Commercializing Praedicare Dx TM platform for guiding cancer treatments

将 Praedicare Dx TM 平台商业化以指导癌症治疗

• 批准号: 9767739
• 负责人: MICHAEL H CARDONE
• 金额: $ 100万
• 依托单位: EUTROPICS PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-12 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767739
• 关键词: Acute Myelocytic Leukemia; Adverse event; Agreement; Algorithms; Apoptotic; Ara-C; Biological; Biological Assay; Biological Markers; Cancer Center; Cell Death; Cell Death Signaling Process; Cells; Chronic Lymphocytic Leukemia; Clinic; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Code; Contractor; Cytarabine; Data; Data Set; Development; Diagnostic tests; Ensure; Epigenetic Process; Evaluation; Exposure to; Feedback; Genetic; Genetic Variation; Goals; Hematologic Neoplasms; Hematopoietic Neoplasms; In Vitro; Individual; Information Technology; Label; Licensing; MCL1 gene; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of pancreas; Malignant neoplasm of prostate; Measurement; Measures; Methods; Mining; Mitochondria; Multiple Myeloma; Oral; Outcome; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase II Clinical Trials; Phenotype; Physicians; Physiological; Positioning Attribute; Predictive Value; Predisposition; Prospective Studies; Provider; Regimen; Reporting; Research Personnel; Risk; Selection for Treatments; Signal Transduction; Solid Neoplasm; Stratification; Subcategory; Testing; Treatment Protocols; Velcade; arm; base; biomarker-driven; cancer cell; cancer therapy; chemotherapy; clinical application; clinical development; clinical diagnostics; clinically relevant; commercialization; companion diagnostics; diagnostic assay; flavopiridol; genetic makeup; improved; individual patient; insight; malignant breast neoplasm; multicatalytic endopeptidase complex; new technology; next generation; non-genetic; patient response; patient stratification; phase 3 study; predicting response; predictive test; prospective; research clinical testing; specific biomarkers; standard of care; tool; tumor

Abstract The Eutropics PraediCare Dx™ is an emerging clinical diagnostic assay that will be used to predict patient response to specific chemotherapies. Unlike existing assays, PraediCare Dx™ predicts response to specific chemotherapies by direct evaluation of cancer cells potential to enter into an apoptotic state following exposure to therapy. PraediCare Dx™ has the potential to provide actionable data for guiding the use of available treatment options in numerous cancers. The current iteration of the PraediCare Dx™ test measures the functionality of the mitochondria. Mitochondria are the key energy providers within the cell and disruption in their function to signal impacts susceptibility to chemotherapy induced cell death. Our functional biomarker approach has proven predictive value in several blood cancers. The assay is currently being used as a stratification tool to guide clinical treatment in Acute Myelogenous Leukemia (AML). If successful the test will become a Cdx for that treatment and a partnership with the pharma company is now in place. In addition, the platform has been used in Chronic Lymphocytic Leukemia (CML) and Multiple myeloma (MM) clinical studies and will be used to guide treatment in those indications. The company is now in position to provide tailored algorithm readouts as stratifying tools for different clinical trials. Licensing agreements for each Cdx algorithm will provide near term revenues. In addition the clinical test for standard of care has been verified in two separate studies and is nearing commercial launch. Eutropics is also preparing related clinical tests as treatment specific biomarkers for prostate, breast, lung and pancreatic cancers. This next generation PraediCare Dx™ platform is now in development and we are in discussions with several pharma companies about partnering the new format, initially for RUO use.

抽象的 Eutropics PraediCare Dx™ 是一种新兴的临床诊断检测方法，将用于 与现有检测不同，PraediCare Dx™ 可以预测患者对特定化疗的反应。 通过直接评估癌细胞的潜力来预测对特定化疗的反应 接受治疗后进入细胞凋亡状态。 提供可操作的数据，以指导在许多情况下使用现有的治疗方案 PraediCare Dx™ 测试的当前版本可测量癌症的功能。 线粒体是细胞内的关键能量提供者，并破坏细胞的能量。 信号功能影响对化疗诱导的细胞死亡的敏感性。 我们的功能性生物标志物方法已被证明对多种血癌具有预测价值。 目前，该检测被用作分层工具来指导急性期的临床治疗。 如果成功，该测试将成为该治疗的 Cdx 和诊断结果。 与制药公司的合作关系现已到位，此外，该平台已用于。 慢性淋巴细胞白血病（CML）和多发性骨髓瘤（MM）临床研究 用于指导这些适应症的治疗。 该公司现在能够提供定制的算法读数作为分层工具 近期将提供每种 Cdx 算法的不同临床试验许可协议。 此外，护理标准的临床测试已在两项独立的研究中得到验证。 并且即将投入商用。 Eutropics 还正在准备相关的临床测试作为前列腺治疗特异性生物标志物， 下一代 PraediCare Dx™ 平台现已投入使用。 开发，我们正在与几家制药公司讨论合作新产品 格式，最初供 RUO 使用。