NeOnc Technologies Secures UAE IND Clearance for NEO212, Sets 610mg Phase 2 Dose
NTHI•NeOnc Technologies secured Abu Dhabi IND approval to move NEO212 into Phase 2 after Phase 1 dose-escalation set 610 mg as the recommended dose. This first international regulatory clearance for NEO212 underpins global Phase 2 planning and ongoing U.S. FDA registrational pathway discussions.
1. IND Approval Enables Phase 2 Launch
NeOnc Technologies received Investigational New Drug clearance from the Department of Health – Abu Dhabi, authorizing the company to initiate Phase 2 evaluation of NEO212 in aggressive brain tumor patients. This clearance represents the first international regulatory nod for NEO212, expanding its clinical footprint beyond U.S. discussions.
2. Phase 1 Dose-Escalation Established 610 mg
The completed Phase 1 trial identified 610 mg as the recommended Phase 2 dose based on dose-escalation data showing potential durable disease stabilization in recurrent glioblastoma and brain metastases. Safety and tolerability profiles supported advancement without new adverse signals.
3. Parallel U.S. FDA and UAE Strategy
NeOnc will satisfy DOH conditions, including IRB approval and protocol amendments, before enrolling UAE patients. Concurrently, the company is engaged in U.S. FDA discussions to define a registrational pathway, aiming to synchronize global development and accelerate potential approval.
