provided, the Sydney University team can proceed with patient enrolment — if COVID-19 protocols allow for it.
Once it gets the go-ahead, the trial aims to recruit 440 patients at study centres in Sydney and Tasmania.
The trial will test patient response for osteoarthritis of the knee. Patients will be treated over the course of 12 months with either Cymerus MSCs or a placebo and then monitored for a further two years.
While there’s still a long road ahead, Cynata has taken an important step in getting its novel stem cell treatment to market.
Cynata Therapeutics is trading 11.5 per cent higher today at 68 cents per share as at 11:10 am AEST.