On December 15, 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 completion of the sixth dosing cohort in the ReSPECT Phase 1 clinical trial evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM) (Press release, Cytori Therapeutics, DEC 15, 2020, View Source [SID1234572872]).
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The sixth cohort of the ReSPECT trial included an increase in both the RNL drug volume and the radiation dose to 8.8 milliliters and 22.3 millicuries, respectively. RNL is designed to safely, effectively and conveniently deliver a very high dose of radiation potentially up to 15 times greater than traditional external beam radiation therapy.
Eighteen patients with recurrent GBM thus far have been treated in the ReSPECT trial. This trial is supported by the U.S. National Institutes of Health/National Cancer Institute at three trial sites in the U.S., including UT Health Science Center San Antonio and UT Southwestern Medical Center.
"The dose escalation design in ReSPECT permits both increases in drug volume and the radiation dose of RNL," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "This scheme is important as it allows us to potentially better target those malignant cells at the tumor margin that may be the source of future disease progression."
As previously disclosed, the U.S. Food and Drug Administration has granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with GBM. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385). Interim data from ReSPECT was disclosed in November 2020 at the Society of Neuro-Oncology Annual Meeting and showed that RNL was well-tolerated, with no dose-limiting toxicity observed in the first 15 patients enrolled in the trial.