Biotechnology company TME Pharma N.V. (Euronext Growth Paris:ALTME) announced on Friday final median overall survival (mOS) data for the NOX-A12 combination regimen in the GLORIA expansion arm.
Among newly diagnosed patients with glioblastoma receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy, mOS has reached 19.9 months.
Glioblastoma is an aggressive type of brain cancer.
The survival rate in this cohort at 21 months is 10-fold greater than a reference cohort of matched patients receiving standard of care (50% vs. 5%).
Based on the data, TME Pharma has submitted an Investigational New Drug (IND) application and a Fast-Track Designation request to the US Food and Drug Administration (FDA) for the use of NOX-A12 in the treatment of glioblastoma.
The company is targeting approval of the IND and a decision on the Fast-Track Designation before the end of March 2024.
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