Hutchinson's Melanotic Freckle

Prospective FORESEE trial of CNSide Cerebrospinal Fluid (CSF) Assay met key primary and secondary endpoints CNSide CSF Assay influenced clinical management decisions in over 90% of leptomeningeal metastases (LM) cases Assay demonstrated 2.8 times the diagnostic sensitivity vs. standard cytology AUSTIN, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- 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 targetCNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LMCNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisionsCNSide exhibited high specificity, with no tumor cells detected in patients without LMCNSide 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

A mobile app that uses artificial intelligence, AI, to analyze images of suspected skin lesions can diagnose melanoma with very high precision, according to a new study. A mobile app that uses artificial intelligence, AI, to analyse images of suspected skin lesions can diagnose melanoma with very high precision. This is shown in a study led from Linköping University in Sweden where the app has been tested in primary care. The results have been published in the British Journal of Dermatology. "Our study is the first in the world to test an AI-based mobile app for melanoma in primary care in this way. A great many studies have been done on previously collected images of skin lesions and those studies relatively agree that AI is good at distinguishing dangerous from harmless ones. We were quite surprised by the fact that no one had done a study on primary care patients," says Magnus Falk, senior associate professor at the Department of Health, Medicine and Caring Sciences at Linköping University, specialist in general practice at Region Östergötland, who led the current study. Melanoma can be difficult to differentiate from other skin changes, even for experienced physicians. However, it is important to detect melanoma as early as possible, as it is a serious type of skin cancer. There is currently no established AI-based support for assessing skin lesions in Swedish healthcare. "Primary care physicians encounter many skin lesions every day and with limited resources need to make decisions about treatment in cases of suspected skin melanoma. This often results in an abundance of referrals to specialists or the removal of skin lesions, which in the majority of cases turn out to be harmless. We wanted to see if the AI support tool in the app could perform better than primary care physicians when it comes to identifying pigmented skin lesions as dangerous or not, in comparison with the final diagnosis," says Panos Papachristou, researcher affiliated with Karolinska Institutet and specialist in general practice, main author of the study and co-founder of the company that developed the app. And the results are promising. "First of all, the app missed no melanoma. This disease is so dangerous that it's essential not to miss it. But it's almost equally important that the AI decision support tool could acquit many suspected skin lesions and determine that they were harmless," says Magnus Falk. In the study, primary care physicians followed the usual procedure for diagnosing suspected skin tumours. If the physicians suspected melanoma, they either referred the patient to a dermatologist for diagnosis, or the skin lesion was cut away for tissue analysis and diagnosis. Only after the physician decided how to handle the suspected melanoma did they use the AI-based app. This involves the physician taking a picture of the skin lesion with a mobile phone equipped with an enlargement lens called a dermatoscope. The app analyses the image and provides guidance on whether or not the skin lesion appears to be melanoma. To find out how well the AI-based app worked as a decision support tool, the researchers compared the app's response to the diagnoses made by the regular diagnostic procedure. Of the more than 250 skin lesions examined, physicians found 11 melanomas and 10 precursors of cancer, known as in situ melanoma. The app found all the melanomas, and missed only one precursor. In cases where the app responded that a suspected lesion was not a melanoma, including in situ melanoma, there was a 99.5 percent probability that this was correct. "It seems that this method could be useful. But in this study, physicians weren't allowed to let their decision be influenced by the app's response, so we don't know what happens in practice if you use an AI-based decision support tool. So even if this is a very positive result, there is uncertainty and we need to continue to evaluate the usefulness of this tool with scientific studies," says Magnus Falk. The researchers now plan to proceed with a large follow-up primary care study in several countries, where use of the app as an active decision support tool will be compared to not using it at all. The study was funded with support from Region Östergötland and the Analytic Imaging Diagnostics Arena, AIDA, in Linköping, which is funded by the strategic innovation programme Medtech4Health.

SAN DIEGO--(BUSINESS WIRE)--Biocept, Inc. (Nasdaq: BIOC) (“Biocept” or the “Company”), a leading provider of molecular diagnostic assays, products and services, announces that its CNSide cerebrospinal fluid assay was featured in two oral presentations at the 2023 SNO/ASCO CNS Cancer Conference on Saturday, August 12. The abstracts were presented by Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of California, San Diego. The conference, sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO), was held August 10-12 in San Francisco. “While patients with leptomeningeal metastasis (LM) have limited treatment options, select patients may benefit from targeted therapies,” said Dr. Kumthekar. “Using CNSide in patients with solid tumors and LM to detect HER2 amplification could provide valuable information in treatment decision making.” Dr. Kumthekar is the principal investigator at Northwestern University of Biocept’s ongoing FORESEE clinical trial, which is evaluating the performance of CNSide in monitoring the response of LM to treatment and assessing the impact of CNSide on treatment decisions made by physicians. “Patients with leptomeningeal carcinomatosis (LMC) have limited survival and early detection by traditional CSF cytology is poor,” said Dr. Piccioni. “From this study, we concluded that using CNSide was superior in detecting LMC, and its ability for molecular profiling on captured CSF tumor cells (CSF-TCs) could improve earlier detection and treatment outcomes.” A summary of the abstracts is as follows: “The HER2 Flip: HER2 Amplification of Tumor Cells in the Cerebrospinal Fluid (CSF-TCs) of Patients with Leptomeningeal Metastasis having solid tumors; implications for treating the LM tumor with anti-HER2 therapy.” Results of this study indicated that HER2 amplification in the CSF can be detected in a substantial fraction of CSF-TCs from patients with LM having breast, upper GI and non-small cell lung cancer, and other solid tumors, and that an increased HER2 positivity in LM may imply HER2 as a driver for developing LM. The results suggest that prospective studies are needed to determine if evaluation of HER2 amplification in the CSF of patients with LM having solid tumors should be routinely considered, as it may offer viable treatment options otherwise not considered. “Circulating tumor cell analysis from the cerebrospinal fluid informs early diagnosis, treatment and prognosis in leptomeningeal carcinomatosis (LMC).” This study compared traditional CSF cytology and circulating tumor cell (CTC) analysis using CNSide to evaluate patients for presence of LMC. The results suggested that CTC provided superior sensitivity in detecting LMC compared with traditional cytology, and allowed for earlier detection and consequently earlier treatment. Molecular analysis of CTCs also allowed for identification of therapeutic targets specific to the CSF, which provides more information for treatment decision making and potentially improves survival versus historical controls. The abstracts from both presentations are available on the Biocept website here. About Biocept Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample. Forward-Looking Statements Disclaimer This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements regarding the potential benefits and capabilities of CNSide for use in patients with LM and LMC, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors, including that the results of the FORESEE clinical trial may not support the inclusion of CNSide in clinical care guidelines; risks related to our need for additional capital and the risk that our products and services may not perform as expected. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission (SEC), including under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at .