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 富营养的Praedicare DX™是一种新兴的临床诊断测定法 预测患者对特定化学疗法的反应。与现有测定法不同，Praedicare DX™ 通过直接评估癌细胞潜力来预测对特定化学疗法的反应 接触治疗后进入凋亡状态。 Praedicare DX™具有潜力 提供可行的数据，以指导在众多中使用可用的治疗选项 癌症。 Praedicare DX™测试的当前迭代测量 线粒体。线粒体是细胞中的关键能源提供者，并破坏其 信号的功能会影响化学疗法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在几种血液癌中证明了预测价值。这 当前，测定正在用作指导急性临床治疗的分层工具 脊髓性白血病（AML）。如果成功的话，测试将成为该处理的CDX和 与制药公司的合作伙伴关系现已就位。此外，该平台已用于 慢性淋巴细胞性白血病（CML）和多发性骨髓瘤（MM）临床研究，将是 用于指导这些适应症。 该公司现在可以提供量身定制的算法读数作为分层工具 不同的临床试验。每种CDX算法的许可协议将近期提供 收入。此外，在两项单独的研究中已经验证了护理标准的临床测试 并接近商业发布。 富营养的人还正在准备相关的临床测试作为治疗特定的前列腺生物标志物， 乳房，肺和胰腺癌。下一代PRAEDICARE DX™平台现在正在 开发，我们正在与几家制药公司讨论有关合作新的 格式，最初用于RUO。