OTLC - Oncotelic files with FDA to start trial of OT-101 for brain tumor in children
- Oncotelic Therapeutics ( OTCQB:OTLC ) said it submitted a clinical study protocol to the U.S. Food and Drug Administration (FDA) to start a phase 1 trial of OT-101 to treat pediatric patients with recurrent/relapsed Diffuse Midline Glioma (DMG).
- DMG is a type of brain tumor that comes from glial cells in the central nervous system.
- The phase 1 study, dubbed G101, will evaluate safety and tolerability of repeated cycles of OT-101, administered intraventricularly, in children with DMG.
- "This is the first of a series of planned clinical trials in pediatric patients with gliomas evaluating clinical benefit while also assessing predictive biomarkers," said Oncotelic Chairman and CEO Vuong Trieu.
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Oncotelic files with FDA to start trial of OT-101 for brain tumor in children