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Plus Therapeutics Completes Enrollment in Second ReSPECT-LM Phase 1 Trial Cohort of Rhenium (¹⁸⁶Re) Obisbemeda for the Treatment of Leptomeningeal Metastases
Topline feasibility, safety and biological response data from Phase 1/Part A anticipated in the second half of 2023 AUSTIN, Texas, Feb. 01, 2023 (GLOBE
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"Topline feasibility, safety and biological response data from Phase 1/Part A anticipated in the second half of 2023\nAUSTIN, Texas, Feb. 01, 2023 (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 cancers, today announced completion of enrollment in Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM). “Based on the significant clinical need in LM and promising early data, we continue to see increasing interest from top U.S. cancer centers in the ReSPECT-LM Phase 1/2a trial,” said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. “Next steps, following the Data and Safety Monitoring Board (DSMB) review anticipated next month, will be completing enrollment in the Phase 1/Part A, followed by a meeting with the U.S. FDA to consider dose expansion in the Phase 1/Part B trial. Additionally, initial data from the Phase 1/Part A is anticipated in the second half of 2023.” At the 2022 Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), Plus Therapeutics presented Phase 1 data from the ReSPECT-LM trial demonstrating that a single administered dose of rhenium (186Re) obisbemeda was feasible, safe and well-tolerated across two dosages in four patients from Cohorts 1 and 2, with patients experiencing a decreased cerebrospinal fluid tumor cell count at 48 hours following treatment of 46% to 92%. The ReSPECT-LM trial (NCT05034497) is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose, maximum feasible dose, safety and efficacy of a single administration of rhenium (186Re) obisbemeda via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. The U.S. Food and Drug Administration has granted Fast Trac...