- Cynata Therapeutics is working towards Phase 2 clinical trial activities to evaluate its Cymerus mesenchymal stem cells in osteoarthritis
- Osteoarthritis affects two million Australians and 30 million people in the USA
- A Research Support Agreement has been signed to accelerate trial planning and start-up activities
Cynata Therapeutics is gearing towards Phase 2 clinical trial activities to evaluate Cynata’s Cymerus mesenchymal stem cells (MSCs) as treatment for osteoarthritis.
Osteoarthritis is a chronic joint disease that causes pain and disability and affects around two million Australians and 30 million people in the U.S.A.
It’s described as a condition that effects the whole joint including bone, ligaments, muscles and cartilage, caused by the wear and tear of joints working extra hard.
Market research estimates that the resulting global osteoarthritis market is expected to grow from US$8 billion in 2018 to US$11.6 billion by 2025.
“We are very pleased that we are now able to explore the potential role of our Cymerus MSCs in improving the quality of life for patients living with the huge disease burden caused by osteoarthritis,” Cynata Vice President Dr Kilian Kelly said.
Significant progress has been made with the University of Sydney for the Phase 2 study to be undertaken using Cynata’s Cymerus MSCs.
Cymerus is the process of generating cell-based products from intermediate cells which are derived from induced pluripotent stem cells. These stem cells can also multiply indefinitely.
Cynata is currently focused on the production of mesenchymal stem cells (cells that can differentiate into a variety of cell types).
Through a Research Support Agreement Cynata’s commercial rights has been confirmed and planning and start-up activities are now advancing rapidly.
“Signing this Research Support Agreement with the University of Sydney confirms Cynata’s rights to make this treatment commercially available, if successful, and enables us to finalise the trial design,” Kilian said.
The aim of the Phase 2 clinical trial is to assess the effect of Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two year period.
The trial will be led by Professor David Hunter who has been a chief investigator of numerous clinical trials in osteoarthritis.
The conduct of the trial will be led by the University of Sydney and funded by an Australian National Health and Medical Research Council.
Subject to obtaining relevant ethics and regulatory approvals, Cynata will manufacture and supply Cymerus MSCs for use in the trial.
Under the agreement, full commercial rights to use Cymerus MSCs in osteoarthritis are retained by Cynata.
This trial marks one of the largest MSC trials to ever be conducted that will showcase Cynata’s MSC manufacturing capability.