- Plus Therapeutics Inc PSTV presented data from two ongoing trials evaluating its lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM), leptomeningeal metastases (LM).
- Data from the first oral presentation included the following key findings:
- In 24 patients with recurrent glioblastoma, a single dose of rhenium (186Re) obisbemeda was administered in the dose escalation phase, achieving up to 740 Gray (Gy) of absorbed radiation dose to the tumor.
- No dose-limiting toxicities and a good safety profile have been observed.
- A statistically significant improvement in overall survival correlated with both the average absorbed dose of radiation to the tumor and the percent volume of tumor treated, specifically:
- A 100 Gy increase in the absorbed dose correlated with a 35.7% decrease in the risk of death.
- A 1% increase in tumor volume treated is associated with a 4.5% decrease in the risk of death.
- Related: Plus Therapeutics Shares Surge On Positive Data From Lead Brain Cancer Candidate.
- A recommended Phase 2 dose of 22.3 mCi in 8.8 mL is being studied for tumor volumes of 20 mL or less and is expected to enroll up to an additional 31 patients.
- Data from the second oral presentation in LM patients exhibited that single rhenium (186Re) obisbemeda dose was well tolerated with no treatment-related adverse events greater than grade 1.
- All four patients treated in Cohorts 1 and 2 were observed to have prompt and complete rhenium (186Re) obisbemeda distribution throughout the cerebrospinal fluid subarachnoid space that was durable to 28 days.
- All patients showed a decreased CSF tumor cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%.
- Plus Therapeutics will file an Investigational New Drug application for the pediatric Phase 1/2a rhenium (186Re) obisbemeda trial in up to 24 patients with supratentorial recurrent or progressive pediatric ependymoma and high-grade glioma.
- Price Action: PSTV shares closed 4.13% lower at $0.46 on Friday.
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