TREATMENT RESPONSE

Treatment-Specific Biomarkers In Prospective Clinical Studies

All cancer patients are administered some form of chemotreatment or other targeted therapy in conjunction with surgery and/or radiation. In breast cancer, several therapy regimens are commonly used which have comparable overall efficacy but differ widely in cost, duration, and potential toxicity.


Treatment selection is based on pathology tests that measure tumor size, stage, and grade whereas eligibility to certain therapies such as Tamoxifen^TM and Herceptin^TM is decided by single-marker tests, ER/PR and Her-2/neu. Although these tests in practice may help exclude certain therapies if the test results are negative, success of positive treatment selection is modest.


Patient response, as a result, is variable and sub-par in a cancer where oncologists believe patient survival can be greatly enhanced by correct choice of existing treatments.


Nuvera's treatment response programs are directed at:

1. Chemotherapy response prediction: Gene-based predictors for common breast cancer regimens have been established and are being validated with prospective neo-adjuvant clinical trials.



2. Endocrine therapy response: Treatments such as tamoxifen and aromatase inhibitors in breast cancer require markers beyond ER-positive status to fully capture response in patients. A gene-based predictor is being validated for response to endocrine treatment.



3. Broad-cancer biomarkers: Using bioinformatics and laboratory-based analyses of tissue samples and outcome data, markers have been identified with potential value in cross-cancer indications. A number of outcomes related to tumor staging, response prediction and therapeutic modulation are being evaluated.