TME Pharma has announced a successful pre-Investigational New Drug (IND) meeting with the FDA, paving the way for olaptesed pegol (NOX-A12) for the treatment of glioblastoma (GBM), a deadly brain cancer.
The highly anticipated GLORIA, a Phase 1/2 trial, has yielded encouraging data, and the FDA discussions solidified TME Pharma’s belief in NOX-A12’s potential to revolutionize GBM treatment by exploring new paths in this aggressive cancer fight. The final trial design, incorporating valuable FDA feedback, will be unveiled once finalized.
Aram Mangasarian, CEO of TME Pharma, emphasized the FDA’s constructive feedback as invaluable. With a clear regulatory path and the encouraging data from our GLORIA trial, TME Pharma is confident in securing funding through partnerships or investments by Q1, bringing them closer to realizing the potential of NOX-A12 for GBM patients.
This opens the door for an IND filing and potential access to an expedited regulatory pathway by the end of Q1 2024.
Source: TME Pharma Announces Successful Advice Meeting With US Food and Drug Administration on NOX-A12 Development in Brain Cancer
https://www.businesswire.com/news/home/20240109528639/en/TME-Pharma-Announces-Successful-Advice-Meeting-With-US-Food-and-Drug-Administration-on-NOX-A12-Development-in-Brain-Cancer
