On June 29, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois (Press release, PLUS THERAPEUTICS, JUN 29, 2023, View Source [SID1234632981]).
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An oral presentation titled, Safety and Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988], brief highlights include:
Data from 21 patients in the Phase 1 trial used to support the recommended Phase 2 trial dose for patients with tumor volumes ≤20 mL was presented.
A single dose of rhenium (186Re) obisbemeda was generally safe and well-tolerated, with no dose-limiting toxicities and minimal systemic radiation exposure.
The data demonstrates efficacy signals in a prognostically unfavorable patient population.
The median overall survival (OS) in all 21 patients (including those receiving small radiation doses in early cohorts and five patients previously treated with Bevucizamab) was 11 months or a 38% increase in OS versus a median OS of approximately 8 months for standard of care in rGBM.
Median OS in patients receiving >100 Gy of absorbed radiation dose was 76 weeks (17 months) versus 22 weeks (6 months) for those receiving <100 Gy (p=0.0002).
Increased absorbed radiation dose and percent tumor volume treated correlates with improvement in overall survival, specifically:
For each 100 Gy increase of Total Dose in Distribution Volume, the risk of death decreases by 45.6% (p=0.003).
For each 10% increase in the Ratio of Treated to Total Tumor Volume, the risk of death decreases by 66.9% (p=0.002).
A poster presentation titled, Preliminary Clinical Data in The Phase 1/2a Dose Escalation Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial [P978], includes data that showed:
Interim results from 10 patients in the Phase 1 trial show a single treatment with rhenium (186Re) obisbemeda decreased cerebrospinal fluid (CSF) tumor cell count and was well-tolerated in patients with LM.
Rhenium (186Re) obisbemeda doses administered through an intraventricular catheter (Ommaya reservoir) showed prompt, complete and durable distribution throughout the CSF through Day 7.
A single rhenium (186Re) obisbemeda administered dose between 6.6 mCi and 26.4 mCi achieved absorbed doses of up to 88.98 Gy to the ventricles and cranial subarachnoid space.
No dose limiting toxicities were observed and safety observations were generally minor and resolved.
Phase 1/Part B, for continued dose escalation (Cohorts 4-7), will open following review by the U.S. Food and Drug Administration, and repeated dosing will be explored. An expansion in Cohort 3 is currently enrolling eligible patients.
A full update will be provided at the SNO/ASCO CNS Cancer Conference in August 10-12, 2023.
"Our Phase 1 ReSPECT-GBM trial has shown feasibility, safety and a strong correlation between both absorbed tumor radiation dose and tumor coverage," said Norman LaFrance, M.D., Chief Medical Officer of Plus Therapeutics. "As Phase 1 trials are designed for safety, statistically significant correlations between dose and overall survival are unusual. We are currently on track to complete the Phase 2 trial in late 2024 while we continue to extend the open Phase 1 dose escalation trial, which is now enrolling patients at approximately twice the radiation dose of the current Phase 2, without dose limiting toxicities observed thus far."
Copies of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at View Source
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).