BlueRock Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase I study.
“Receiving Fast Track Designation from the FDA is an important step, which will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson’s disease,” said Joachim Fruebis, BlueRock’s Chief Development Officer. “This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition.”
The trial will enrol ten patients in the US and Canada. The primary objective of the Phase I study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.