Cynata retains all the commercial rights to use the Cymerus MSCs in osteoarthritis and would pay up to A$2.1m ($1.42m) as fees to the University of Sydney for the Phase II trial
Image: The Phase II clinical trial is aimed at evaluating the Cymerus MSCs. Photo: Courtesy of Dr. Manuel González Reyes from Pixabay.
Australia-based clinical-stage biotechnology company Cynata Therapeutics has signed an agreement with the University of Sydney as part of the Phase II clinical trial to evaluate its Cymerus mesenchymal stem cells (MSCs) in treating osteoarthritis.
Cynata said that it has collaborated with the University of Sydney for the Phase II study of Cymerus MSCs and has signed a Research Support Agreement.
Cynata product development vice-president Kilian Kelly said: “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.
“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 finalize the trial design and move more quickly through the planning and start-up phase.”
Cynata will pay $1.42m fees to the University of Sydney
Osteoarthritis is a chronic form of arthritis characterised by pain and disability and occurs when the protective cartilage that pads the ends of bones wears down over time. The disease can damage any joint and is commonly observed affecting joints of hands, knees, hips and spine.
Cynata said that it is a stem cell and regenerative medicine company that develops therapies based on Cymerus, a proprietary therapeutic stem cell platform technology, using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA).
Cymerus is capable of overcoming challenges faced by other production methods, including economic production cell therapy products such as MSCs in commercial scale and shortage of multiple donors.
Under the terms of the agreement, Cynata retains all the commercial rights to use the Cymerus MSCs in osteoarthritis, and would pay up to A$2.1m ($1.42m) as fees to the University of Sydney if the results of Phase II trial are used for regulatory marketing approval of Cymerus MSCs for the treatment of osteoarthritis.
The Phase II clinical trial is aimed at evaluating the Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two-year period in 448 patients with osteoarthritis of the knee.