Plus Therapeutics, Inc. announced on June 25, 2025, that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for REYOBIQ™ (Rhenium Re186 Obisbemeda). This clearance is for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma.
The trial, referred to as ReSPECT-PBC, is funded by a $3.0 million research grant from the U.S. Department of Defense. This marks a significant expansion of REYOBIQ's clinical development into a new, highly underserved patient population.
The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose, safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years. This novel therapy has the potential to deliver higher doses of radiation directly into the tumor while limiting exposure to normal developing brain tissue.
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