OTHER FUNCTIONS R&D- BIOMEDICAL (BASIC RESEARCH)
OTHER FUNCTIONS R&D- BIOMEDICAL (BASIC RESEARCH)
批准号:
8556508
负责人:
MICHAEL CARDONE
金额:
$19.99万
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-20 至 2013-06-19
关键词:
Acute Myelocytic LeukemiaAdverse effectsAgreementBasic ScienceBiological AssayBiological MarkersBiopsyCancer CenterCellsClinicalCollaborationsCompanionsContractsDataDiagnosticDiagnostic testsMitochondriaOutcomePatientsPharmacologic SubstancePhasePhysiciansPositioning AttributeProtocols documentationSamplingTechnologyTestingTreatment EfficacyValidationbasecancer cellimprovednovelphase 2 studyprognosticresearch and developmentresponsestandard carestandard of caretreatment strategy
中文摘要
显然需要更好地定义患者特异性治疗策略,以使用标准和新型疗法治疗急性髓性白血病(AML),以提高疗效并减少不必要的副作用。Eutropics Pharmaceuticals具有独特的优势,通过使用专有的检测方法来提高AML的治疗效果,该检测方法提供了一种新的预测生物标志物,即BH3谱。该测定独特地评估癌细胞中的线粒体功能。该技术已在患者测试集中得到证实,可预测患者对AML标准治疗的反应性。
在第一阶段合同中,Eutropics将为基于FACS的BH3分析检测提供一个完善的标准操作方案,同时寻求CLIA 88批准。AML患者活检样本将根据合作协议从几个学术癌症中心获得,并发送到位于马萨诸塞州剑桥的Eutropics实验室。从测定中收集的数据将与医生收集的患者结局数据相关。
Eutropics将申请2期研究,该研究将提供AML的临床验证测试和标准护理和实验性AML治疗的伴随诊断测试。目前正在讨论商业合作。
英文摘要
There is a clear need to better define patient-specific treatment strategies for the use of both standard and novel therapies for treating Acute Myelogenous Leukemia (AML) both to improve efficacy and reduce unnecessary side effects. Eutropics Pharmaceuticals is uniquely positioned to improve therapy efficacy for AML by using a proprietary assay that provides a novel predictive biomarker, BH3 profiling. The assay uniquely assesses mitochondrial functionality in cancer cells. This technology is proven in a patient test set to predict the patient responsiveness to standard treatments for AML.
In this phase I contract Eutropics will deliver a refined standard operating protocol for a FACS based version of the BH3 profiling assay while seeking CLIA 88 approval. Biopsied AML patient samples will be obtained from several academic cancer centers under collaboration agreements that are in place and sent to Eutropics labs in Cambridge, MA. Data collected from the assay will be correlated with patient outcome data collected by physicians.
Eutropics will apply for the phase 2 study that will deliver a clinically validated test for AML and companion diagnostic test for standard of care and experimental AML treatments. Discussions are underway for commercial collaborations.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
IGF::CT::IGF DEVELOPMENT OF PRAEDICARE DX AS CDX FOR AMLPERIOD OF PERFORMANCE: SEPTEMBER 19, 2014 THROUGH SEPTEMBER 18, 2015
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批准号:8934461
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项目类别:
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资助金额:$149.97万
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财政年份:2014
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负责人:MICHAEL CARDONE
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依托单位:
OTHER FUNCTIONS TOPIC 277, DEVELOPING BH3 PROFILING AS A COMPANION DIAGNOSTIC FO
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批准号:8563432
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项目类别:
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资助金额:$149.97万
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财政年份:2012
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负责人:MICHAEL CARDONE
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依托单位:
海外基金