( MENAFN - GlobeNewsWire - Nasdaq) .Regenerative medicine Advanced Therapy (RMAT) designation follows phase I clinical trial results demonstrating that bemdaneprocel is well tolerated with no major safety issues through 18 months .Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.
S. for treating patients living with Parkinson's disease Berlin, Germany and Cambridge, MA, USA, May 30, 2024 (GLOBE NEWSWIRE) -- Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced today that BlueRock's investigational cell therapy bemdaneprocel for the treatment of Parkinson's disease has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S.
Food and Drug Administration (FDA). “We are excited about the positive data from the bemdaneprocel phase I clinical trial and believe it has great potential to help patients living with Parkinson's disease regain functions they have lost to the disease,” said Seth Ettenberg, President and CEO of BlueRock Therapeutics.“Now with this RMAT designation in hand, we look forward to closely collaborating with the FDA to ready this program for phase II clinical studies.
” Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating Parkinson's disease.
Phase I clinical trial data announced in March demonstrated that at 18 months it was well tolerated with no majo.
