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

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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.