ClearPoint Neuro Congratulates Partner PTC Therapeutics on Receiving Positive CHMP Opinion for Gene Therapy to Treat AADC Deficiency
The use of ClearPoint Neuros proprietary CE Marked SmartFlow Neuro Ventricular Cannula for minimally invasive infusion of the gene therapy is included in the submission for administration of Upstaza.
- The use of ClearPoint Neuros proprietary CE Marked SmartFlow Neuro Ventricular Cannula for minimally invasive infusion of the gene therapy is included in the submission for administration of Upstaza.
- This is a significant milestone for PTC Therapeutics, for ClearPoint and for biologics researchers everywhere as it marks the very first positive CHMP recommendation for direct injection to the brain of a gene therapy to treat a severe, highly morbid and fatal neurological disorder, commented Joe Burnett, President and CEO of ClearPoint Neuro.
- First, it provides a potential path for other therapies to follow and sets an important precedent for regulatory approval of direct administered gene therapies to the brain.
- And second, we see this as a validation of ClearPoints biologics partnership strategy and our rigorous bench, preclinical and clinical experience.