- Cynata Therapeutics (CYP) has received approval from the U.K. Medicines and Healthcare products Regulatory Agency to begin the phase 2 trial of CYP-002
- This product will be used in patients with reduced blood flow in their limbs
- The company anticipates conducting the clinical trial at multiple centres in the U.K. and Australia
- Cynata’s share price is up a slight 0.83 per cent with shares currently trading for $1.21 apiece
Cynata Therapeutics (CYP) has received approval from the U.K. Medicines and Healthcare products Regulatory Agency to begin the phase 2 trial of CYP-002.
This trial will see Cynata’s Cymerus mesenchymal stem cell (MSC) product, CYP-002, be used in patients with critical Limb Ischaemia (CLI).
CLI is an advanced stage of peripheral artery disease (PAD) which is a narrowing of arteries in the limbs, particularly the legs.
The risk of PAD is increased in patients with diabetes, high blood pressure, obesity, and people who smoke.
CLI often results in the amputation of the affected limb and is a major risk factor for cardiovascular events such as a heart attack.
The value of the global CLI treatment market has been forecasted to reach US$4.5 billion (AUD$6.5 billion) by 2025.
MSCs are adult stem cells found in a wide range of human tissues including bone marrow, placenta and fat tissue.
They are multi-potent which means they can produce more than one type of cell. For example, they can differentiate into cartilage cells, fat cells and bone cells.
They have been shown to ease regeneration and effects on the immune system without relying on engraftment (when transplanted cells start to grow and make healthy cells).
Cynata’s MSCs have been successfully treated in a mouse model of CLI.
Muscles on the ischaemic leg were either injected with MSCs or a control.
Over a four-week follow-up period, the return of blood flow was measured and in animals treated with MSCs, blood flow in the injured limb was higher at every point compared to the control.
“The approval of this phase 2 clinical trial by the MHRA is a major advancement for the development of Cymerus MSCs,” Chief Operating Officer Dr Kilian Kelly commented.
“The approval also confirms the successful implementation of the company’s strategy to use the positive phase 1 trial of Cymerus MSCs in graft versus host disease to support direct progression from preclinical to phase 2 clinical studies for CLI snf multiple other indications,” he added.
Cynata anticipates conducting the clinical trial at multiple centre in the U.K. and Australia.
Cynata’s share price is up a slight 0.83 per cent with shares trading for $1.21 apiece at 1:24 pm AEDT.