Plus Therapeutics to Present Data from Two Studies Supporting the Treatment of Leptomeningeal Metastases with Rhenium-186 Nanoliposome

On August 11, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted therapies for rare and difficult to treat cancers, reported it will present data from one planned clinical trial and one completed preclinical study evaluating its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, AUG 11, 2021, View Source [SID1234586310]). The data will be presented at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually August 19-20, 2021.

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Data from both studies will be presented as electronic posters (ePosters) by Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, and principal investigator, and will be viewable to meeting attendees beginning at the start of the conference on Thursday, August 19 at 11:00 am EDT. The accepted abstracts are currently available in the Neuro-Oncology Advances Journal. Details of both are as follows:

LMD-13: "ReSPECT-LM: Maximum tolerated dose, safety, and efficacy of intraventricular Rhenium-186 Nanoliposome ( 186 RNL) for leptomeningeal metastases"
Data from the ongoing U.S. multi-center ReSPECT-GBM Phase 1 dose-finding clinical trial in adults with recurrent glioblastoma (NCT01906385) demonstrate that the mean absorbed dose of 186RNL to the tumor when coverage was 75% or greater (n=10) was 392 Gy (CI 306 – 478). Thus far, the therapy has been well tolerated with one possible treatment-related serious adverse event, cerebral edema, that resolved after steroid treatment.

In addition, this abstract details a proposed two-part clinical trial for patients with leptomeningeal metastases (LM). Part 1 will enroll up to 21 subjects to characterize the safety and tolerability of a single dose of 186RNL administered intraventricularly via an Ommaya reservoir and identify a maximum tolerated dose (MTD) / maximum feasible dose (MFD) for future studies, and Part 2 will independently evaluate 186RNL in two different cohorts. Cohort A will enroll up to 20 subjects with a diagnosis of LM from primary breast cancer. Cohort B will enroll up to 20 subjects with a diagnosis of LM from primary non-small cell lung cancer. The primary endpoint is to estimate the anti-tumor activity of 186RNL as a single agent. The full abstract can be found here: View Source

LMD-14: "Preclinical safety and activity of intraventricular Rhenium-186 Nanoliposome ( 186 RNL) for leptomeningeal metastases"
As part of this preclinical safety and activity study, researchers concluded that the intraventricular delivery of 186RNL is well tolerated and improves animal survival at two weeks in a rat model of LM. The full abstract can be found here: View Source

Copies of each poster will be made available under the Presentations tab of the Investors section of the Company’s website when presentations go live at www.plustherapeutics.com.

LM are a rare but typically fatal complication of advanced cancer that affects the fluid-lined structures of the central nervous system and are diagnosed in approximately five percent of patients with metastatic cancer. With survival measured in weeks to months, novel approaches are needed that can both improve quality and quantity of life. 186RNL permits the selective delivery of beta-emitting radiation of high specific activity directly to the tumor.