Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT™ Glioblastoma Trial
Data and Safety Monitoring Board evaluated safety data in recommending cohort progression
AUSTIN, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), today announced that it has treated the first patient in the sixth and final cohort of its National Cancer Institute (NCI)-supported, multi-center ReSPECT™ Phase 1 dose-finding clinical trial evaluating Rhenium NanoLiposomes (RNL™) for the treatment of recurrent glioblastoma (GBM). Initiation of the sixth dose cohort follows successful completion of the fifth cohort and clearance from the ReSPECT trial’s Data and Safety Monitoring Board (DSMB).
The sixth cohort of the ReSPECT trial includes an increase in both the RNL drug volume and 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, with a dose that is up to 25 times greater than currently used external beam radiation therapy, directly into the brain tumor for maximum effect.
“Cohort progression in our ReSPECT trial represents another milestone toward the trial’s first major readout,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “The RNL drug volume and dose in cohort six should allow us to target the majority of glioblastoma tumors found in the recurrent setting.”
Plus Therapeutics will be presenting data from the ReSPECT clinical trial at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting being held virtually November 19-21, 2020. The Company will be providing detailed interim safety, tolerability, dosing and efficacy data of RNL in adults with recurrent GBM after standard surgical, radiation and chemotherapy treatment.
ReSPECT is currently supported by an award from the NCI. The Company plans to complete enrollment in the Phase 1 trial by the end of 2020 and in parallel will utilize its recently awarded U.S. Food and Drug Administration Orphan Drug and Fast Track designations to determine the next steps for the program.
Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).
About Plus Therapeutics, Inc.
Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company’s drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at plustherapeutics.com and respect-trials.com.
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