On November 20, 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 data from the ongoing ReSPECT-GBM Phase 2 trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) at the Society for NeuroOncology (SNO) 28th Annual Meeting held November 15-19, 2023 in Vancouver, Canada (Press release, Cytori Therapeutics, NOV 20, 2023, View Source [SID1234637831]). The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET. To register for the event, please click here.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"GBM needs better treatment options, and we are highly encouraged by the initial data from the NIH-supported ReSPECT-GBM Phase 2 trial of rhenium (186Re) obisbemeda in rGBM," said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. "We believe the data presented at SNO suggests that rhenium (186Re) obisbemeda confers a survival benefit over published standard of care data and our own real world data assessments of propensity matched controls. Our 2024 focus will be onboarding additional clinical sites, completing Phase 2 enrollment, continuing the phase 1 trial to maximum tolerated dose, and planning next steps for the program."

"The interim ReSPECT-GBM Phase 2 data coupled with the novel imaging analyses reported at SNO further strengthens the compelling therapeutic rationale for the use of rhenium (186Re) obisbemeda on malignant gliomas," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. "The Phase 2 clinical outcomes thus far, show effects consistent with the group of patients in the Phase 1 dose escalation trial that received both a therapeutic dose of radiation of greater than 100 Gy and tumor coverage of greater than 70%."

Key Highlights from the ReSPECT-GBM Phase 2 Trial

ReSPECT-GBM is an ongoing, first-in-human, open-label, Phase 1/2 study investigating dose escalation and other delivery parameters (i.e., number of catheters (1-5), infusion rates, drug volumes, and drug concentrations) to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and efficacy of rhenium (186Re) obisbemeda in recurrent adult glioma (IND 116117).

The primary objective of the Phase 2 study is to assess overall survival (OS) following rhenium (186Re) obisbemeda administration. As of November 14, 2023, 15 patients with rGBM have been treated with rhenium (186Re) obisbemeda at a dose of 22.3 mCi delivered directly to the tumor by Convection Enhanced Delivery (CED).

•
In 15 treated patients, mOS is 13 months (95% CI 5 months). Currently, 9 out of the 15 treated patients remain alive.

•
Median PFS is 11 months (95% CI 6-11 months).

•
The average percent of treated tumor across all 15 patients was 87.2% at 120 hours, with 13/15 patients receiving greater than or equal 70% tumor volume coverage by the drug and ≥100 Gy absorbed dose to the tumor.

•
Advanced longitudinal imaging analysis supports the observed efficacy signal of rhenium (186Re) obisbemeda.

•
Rhenium (186Re) obisbemeda continues to be generally safe and well tolerated, consistent with data accumulated in the Phase 1 trial.

A copy 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

KOL Webinar to Discuss SNO Data

Plus Therapeutics is hosting a virtual KOL event today, November 20, 2023 at 10:00 am ET to discuss the data presented at SNO. The event will feature neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery, S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D. (UT Southwestern Medical Center, Peter O’Donnell Jr. Brain Institute) and John Floyd, M.D. (UT Health San Antonio, UT Health Medical Arts & Research Center).

To register for the event, please click here. A replay of the event will be available on Investor Relations section of the Plus Therapeutics website after the event.

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).