Plus Therapeutics Announces FDA Meeting Summary for Lead Drug Candidate (GlobeNewswire) - Sep 6, 2022 - "Plus Therapeutics, Inc...announced today a summary of its Type C Clinical meeting minutes with the U.S. Food and Drug Administration (FDA) relating to its lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with recurrent glioblastoma (GBM)....The FDA and Plus Therapeutics agreed that the ReSPECT-GBM clinical trial should proceed to the planned Phase 2....In August 2022, the Company reported FDA feedback on its Chemistry, Manufacturing and Controls (CMC) focused Type C meeting. Planned cGMP production of 186RNL targeted radiotherapeutic is expected to begin in the second half of 2022 to support the ReSPECT Phase 2 clinical trial. On September 9, 2022, the ReSPECT-GBM trial principal investigator, Andrew Brenner, M.D., Ph.D...will provide a full update on the Phase 1 trial and discuss the clinical development overview during the ESMO Congress."
FDA event • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor
|