- Biotech Cynata Therapeutics (CYP) has received ethics committee approval to start a clinical trial on intensive care patients with COVID-19
- The trial will use Cynata’s Cymerus mesenchymal stem cells (MSC) technology
- Cymerus has previously shown promising clinical trial results in several conditions that can arise from severe COVID-19 infections, such as ARDS, sepsis and cytokine release syndrome
- CEO Ross Macdonald says this ethics approval is a major milestone for Cynata
- Cynata is also looking to expand this COVID-19 trial to other jurisdictions
- Cynata is up 16 per cent on the market this morning, selling shares for 76 cents each
Biotech Cynata Therapeutics (CYP) has received ethics committee approval to start a clinical trial on intensive care patients with COVID-19 using its Cymerus mesenchymal stem cells (MSC) technology.
The MEND (MEseNchymal CoviD-19) trial will be conducted across centres in New South Wales. The company will work with the Cerebral Palsy Alliance Research Institute and investigators from the COVID-19 Stem Cell Treatment (CSCT) Group.
The study will be a randomised controlled clinical trial to investigate the early efficacy of Cymerus MSCs in 24 adults who are in intensive care with COVID-19 and respiratory distress.
Twelve patients will be tested using Cymerus and the standard of care, while the other twelve will just receive the standard of care.
Cynata is also looking to expand this COVID-19 trial to other jurisdictions.
Cymerus has previously shown promising clinical trial results in several conditions which can arise from a severe COVID-19 infection such as ARDS, sepsis and cytokine release syndrome.
ARDS is an inflammatory process which builds-up fluid in the lungs and respiratory failure. It can occur due to infections, trauma and inhalation of noxious substances and is one of the most common life-threatening complications of COVID-19.
CEO Ross Macdonald says this ethics approval is a major milestone for Cynata.
“Our substantial pre-clinical database in relevant disease models, together with the urgent need for more effective treatments for critically ill patients with COVID-19, allowed us to accelerate planning and rapidly achieve ethics committee approval,” he said.
“We are pleased to be able to move so quickly to further investigate the potential benefits our MSCs could have to treat patients in dire need during this global pandemic,” Ross added.
Clinical development pipeline
Cynata’s licence partner, FUJIFILM, continues to progress further development of CYP-001, which is a Cymerus product for the treatment of graft-versus-host disease (GvHD).
While the clinical trial recruitment is under restrictions due to the pandemic, the study start-up activities for the osteoarthritis (OA) and critical limb ischaemia (CLI) phase two trials are continuing.
The phase two OA trial has been reviewed by the University of Sydney Human Research Ethics Committee. Final approval for the trial is expected in the near future.
The phase two CLI trial has now been approved in Australia from the Melbourne Health MHRA.
This follows approval from earlier this year by the U.K. Medicines and Healthcare Products Regulatory Agency.
However, COVID-19 restrictions will have an impact on potential recruitment, because CLI patients are at a higher risk of developing serious implications with COVID-19.
So, due to this, the company has decided to pause recruitment until general restrictions are more relaxed.
Cynata is up 16 per cent on the market this morning, selling shares for 76 cents each at 10:51 am AEST.