Clinical-stage biotechnology company specialising in cell therapeutics Cynata Therapeutics (ASX:CYP) has provided an update on the planned clinical trials of its Cymerus mesenchymal stem cell (MSC) products for osteoarthritis and critical limb ischemia (CLI).
The company said it continues to liaise closely with partners, regulatory authorities and relevant collaborators to track the impact of the current COVID-19 pandemic on upcoming and ongoing studies.
In relation to the phase 2 osteoarthritis trial, it said "good progress continues to be made toward obtaining approval by the University of Sydney Human Research Ethics Committee (HREC)."
"This is a key milestone in the procedural aspects toward commencing the trial," said the company, adding it is working with trial co-ordinators to ascertain the impact of COVID-19 on the possible schedule for trial commencement.
"The Clinical Trial Support Office of the University of Sydney has advised that newly approved trials should not commence trial participant involvement (first visits) until further notice. This advice is expected to remain in place until the COVID-19 situation resolves," said the company in a statement.
It added, "In the meantime, Cynata will continue to work with the trial Chief Investigator, Professor David Hunter, to continue to prepare for the trial to be ready for enrolment when the current restrictions are removed."
The company said patient recruitment in the phase 2 CLI trial "will also face timing uncertainty until the current COVID-19 situation resolves."
Cynata said its ongoing preclinical program is progressing on schedule. The key active pre-clinical study is in Acute Respiratory Distress Syndrome (ARDS) with initial results expected by mid-2020.
Dr Ross Macdonald, Cynata managing director and CEO, said, “Despite the dynamic and unprecedented environment we now face during the coronavirus pandemic we continue to make good progress toward completing start-up activities for the planned Phase 2 trials in osteoarthritis and CLI.
"We expect to be in a good position to commence recruitment once current measures are relaxed, but prudence dictates that we accommodate these uncertainties into our scheduling. We will continue to progress activities towards the final stage before clinical trial commencement and will actively monitor the evolving developments, providing further guidance as the situation progresses.”