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Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases
A total of 18 patients have been dosed in the trial to date Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review AUSTIN,
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"A total of 18 patients have been dosed in the trial to date Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review AUSTIN, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date. There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1. The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval. In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven. The Company anticipates that this will allow for continued maximal enrollment allowed under the protocol. The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for LM and Orphan Drug Designation for the treatment of breast cancer with LM, and the ReSPECT-LM program continues to be funded in part by a 3-year $17.6M grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497). About Leptomeningeal Metastases (LM)LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The...