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Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase
AUSTIN, Texas, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"AUSTIN, Texas, Sept. 05, 2023 (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 cancers, today announced treatment of the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. “The Phase 1/Part A data in the ReSPECT-LM clinical trial is encouraging,” said Norman LaFrance M.D., Chief Medical Officer of Plus Therapeutics. “In Phase 1/Part B, we plan to dose escalate to the maximum tolerated single dose while simultaneously collaborating with the U.S. Food and Drug Administration (FDA) to implement multiple dosing into the trial.” The maximum total radiation activity administered in Phase 1/Part A was 26.4 millicuries (mCi). In Phase 1/Part B the maximum administered total radiation activity will be 110.0 mCi in cohort 7. Positive data from Part A (Cohorts 1-3) of the ReSPECT-LM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of LM were presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference in August 2023. In summary, the findings in the Phase 1/Part A showed: Ten patients were treated with a maximum absorbed dose of 85 Gray (Gy) and up to 26.4 mCi of radiation activity.No dose limiting toxicities have been observed and a maximum tolerated dose or maximum feasible dose has not been reached in Part A.Cerebrospinal fluid (CSF) tumor cell counts, evaluated using a molecular diagnostic assay, decreased an average of 53% measured at 28 days post-treatment.In addition, five of the 10 treated patients in Part A remain alive with a median overall survival of 10 months. The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. The ReSPECT-LM clinical trial is funded, in part, by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas. 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 c...