CREATV BIO ANNOUNCES ITS CAML BIOMARKER INCLUDED IN PIVOTAL PHASE 3 TRIAL IN METASTATIC BREAST CANCER
CREATV BIO ANNOUNCES ITS CAML BIOMARKER INCLUDED IN PIVOTAL PHASE 3 TRIAL IN METASTATIC BREAST CANCER
MONMOUTH JUNCTION, N.J., July 31, 2024 /PRNewswire/ -- Creatv Bio, a Division of Creatv MicroTech, Inc. (Creatv) announced that its Cancer Associated Macrophage-Like (CAML) liquid biopsy biomarker has been included as part of the pivotal Phase 3 trial of BriaCell Therapeutics Corporation's lead clinical candidate, Bria-IMT in combination with an immune checkpoint inhibitor in metastatic breast cancer.
Creatv生物技術部門(Creatv)宣佈，其癌症相關巨噬細胞樣(CAML)液體活檢生物標誌物已作爲BriaCell Therapeutics Corporation的主要臨床候選藥物Bria-IMt在轉移性乳腺癌中的關鍵第三階段試驗的一部分。與免疫檢查點抑制劑結合進行的治療，而晚期轉移性乳腺癌患者選擇了醫生的選擇治療，沒有經過批准的替代療法可用（在ClinicalTrials.gov上列爲NCT06072612）。
This study is expected to enroll a total of 404 patients in two arms – Bria-IMT in combination with an immune checkpoint inhibitor versus treatment of physicians' choice in late-stage metastatic breast cancer patients, with no approved alternative therapies available (listed on ClinicalTrials.gov as NCT06072612). Bria-IMT was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).
這項研究預計招募404名受試者，分爲兩組——Bria-IMt與免疫檢查點抑制劑結合治療組與晚期轉移性乳腺癌患者的醫生選擇治療組，沒有批准的替代療法可用（在ClinicalTrials.gov上列爲NCT06072612）。Bria-IMt已獲得美國食品藥品監督管理局(FDA)授予的快速通道地位。
Blood samples are being provided to Creatv to analyze for the presence of circulating tumor cells (CTCs), CAML subtyping, and to monitor PD-L1 upregulation in patients. The samples are being taken at baseline and at a designated time following the initial patient treatment.
Creatv正提供血樣以分析循環腫瘤細胞(CTCs)和CAML亞型的存在，並監測患者中PD-L1上調情況。這些樣本將在初診治療後的指定時間和基線時獲取。
Creatv previously demonstrated that CAMLs can accurately (i) predict a cancer's aggressiveness as well as multi-organ metastasis, (ii) provide a universal companion diagnostics tool using blood instead of tissue from patients, (iii) predict treatment response within approximately 30 days of receiving a new therapy in any solid tumor type, (iv) detect minimal residual disease, and (v) cancer recurrence.
Creatv此前已經證明，CAMLs可以準確(i)預測癌症的侵襲性以及多器官轉移，(ii)提供一種使用患者血液而非組織的通用伴侶診斷工具，(iii)預測任何實體腫瘤類型的新療法在接受約30天后的治療反應，(iv)檢測最小殘留病, 以及(v)癌症復發。
"The use of biomarkers like CAMLs holds great promise in helping clinicians determine whether a patient is responding to a specific therapy in a timely manner," remarked Dr. Cha-Mei Tang, President and CEO of Creatv Bio. "We are looking forward to participating in this important trial with BriaCell and are confident that as a result, this biomarker will provide clinicians with a valuable tool to guide their treatment choices for cancer patients."
CreatvBio總裁兼首席執行官唐查梅博士表示：“像CAML這樣的生物標誌物在幫助臨床醫生及時判斷患者是否對特定療法做出反應方面有着巨大的潛力。我們期待與BriaCell參與這項重要的試驗，並相信這個生物標誌物將爲臨床醫生提供一個有價值的工具，以指導癌症患者的治療選擇。”
About Creatv Bio
Creatv是一家提供癌症篩查和癌症診斷服務的公司，從其位於新澤西州的CLIA/CAP實驗室爲患者提供檢測，支持藥物開發。Creatv的科學家們是首次出版發現CAMLs存在於癌症患者的血液中的人員。自2014年首次發表以來，數十個全球獨立組織已經驗證了CAMLs。有關我們的期刊出版物和海報的完整列表，請訪問我們的網站。
Creatv is a cancer screening and cancer diagnostics company providing testing services to patients and to support drug development from its CLIA/CAP laboratory in NJ. Creatv's scientists were the first to publish CAMLs found in the blood of cancer patients. Since this original publication in 2014, CAMLs have been validated by dozens of independent groups worldwide. For a complete listing of our journal publications and posters, please visit our website at .
Creatv是一家癌症篩查和癌症診斷公司，在其NJ的CLIA/CAP實驗室爲患者提供測試服務，並支持藥物開發。Creatv的科學家最早發現了癌症患者血液中的CAML。自2014年原始出版物以來，CAML已經由全球數十個獨立研究組驗證。有關我們的期刊出版物和海報的完整列表，請訪問我們的網站。
For more information contact:
有關更多信息，請聯繫以下人員：:
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Daniel Adams, |
Ron Baker |
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Director of Clinical R&D |
Chief Business Officer |
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[email protected] |
[email protected] |
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732-783-7132 (office) |
301-785-5185 (mobile) |
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丹尼爾·亞當斯, |
羅恩·貝克 |
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臨床研發董事 |
業務主管 |
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[email protected] |
[email protected] |
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732-783-7132（辦公室） |
301-785-5185（手機） |
SOURCE Creatv MicroTech, Inc.
來源：創想微科技公司