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Plus Therapeutics Completes Fifth Dose Escalation Cohort of the ReSPECT™ Glioblastoma Clinical Trial and Expands Trial Sites

Written by Customer Service on . Posted in Public Companies.

AUSTIN, Texas, July 28, 2020 (GLOBE NEWSWIRE) — Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”) today announced the successful completion of the fifth cohort of the ReSPECT Clinical Trial and expansion to a second clinical trial site, the UT Southwestern Medical Center in Dallas.
The Phase 1 ReSPECT Clinical Trial is intended to assess the safety, tolerability, and distribution of a novel radiotherapy, Rhenium NanoLiposomes (RNL™), in adults with recurrent glioblastoma (GBM) after standard surgical, radiation, and chemotherapy treatment. ReSPECT is supported by an award from the National Cancer Institute through Phase 2 development. Glioblastoma is a rare, incurable, and fatal disease with a median survival of about nine months following recurrence despite the current standard of care.Patient screening and enrollment at UT Southwestern Medical Center is ongoing and will be led by principal investigator and neurosurgeon, Toral Patel, MD. “We are pleased to add the UT Southwestern Medical Center team led by Dr. Patel to our trial,” said Dr. Andrew Brenner, MD, PhD, who is the principal investigator of the trial and is the Kolitz Chair in Neuro-Oncology Research and Co-Leader of the Experimental and Developmental Therapeutics Program at UT Health San Antonio MD Anderson Cancer Center. “Convection-enhanced delivery of RNL directly into the tumor represents a promising new local radiation treatment option for recurrent GBM patients.” Plans are underway to expand ReSPECT to another site, the MD Anderson Cancer Center in Houston. To-date, the study has enrolled 15 patients across five cohorts at the UT Health Science Center San Antonio, with one more cohort of six patients planned to fully complete enrollment.In ReSPECT, very high therapeutic doses of a high energy beta-emitting radioisotope, Rhenium-186, are precisely delivered directly into the brain tumor via stereotactic technology and convection-enhanced delivery (CED). Studies have demonstrated that CED holds great promise in terms of local drug penetration through the brain extracellular matrix/space. The local radiation delivered to the brain tumor with RNL is intended to be up to 25 times greater than that currently being given to patients using external beam radiation therapy (EBRT). Thus far, the highest absorbed radiation dose delivered to a patient’s tumor in ReSPECT is approximately 15 times the level typically delivered by EBRT.The Company expects additional near-term ReSPECT and RNL developments to include:Continued dose escalation and expansion of delivery parameters through cohort 6.Completion of enrollment of the Phase 1 Trial.Determination of the recommended Phase 2 dose.Submission of applications for Orphan Disease Designation in the U.S. and Europe.Submission of an application for Fast Track Designation in the U.S.Data analysis and reporting of the ReSPECT Clinical Trial Results.Presentation by the Company for plans to expand RNL clinical development for multiple indications.About Plus Therapeutics, Inc.

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