CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus
Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”),
will present data from the FORESEE trial showcasing the CNSide CSF
Assay Platform’s utility in diagnosing and guiding clinical
decision making for breast cancer and non-small cell lung cancer
patients with LM. The data will be presented at the 2024 Society
for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston,
Texas.
“Current gold standard CSF cytology lacks the
sensitivity needed to reliably diagnose LM in most clinical
situations and lacks utility for disease monitoring,” said Marc H.
Hedrick, M.D., Plus Therapeutics’ President and Chief Executive
Officer. “The FORESEE trial shows that CNSide may be a useful tool
in accurately identifying all patients with LM, ruling out patients
at risk, and enhancing the disease management and monitoring of
LM.”
Key highlights:
- The FORESEE trial achieved its
primary endpoint, demonstrating that CNSide influenced treatment
decisions in over 90% of cases evaluated, surpassing the
predetermined 20% primary endpoint target
- CNSide demonstrated enhanced
sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%)
in patients with LM
- CNSide identified actionable
mutations in the CSF, such as HER2 amplification, influencing 24%
of therapeutic selection decisions
- CNSide exhibited high specificity,
with no tumor cells detected in patients without LM
- CNSide demonstrated improved
Negative Predictive Value in ruling out LM (25%) vs. CSF cytology
(10%)
- CNSide revealed HER2 positivity in
LM tumors in 60% of breast cancer patients with HER2-negative
primary tumors, informing physician treatment strategies
The data will be presented on Sunday, November
24, at 10:15 a.m. CST in a session titled, “CSF Tumor Cell (CSF-TC)
Detection, Quantification and Biomarker assessment Helps in
Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer
Patients Having Leptomeningeal Disease (FORESEE Study,
NCT-5414123),” by Priya Kumthekar, M.D., Associate Professor of
Neurology and Hematology/Oncology, and Director of Brain Metastases
Program at Northwestern, University, Chicago, Illinois.
About CNSide Diagnostic,
LLCCNSide Diagnostics, LLC is a wholly owned subsidiary of
Plus Therapeutics, Inc. that develops and commercializes
proprietary clinical diagnostic laboratory assays, such as CNSid,
designed to identify tumor cells that have metastasized to the
central nervous system in patients with carcinomas and melanomas.
The CNSid Assay Platform enables quantitative analysis and
molecular characterization of tumor cells and circulating tumor DNA
in the cerebrospinal fluid that inform and improve the clinical
management of patients with leptomeningeal metastases. The Company
is planning to commercialize CNSide in the U.S. in 2025.
About CNSide TestThe CNSide
Cerebrospinal Fluid (CSF) Assay Platform consists of four
laboratory developed tests (LDTs) used for diagnosis, treatment
selection, and treatment monitoring of patients with Leptomeningeal
Metastases (LM) from carcinomas or melanoma. The CNSide platform
facilitates tumor cell detection / enumeration and biomarker
identification using cellular assays (immunocytochemistry (ICC) and
fluorescence in situ hybridization (FISH)) and molecular assays
(next generation sequencing (NGS)). The CNSide CSF tumor cell
enumeration LDT is currently being used in the ReSPECT-LM trial as
an exploratory endpoint, and is anticipated to become commercially
available in 2025.
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 incidence of LM is on the rise, partly
because cancer patients are living longer and partly because many
standard chemotherapies cannot reach sufficient concentrations in
the spinal fluid to kill the tumor cells; yet, there are no
FDA-approved therapies specifically for LM patients, who often
succumb to this complication within weeks to several months, if
untreated.
About FORESEE Clinical
Trial
The FORESEE Study is a multi-center, prospective
clinical trial enrolled patients with Breast or Non-Small Cell Lung
Cancer (NSCLC) who have suspicious or confirmed Leptomeningeal
Metastases (LM). Standard of Care methods to diagnose or assess the
treatment response of LM (Clinical Evaluation, MRI and Cytology)
have limited sensitivity and specificity. This creates challenges
for physicians to manage LM or determine the best course of
treatment. The goal of the FORESEE Study was to evaluate the
performance of CNSide in monitoring the LM's response to treatment
and to assess the impact of CNSide on treatment decisions made by
physicians.
About Rhenium (186Re)
obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable
radiotherapy specifically formulated to deliver direct targeted
high dose radiation in CNS tumors in a safe, effective, and
convenient manner to optimize patient outcomes. Rhenium (186Re)
obisbemeda has the potential to reduce off target risks and improve
outcomes for CNS cancer patients, versus currently approved
therapies, with a more targeted and potent radiation dose.
Rhenium-186 is an ideal radioisotope for CNS therapeutic
applications due to its short half-life, beta energy for destroying
cancerous tissue, and gamma energy for real-time imaging. Rhenium
(186Re) obisbemeda is being evaluated for the treatment of
recurrent glioblastoma and leptomeningeal metastases in the
ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is
supported by an award from the National Cancer Institute (NCI),
part of the U.S. National Institutes of Health (NIH), and
ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer
Prevention & Research Institute of Texas (CPRIT).
About Plus TherapeuticsPlus
Therapeutics, Inc. is a clinical-stage pharmaceutical company
developing targeted radiotherapeutics for difficult-to-treat
cancers of the central nervous system with the potential to enhance
clinical outcomes for patients. Combining image-guided local beta
radiation and targeted drug delivery approaches, the Company is
advancing a pipeline of product candidates with lead programs in
recurrent glioblastoma (GBM) and leptomeningeal metastases (LM).
The Company has built a supply chain through strategic partnerships
that enable the development, manufacturing, and future potential
commercialization of its products. Plus Therapeutics is led by an
experienced and dedicated leadership team and has operations in key
cancer clinical development hubs including Austin and San Antonio,
Texas. For more information, visit
https://plustherapeutics.com/.
Cautionary Statement Regarding
Forward-Looking StatementsThis presentation contains
statements that may be deemed “forward-looking statements” within
the meaning of U.S. securities laws, including statements regarding
clinical trials, expected operations and upcoming developments. All
statements in this press release other than statements of
historical fact are forward-looking statements. These
forward-looking statements may be identified by future verbs, as
well as terms such as “potential,” “anticipating,” “planning” and
similar expressions or the negatives thereof. Such statements are
based upon certain assumptions and assessments made by management
in light of their experience and their perception of historical
trends, current conditions, expected future developments and other
factors they believe to be appropriate. These statements include,
without limitation, statements regarding the following: the uses
and benefits of the CNSide CSF Assay Platform, and predicted
timeline for commercialization of the CNSide CSF tumor cell
enumeration test.
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 to fund its operations in the near term and long
term, on terms acceptable to us or at all; the outcome of the
Company’s partnering/licensing efforts; risks associated with laws
or regulatory requirements applicable to the Company, including the
ability to come into compliance with The Nasdaq Capital Market
listing requirements; market conditions; product performance;
litigation or potential litigation; 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; manufacturing and supply chain
risks; 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 ContactCharles Y.
Huang, MBADirector of Capital Markets and Investor RelationsOffice:
(202)-209-5751 | Direct
(301)-728-7222chuang@plustherapeutics.com
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