Plus Therapeutics (PSTV) Announces DSMB Approval to Proceed into Eighth Cohort in ReSPECT Glioblastoma Trial
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Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced that the Data and Safety Monitoring Board recommended the Company proceed to the eighth cohort of the Phase 1 dose escalation ReSPECT™ trial, which is evaluating the Company’s lead investigational drug, Rhenium NanoLiposome (RNL™), in patients with recurrent glioblastoma (GBM).
“We are pleased with the favorable safety profile observed thus far with RNL™ in recurrent GBM,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “Moving to cohort eight will allow us to continue to push the envelope in terms of addressable tumor size and maximum radiation dose delivered.”
Twenty-one patients with recurrent GBM have been treated in the ReSPECT™ trial across seven cohorts to date. In these patients, RNL™ has had no dose-limiting toxicities observed with absorbed radiation doses of up to 740 Gray per tumor.
The eighth cohort of the ReSPECT™ trial will implement a 40% increase in total radioactivity. The planned infused dose will be 31.2 millicuries in a volume of 12.3 milliliters (increased from 22.3 millicuries and 8.8 milliliters, respectively, used in cohort seven). The planned maximum flow rate will not change.
RNL™ is under investigation as a potentially safe, effective and convenient way to deliver a very high dose of radiation, possibly over 20 times greater than traditional external beam radiation therapy. 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, UT Southwestern Medical Center and UT MD Anderson Cancer Center Houston.
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).
The latest corporate information can be found on the Company’s Investor Relations page at ir.plustherapeutics.com/presentations.
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