-
市場
-
產品
-
資訊
-
Moo社區
-
課堂
-
查看更多
-
功能介紹
-
費用費用透明,無最低余額限制
投資選擇、功能介紹、費用相關信息由Moomoo Financial Inc.提供
- English
- 中文繁體
- 中文简体
- 深色
- 淺色
Plus Therapeutics Announces Validation & Clinical Implementation Of CSF-01 Leptomeningeal Cancer Cell Diagnostic
Plus Therapeutics Announces Validation & Clinical Implementation Of CSF-01 Leptomeningeal Cancer Cell Diagnostic
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.
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
Plus 的 CSF-01 癌細胞計數測試是針對輕腦膜中是否存在腺癌和黑色素瘤癌細胞的敏感而特異的診斷測試
CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials
CSF-01 測試被用作 Respect-LM 試驗的探索性終點
Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024
評估 CSF-01 在臨床決策中的效用的對照臨床試驗數據預計將於 2024 年第二季度/第三季度發佈
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.
得克薩斯州奧斯汀,2024年3月25日(GLOBE NEWSWIRE)——Plus Therapeutics, Inc.(納斯達克股票代碼:PSTV)(“公司”)是一家臨床階段的製藥公司,採用先進的中樞神經系統(CNS)癌症平台技術開發靶向放射治療藥物。該公司今天宣佈,它已成功完成其腫瘤細胞計數檢測(最初用作 CSF-01)的關鍵驗證測試和實施其 Respect-LM 臨床試驗中的探索性終點。
"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."
西北大學芬伯格醫學院副教授普里亞·庫姆特卡博士說:“Plus的 CSF-01 腫瘤細胞計數測定是一項高度特異和靈敏的診斷測試,有望確立輕腦膜轉移(LM)的診斷,並隨着時間的推移跟蹤疾病進程。”“目前的診斷方法缺乏靈敏度和特異性,無法可靠地爲臨床決策提供信息,該領域對在 Respect-LM 試驗中使用 CSF-01 作爲探索性終點感到興奮,希望很快能用於所有以LM進行鑑別診斷的患者。”
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.
Plus 的 CSF-01 癌細胞計數測試是 Respect-LM 1 期試驗的探索性終點,該試驗的早期隊列顯示出希望。在舊金山2023年SNO/ASCO會議上提出的Respect-LM試驗的1/A部分中,Plus顯示,在對LM患者進行單次鞘內注射瑞(186Re)obisbemeda的28天后,腦脊液腫瘤細胞平均減少了53%。
"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."
Plus Therapeutics總裁兼首席執行官馬克·赫德里克醫學博士表示:“2023年年中,公司批准了 CSF-01 以及更廣泛的腦脊液診斷測試產品組合,這是因爲我們堅信常規實施將大大改善大麻的診斷和臨床管理。”“我們最初的目標是爲我們的Respect-LM試驗患者提供該測試,該測試現已完成。現在,我們正在評估FORSEE臨床試驗數據,我們預計將在2024年第二或第三季度報告該數據。”
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).
2023 年 12 月 12 日,Plus 宣佈與 K2bio(德克薩斯州休斯頓)合作,在 Respect-LM 試驗中實施 Plus 的 CSF-01 下半球癌診斷。儘管經過驗證,可用於Plus的臨床開發計劃,但預計要到2025年才能獲得全面的臨床實驗室改進修正案(CLIA)認證。包括支持 CSF-01 測試在內的Respect-LM試驗目前正在獲得德克薩斯州癌症預防與研究所(CPRIT)的撥款。
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.
FORSEE 試驗由 CSF-01 的原始開發者和許可人進行,是一項多中心、前瞻性臨床試驗,招收了可疑或確診的乳腺癌或非小細胞肺癌 (NSCLC) 患者。如果FORSEE的數據爲陽性,我們打算努力增加CLIA認證測試的商業報銷,並探索合作夥伴關係,以最大限度地提高更廣泛的中樞神經系統癌症領域的診斷利用率。
moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
風險及免責聲明
moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd.,Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc和Moomoo Securities Malaysia Sdn. Bhd., 是關聯公司。
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用瀏覽器的分享功能,分享給你的好友吧