4 January 2019 - FDA says proposed Phase 2 clinical trial may proceed.
OncoNano Medicine today announced that the U.S. FDA has accepted its investigational new drug application for ONM-100, an intravenously administered imaging agent to detect tumours and metastatic lymph nodes in solid cancers during surgery. In addition, OncoNano received fast track designation from the FDA for ONM-100.
ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumour and subsequently fluoresces in the acidic tumour microenvironment, which will allow surgeons to visualize the tumour during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.