Shares of Plus Therapeutics, Inc. (PSTV) were gaining around 120% in the pre-market activity on the Nadsaq after the company announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug or IND application for REYOBIQTM (Rhenium Re186 Obisbemeda) to treat pediatric brain cancers.
The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense.
The clinical-stage pharmaceutical company focused on central nervous system or CNS cancers noted that the approval was for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma or HGG and ependymoma.
Pediatric HGG including ependymoma are rare but aggressive brain tumors with limited treatment options and poor prognosis, mainly in recurrent settings.
Plus Therapeutics' REYOBIQ is a novel radiotherapeutic designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue.
The company noted that REYOBIQ's targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients.
The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose or MTD, safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years, and with consideration for patients up to 25 years on a case-by-case basis.
Ashley Plant, Principal Investigator for the trial, said, "We are very excited for the opportunity to study the novel radiotherapeutic, REYOBIQ, in difficult-to-treat pediatric brain tumors. Surgery and external beam radiation have been the mainstays of treatment for pediatric high-grade glioma and, sadly, outcomes have not improved for many decades. We believe this novel therapy that may allow higher doses of radiation while limiting the exposure to normal developing brain and delivering this agent via convection enhanced delivery (CED) directly into the tumor has the potential to make a big difference in our patients' lives and improve outcomes."
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