In major news released today, Cynata Therapeutics announced that it had received favorable advice from the UK regulatory authority, a step forward in the development of its proprietary Cymerus™ therapeutic mesenchymal stem cell (MSC) technology. This input from the UK regulatory authority (MHRA) will allow Cynata to proceed with its plans to conduct a Phase 1 clinical trial in graft-versus-host disease in the UK. It also gives Cynata a clear path forward to commence the clinical development program of this valuable technology.
Formal meetings with other national regulatory bodies are scheduled within the coming weeks, the outcome of which will allow Cynata to consider further jurisdictions for the trial. The trial remains on track to commence during the second quarter of 2016. [Read more…]