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

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多发性骨髓瘤（MM），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MM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BH 3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MM标准治疗的反应性。在该第2阶段合同中，Eutropics将建立并提供用于BH 3分析测定和CLIA 88批准的精细标准操作方案。根据合作协议，继续从几个学术癌症中心和制药公司获得活检的MM患者样本。在此合同期间，将与其他制药公司建立进一步的合作伙伴关系。将收集验证数据集。由此确定试验的特异性和灵敏度以及试验临界值。随后将在统一治疗的临床试验患者中进行验证研究。完成本研究将履行合同。

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.