NeOnc receives FDA authorization to proceed with Phase II clinical trial of NEO212 for brain cancer

NEONC TECHNOLOGIES HOLDINGS, INC.

FDA cleared NEO212-01 Phase IIa/IIb after Phase I showed safe dosing up to 810 mg daily days 1–5 of 28-day cycle.
Patient enrollment expected to begin before end of 2025 at up to 16 U.S. cancer centers including Cleveland Clinic, Duke, and USC.
NEO212 is an oral chemical conjugate of TMZ (Temodar) and NEO100 (perillyl alcohol), designed to enhance blood-brain barrier penetration.
Company believes NEO212 could replace TMZ as standard of care for glioblastoma, astrocytoma, and other CNS cancers.
CEO Dr. Thomas Chen and Executive Chairman Amir Heshmatpour highlighted milestone as transformative for brain cancer treatment.

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