Posted by Michael Wonder on 05 Jan 2023
OncoNano Medicine’s pegsitacianine granted breakthrough therapy designation for real-time surgical imaging by the FDA
4 January 2023 - OncoNano Medicine today announced that its lead clinical development candidate, pegsitacianine, a pH sensitive fluorescent nanoprobe for image-guided cancer surgery, has received breakthrough therapy designation by the US FDA as an adjunct for the visualisation of metastatic disease in the peritoneal cavity in patients undergoing cytoreductive surgery.
Based on the results of an on-going Phase 2 clinical trial evaluating the safety and efficacy of pegsitacianine following standard of care cytoreductive surgery, pegsitacianine enabled surgeons to detect additional cancerous tissue at a clinically significant rate of >50%.
