Cynata Receives Ethics Approval to Commence Clinical Trial in COVID-19 and Clinical Development Update

8 May 2020

Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received ethics committee approval to commence a clinical trial to investigate early efficacy of Cynata’s proprietary CymerusTM mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19. In addition, the Company also provides updated guidance on its wider clinical development pipeline.

Key highlights

  • Ethics approval received for clinical trial in patients in intensive care with COVID-19 in Australia: the MEND (MEseNchymal coviD-19) Trial
  • Compromised lung function, which can ultimately progress to acute respiratory distress syndrome (ARDS), is a major complication in COVID-19 patients
  • This trial will build on Cynata’s strong pre-clinical study results in ARDS, sepsis and cytokine release syndrome, all of which are common hallmarks of severe COVID-19 cases
  • The MEND trial is an open-label, randomised controlled clinical trial to investigate early efficacy of Cymerus MSCs
  • Given restrictions in place for other clinical programs, Cynata is accelerating the COVID-19 / respiratory clinical development strategy

Dr. Ross Macdonald, Cynata’s CEO and MD, said:

“The ethics approval of this proposed clinical trial is a major milestone for Cynata and our proprietary Cymerus MSC technology. 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. 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.”

“This trial forms part of a broader clinical development strategy for our Cymerus MSC product to be trialled in COVID-19 patients in other countries. Our decision to focus on this new clinical development area is a logical and prudent step based on the current global environment and Cynata’s solid pre- clinical foundations in respiratory and related diseases.”


The MEND Trial is to be conducted at centres in New South Wales in collaboration with the Cerebral Palsy Alliance Research Institute and investigators from the COVID-19 Stem Cell Treatment (CSCT) Group. The study will be an open-label, randomised controlled clinical trial to investigate early efficacy of Cymerus MSCs in 24 adult patients admitted to intensive care with COVID-19 and respiratory distress.

Read the full ASX announcement.


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