Oncotelic Therapeutics, Inc. announced that it has submitted a clinical study protocol to the US Food and Drug Administration (FDA) for the initiation of a Phase 1 Trial (designated "G101") for OT-101, the Company's transforming growth factor beta 2 (TGF-ß2) inhibitor, as a treatment for patients with recurrent/relapsed DMG. G101: An Open-label Dose Escalation Study to Evaluate the Safety and Tolerability of Repeated Cycles of OT-101 in Pediatric Diffuse Midline Glioma (DMG) Patients, Administered Intraventricularly. OT-101 is a first-in-class anti-TGF-ß2 ribonucleic acid ("RNA") therapeutic that has exhibited single agent activity in relapsed/refractory cancer patients in multiple clinical trials.
OT-101 has also demonstrated activity against the COVID-19 virus in Phase 2 clinical trial- C001.