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Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal Metastases
First data readout of Phase 1/Part A trial expected second half of 2023 AUSTIN, Texas, March 22, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq:
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"First data readout of Phase 1/Part A trial expected second half of 2023\nAUSTIN, Texas, March 22, 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 treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. This follows successful prior completion of Cohorts 1 and 2 as well as the recommendation of the trial’s Data and Safety Monitoring Board (DSMB) to advance into Cohort 3. Thus far, no dose-limiting toxicities have been observed with administered radiation doses of up to 26.4 millicuries. This dose represents a theoretical maximum absorbed radiation dose to the cerebral spinal fluid of approximately 200 gray. “Through Cohorts 1 and 2 and the first patient in Cohort 3, the observed safety profile and clinical signs and symptoms coupled with biological tumor cell count data of patient response, even at low, early administered doses of radiation, are encouraging,” said Norman LaFrance MD, Chief Medical Officer of Plus Therapeutics. “We remain on track to meet our key 2023 milestones for LM including a U.S. Food and Drug Administration (FDA) meeting to determine the dose expansion regime, beginning with Part B of the Phase 1 trial, and presentations of the preliminary Phase 1/Part A data at medical meetings 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, the four patients from Cohorts 1 and 2 experienced a decreased cerebrospinal fluid tumor cell count of 46% to 92% at 48 hours following treatment. The ReSPECT-LM trial 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 ...