On November 19, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported positive new interim data from its ongoing ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, PLUS THERAPEUTICS, NOV 19, 2020, View Source [SID1234572301]). These results were presented in an electronic poster entitled, "Safety and Feasibility of Rhenium-186 Nanoliposomes (RNL) in Recurrent GBM: the ReSPECT Phase 1 Trial," at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, which is taking place virtually November 19-21, 2020.
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!
The interim data set shows that intratumoral RNL can successfully deliver up to fifteen times the absorbed dose of radiation administered by standard external beam radiation therapy (EBRT) without significant toxicity. These data support progression to the ReSPECT trial’s sixth dose escalation cohort.
"The results we have seen thus far from ReSPECT are encouraging and support the continued development of RNL as a potential new option for recurrent GBM patients," said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the study. "With limited therapeutic options for these patients, we remain committed to advancing this clinical program to further investigate the therapeutic potential of RNL."
"Treatment for glioblastoma remains a significant challenge as current therapies have exhibited limited efficacy," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "RNL’s novel design allows the drug to be targeted directly into the tumor using a small catheter and enabling greater control of radiation dosing. These encouraging data reinforce RNL’s potential to deliver targeted high-dose radiation in a safe, effective, and convenient manner."
Key R esults from the I nterim A nalysis
All 15 patients in the first five of six planned cohorts have completed treatment.
RNL treatment volume and radiation dose increased successfully from 0.66 milliliter (mL) to 8.8 mL and 1.0 millicurie (mCi) to 22.3 mCi, respectively.
Cohort 5 patients received an RNL average absorbed radiation dose of 423 Gray (Gy).
RNL has been well-tolerated, and no dose-limiting toxicity has been observed despite markedly higher absorbed doses of radiation compared to EBRT.
Most adverse events (AEs) were considered causally unrelated to RNL except scalp discomfort, which was considered related to the surgical procedure. Neither the incidence nor severity of AEs appeared to increase with increasing doses of RNL.
Four serious adverse events (SAEs) were reported, none of the SAEs were considered causally related to RNL.
Median survival duration in patients that previously received bevacizumab (n=7) was 4.8 months, while median and mean survival durations in patients that were bevacizumab-naïve (n=8) are currently 11.0 months (range 3.5 – 33) and 15.4 months (95% CI 7.4 – 23.4), respectively, with four patients still alive.
Two patients survived greater than 30 months after therapy with RNL.
The sixth dose escalation cohort of the ReSPECT trial is underway and one patient has thus far been treated. The sixth cohort is expected to fully enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration (FDA) granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).
Webinar details
The Company will host a webinar today, Thursday, November 19, 2020, 4:30 to 5:30 p.m. ET discussing these data. Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio, will provide an update on the ReSPECT trial and provide insight on the trial data. In addition, a patient with recurrent GBM from the ReSPECT trial will provide their treatment experience with RNL.
Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics, and Gregory D. Stein, M.D., M.B.A., Senior Vice President, Clinical Development of Plus Therapeutics, will discuss the technology behind RNL as well as the current treatment landscape and unmet medical need in treating patients with recurrent GBM.
The live webinar with accompanying slides will be available in the Events page of the ‘Investors’ section of the Plus Therapeutics website or by clicking here. Individuals can participate in an interactive Q&A session by submitting pertinent questions via the webcast platform.
Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events section of the Company’s website for 90 days.
A live audio conference will be available by dialing (833) 340-0285 (toll-free) or (236) 712-2475 and entering Conference ID 6095968.
Andrew J. Brenner, M.D., Ph.D.
Dr. Brenner is a nationally known expert in the treatment of brain and breast cancers, with a particular research interest in developing new treatments. He has served on multiple committees and panels including for the National Institutes of Health, National Cancer Institute, Department of Defense Breast Cancer Research Program, and others. He has also served on advisory committees for a number of companies to help direct development of new drugs. His laboratory work developing new treatments has been funded by the Food and Drug Administration, National Cancer Institute, and Cancer Prevention and Research Institute of Texas. He has published nearly 50 original research articles in peer reviewed journals. Dr. Brenner is a member of the Plus Therapeutics Scientific Advisory Board.