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Plus Therapeutics Announces FDA Meeting Summary for Lead Drug Candidate
NIH-funded ReSPECT-GBM Phase 2 trial to start in 2022 ReSPECT-GBM Phase 2 to focus on 186RNL dose expansion, safety and efficacy data to support future
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"NIH-funded ReSPECT-GBM Phase 2 trial to start in 2022 ReSPECT-GBM Phase 2 to focus on 186RNL dose expansion, safety and efficacy data to support future registrational trial AUSTIN, Texas, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, 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. The key focus areas of clinical investigation of the Phase 2 trial will be: 1) further dose exploration, including both increased dosing and multiple doses, and 2) collecting additional safety and efficacy data to inform the design of the future registrational trial. Furthermore, there was agreement that in a planned future registrational trial, overall survival should be used as the primary endpoint. The Company and the FDA also agreed to hold future meeting(s) to consider the use of external data to augment the control arm in the registrational trial. “Our first formal FDA clinical meeting after in-licensing the Rhenium NanoLiposome radiotherapeutic platform was an important milestone for us,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “We received clear feedback and, as a result, we intend to begin the ReSPECT-GBM Phase 2 trial utilizing our cGMP 186RNL drug, which should begin later this year. We will provide more details in our moderated oral presentation at the European Society for Medical Oncology (ESMO) Congress later this month.” 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., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Ant...