LL schreef op 30 mei 2024 13:28:
Bayer: 'RMAT' designation obtained in US for Parkinson's(CercleFinance.com) - Bayer announced on Thursday that the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the experimental Parkinson's disease treatment currently being developed by its subsidiary BlueRock Therapeutics.
Like fast track and breakthrough designations, RMAT status was created by the FDA to accelerate the approval of promising regenerative medicines with the potential to treat serious diseases.
This announcement comes as BlueRock's cell therapy, bemdanéprocel, was well tolerated without major safety issues in an 18-month Phase 1 study.
With a Phase II study currently in preparation, Bayer considers bemdanéprocel to be the most advanced investigational cell therapy in the US for the treatment of Parkinson's disease.
Bemdanéprocel aims to replace the dopamine-producing neurons destroyed in Parkinson's disease with cells derived from human embryonic stem cells.