OTHER FUNCTIONS TOPIC 277, DEVELOPING BH3 PROFILING AS A COMPANION DIAGNOSTIC FO

其他功能主题 277，开发 BH3 分析作为 FO 的伴随诊断

• 批准号: 8563432
• 负责人: MICHAEL CARDONE
• 金额: $ 149.97万
• 依托单位: EUTROPICS PHARMACEUTICALS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-28 至 2014-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8563432
• 关键词: Adverse effects; Agreement; Biological Assay; Biological Markers; Biopsy; Bone Marrow; Cancer Center; Categories; Clinical Trials; Collaborations; Companions; Complex; Contracts; Data Set; Diagnostic; FDA approved; Future; Mitochondria; Multiple Myeloma; Patients; Pharmacologic Substance; Phase; Positioning Attribute; Proteasome Inhibitor; Protocols documentation; Sampling; Sensitivity and Specificity; Technology; Testing; Treatment Efficacy; cancer cell; improved; novel; response; standard care; treatment strategy; validation studies

There is a clear need to better define patient-specific treatment strategies for the use of both standard and novel therapies for treating Multiple Myeloma (MM) both to improve efficacy and reduce unnecessary side effects. Eutropics Pharmaceuticals is uniquely positioned to improve therapy efficacy for MM 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 MM. In this phase 2 contract Eutropics will establish and deliver a refined standard operating protocol for the BH3 profiling assay and a CLlA 88 approval. Biopsied MM patient samples continue to be obtained from several academic cancer centers and pharmaceutical companies under collaboration agreements. Further partnering with additional pharmaceutical companies will be established during this contract. A verification data set will be collected. From this the specificity and sensitivity of the assay and assay cutoffs will be established. A validation study in uniformly treated clinical trials patients will follow. Completion of this study will fulfill the contract.

显然有必要更好地确定针对患者的治疗策略，使用标准疗法和新疗法治疗多发性骨髓瘤(MM)，以提高疗效并减少不必要的副作用。Eutroics制药公司通过使用一种提供新型预测生物标记物BH3图谱的专利分析方法，独特地提高了MM的治疗效率。该检测方法独一无二地评估了癌细胞的线粒体功能。这项技术在患者测试集中得到了验证，可以预测患者对MM标准治疗的反应性。在这份第2阶段合同中，Eutroics将为BH3剖析分析和CLLA 88批准建立和提供一个完善的标准操作方案。根据合作协议，活检的多发性骨髓瘤患者样本继续从几个学术癌症中心和制药公司获得。在这份合同期间，将与其他制药公司建立进一步的合作伙伴关系。将收集核查数据集。由此可以确定检测的特异度和敏感性以及检测的临界值。随后将对患者进行统一治疗的临床试验的验证研究。完成这项研究将履行合同。