The U.S. Food and Drug Administration has cleared Plus Therapeutics’ (NASDAQ:PSTV) Investigational New Drug application for REYOBIQ to treat pediatric patients with high-grade glioma and ependymoma, the company announced Wednesday.
The Phase 1/2a clinical trial, named ReSPECT-PBC, will be funded by a $3.0 million grant from the U.S. Department of Defense. The study will enroll children aged 6 to 21 years, with consideration for patients up to 25 years on a case-by-case basis.
The trial will follow a two-part design. Phase 1a/b will enroll approximately 24 patients to establish the maximum tolerated dose, while Phase 2a will include about 32 patients to assess efficacy.
REYOBIQ (Rhenium Re186 Obisbemeda) is designed to deliver beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue. The treatment uses convection enhanced delivery to bypass the blood-brain barrier.
"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," said Dr. Ashley S. Plant, Principal Investigator for the trial and attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago.
Pediatric high-grade gliomas, including ependymoma, are rare but aggressive brain tumors with limited treatment options. Standard treatments often fail to prevent recurrence, with five-year survival rates as low as 22% for high-grade glioma.
The pediatric trial builds on Plus Therapeutics’ adult recurrent glioblastoma trial (ReSPECT-GBM), which according to a press release statement showed favorable safety and clinical response.
https://www.investing.com/news/company-news/fda-clears-plus-therapeutics-pediatric-brain-cancer-treatment-trial-93CH-4110233
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