Business

Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer

Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll children with high grade glioma and ependymoma HOUSTON, June 25, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has clear

articlePlus Therapeutics, Inc.June 25, 20257/company/plus-therapeutics-inc/news/plus-therapeutics-announces-fda-clearance-113000350
Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer

About this update from Plus Therapeutics, Inc.

[{"type":"image","alt":"Plus Therapeutics Inc.","displaySize":"","headline":null,"caption":"Plus Therapeutics Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":172,"url":"https://media.zenfs.com/en/globenewswire.com/1d6738db871d52da7de4b5de8e51921c"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/iUBJ3sPkI4ud4lMmyJb.Bg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTI0MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/1d6738db871d52da7de4b5de8e51921c","width":300,"height":172}},"lazy":false},{"type":"text","content":"Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense","length":105,"tagName":"p"},{"type":"text","content":"Trial will enroll children with high grade glioma and ependymoma","length":64,"tagName":"p"},{"type":"text","content":"HOUSTON, June 25, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. 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.","length":702,"tagName":"p"},{"type":"text","content":""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,” said Dr. Ashley S. Plant, M.D., Principal Investigator for the trial, attending physician in Hematology, Oncology, Neuro-oncology, and Stem Cell Transplantation at Ann & Robert H. Luri...

More updates from Plus Therapeutics, Inc.

external beam radiationU.S. Food and Drug Administrationcentral nervous systembrain tumorsThe Companypediatric patientspharmaceutical companyCompanyTrial Design