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Plus Therapeutics Completes Enrollment of Cohort 1 ReSPECT-LM Phase 1/2a Trial
Rhenium-186 NanoLiposome (186RNL) Targeted Radiotherapeutic successfully delivered without dose limiting toxicities in initial cohort Next step: Data Safety &
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"Rhenium-186 NanoLiposome (186RNL) Targeted Radiotherapeutic successfully delivered without dose limiting toxicities in initial cohort Next step: Data Safety & Monitoring Board to consider further dose escalation AUSTIN, Texas, June 16, 2022 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced the completion of enrollment in the first cohort of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM). “We are pleased with initial response to the ReSPECT-LM trial by patients and physicians and the very early promising drug performance,” said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. “Patients seemed to tolerate 186RNL infusions and the drug circulated completely and rapidly throughout the cebrebrospinal fluid space. We intend to provide enrollment and complete clinical updates in the third quarter of 2022.” The investigational drug, 186RNL, is a proprietary nanoscale compound with a unique chelated radioisotope that is administered locally as a single dose via a conventional Ommaya reservoir. Rhenium-186 is a dual energy emitter (beta and gamma) with a short average path length for high precision, low dose rate that is safer for normal tissues, and high radiation density that overwhelms innate DNA repair mechanisms. The dual energy emission allows real time evaluation and monitoring of the 186RNL administration. 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 (MTD), maximum feasible dose (MFD), safety and efficacy of a single administration of 186RNL 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 ReSPECT-LM Phase 1/2a clinical trial follows preclinical studies ...