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Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic | ||
By: GlobeNewswire - 25 Mar 2024 | Back to overview list |
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Plus’ CSF-01 cancer cell enumeration test is a sensitive and specific diagnostic test for the presence of adenocarcinoma and melanoma cancer cells in the leptomeninges CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024 AUSTIN, Texas, March 25, 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 successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials. “Plus’ CSF-01 tumor cell enumeration assay is a highly specific and sensitive diagnostic test that is promising for both establishing the diagnosis of leptomeningeal metastases (LM) and following the disease course over time,” said Dr. Priya Kumthekar, Associate Professor, Feinberg School of Medicine, Northwestern University. “Current diagnostic methods lack the sensitivity and specificity to reliably inform clinical decision making, and the field is excited about the use of CSF-01 in the ReSPECT-LM trials as an exploratory endpoint and hopefully soon, for use in all patients in which LM is in the differential diagnosis.” Plus’ CSF-01 cancer cell enumeration test is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in the trial’s early cohorts. In Phase 1/Part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM. “In mid-2023, the Company licensed CSF-01, as well as a broader CSF diagnostic testing portfolio due to high conviction that routine implementation will substantially improve diagnosis and clinical management of LM,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “Our initial objective was to make the test available for our ReSPECT-LM trial patients, which is now complete. Now, we are evaluating the FORSEE clinical trial data, which we anticipate reporting in the second or third quarter of 2024.” On December 12, 2023, Plus announced its partnership with K2bio (Houston, Texas) to implement Plus’ CSF-01 diagnostic for LM cancers in the ReSPECT-LM trials. While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025. The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). The FORSEE trial was performed by the original developer and licensor of CSF-01 and is a multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed LM. If the FORSEE data is positive, we intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space. About Leptomeningeal Metastases (LM) About Rhenium (186Re) obisbemeda About Plus Therapeutics Cautionary Statement Regarding Forward-Looking Statements The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are 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, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so. Investor Contact |
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