Benzinga | Oct 29, 2020 07:47AM EDT

Plus Therapeutics Announces Initiation of Final Cohort of ReSPECT Glioblastoma Trial

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(tm) Phase 1 dose-finding clinical trial evaluating Rhenium NanoLiposomes (RNL(tm)) 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).