Regeneus Ltd (ASX:RGS) has been granted a patent for the use of biomarkers to monitor disease progression in a patient having mesenchymal stem cell (MSC) therapy for inflammatory conditions.
The patent entitled “Biomarkers for cell therapy” will provide Regeneus with commercial rights in China until 2033.
Notably, the patent will provide protection for licensing the company’s Progenza allogeneic stem cell therapy platform in China.
Progenza is the company’s lead cell therapy technology being developed for the treatment of osteoarthritis and other musculoskeletal disorders.
READ: Regeneus close to finalising first clinical partnership for its lead cell therapy in Japan
There is increasing interest in China for in-licensing cell therapy technology platforms like Progenza.
In December 2017, the Chinese government announced new laws to accelerate the approval pathway for cell therapy products.
Two clinical phases in China
Under the new regime, cell therapy products will need to go through two clinical phases, (1) an early phase focused on safety; and (2) a confirmatory phase to demonstrate probable efficacy.
These new cell products will be available for government reimbursement.
Granted Chinese Patent Application No. 201480060270.X
The patent covers use of a broad range of MSC therapeutics for the treatment of inflammatory conditions in combination with the biomarkers.
The therapeutics include allogeneic and autologous cells where the MSCs can be sourced from any tissue type such as adipose, bone marrow or placental tissue and includes MSCs sourced from induced pluripotent stem cells and embryonic stem cells.
MSCs have well recognised anti-inflammatory effects and are used and being developed to treat a range of chronic inflammatory conditions including graft versus host disease, Crohn’s disease, cardiovascular disease and osteoarthritis.