Plus Therapeutics Presents Preliminary Safety and Feasibility Data from ReSPECT-LM Clinical Trial at the European Association of Nuclear Medicine Congress
ReSPECT-LM Phase 1 clinical trial selected as TOP Trials Oral Presentation
Treatment was well tolerated without dose limiting toxicities and all patients showed a decrease in spinal fluid tumor cell counts
ReSPECT-GBM Phase 1 clinical data selected as Top-Rated Oral Presentation and inclusion in opening Highlights Lecture
“The findings presented at EANM indicate the potential for 186RNL in patients diagnosed with leptomeningeal metastases,” said
The TOP Trials Oral Presentation titled, Safety and Feasibility of Rhenium-186 Nanoliposome (186RNL) in Leptomeningeal Metastases (LM) Phase 1 dose escalation Trial [OP-759], demonstrated:
- The 186RNL dose administered through an intraventricular catheter at 6.6 mCi in 5.0 mL in Cohort 1 achieved absorbed doses of 18.7 to 29.0 Gray to the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events of greater than grade 1.
- All four patients treated to date in Cohorts 1 and 2 were observed to have prompt and complete 186RNL distribution throughout the cerebrospinal fluid (CSF) subarachnoid space that was durable past 28 days and was well tolerated.
- All patients showed a decreased CSF cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%.
- Cohort 2 in the ReSPECT-LM trial has commenced, with interim data from the first two patient cohorts expected by the end of 2022.
- This trial is supported by the recently announced
$17.6 milliongrant by the Cancer Prevention & Research Institute of Texas(CPRIT).
The Top Rated Oral Presentation (TROP) titled, Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1/2a Trial [OP-542], reviewed data which indicate that:
- Direct administration of 186RNL is safe in patients with recurrent GBM with no dose-limiting toxicities (DLT).
- There is a statistically significant overall survival benefit observed with 186RNL radiation doses over 100 Gray. In 23 adult patients across eight cohorts of increasing dose and treated over a seven-year period, the improved median overall survival (OS) rates correlated with the absorbed tumor radiation dose.
- Patients receiving a therapeutic absorbed radiation dose (>100 Gray) had a median OS of 129.7 weeks (95% CI of 35.0-169.1) compared to those receiving a subtherapeutic absorbed radiation dose (<100 Gray) whose median OS was 22.3 weeks (95% CI of 6.4-45.3).
- The Company plans to initiate a
National Institutes of Health(NIH)-funded Phase 2 study by the end of 2022 that will utilize cGMP 186RNL and leverage a higher dose and volume that could potentially show a greater survival rate in patients with recurrent GBM.
Abstracts presented at the conference can be viewed here. A copy of the presentation is available under the Presentations tab of the Investors section of the Company’s website at https://ir.plustherapeutics.com.
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This press release contains statements that may be deemed “forward-looking statements” within the meaning of
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s
Source: Plus Therapeutics Inc.