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Syndax Announces Start of NCI Sponsored Phase 2 Study of Entinostat in Combination in Triple Negative Breast Cancer
Date:3/1/2011

WALTHAM, Mass., March 1, 2011 /PRNewswire/ -- Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, announced the National Cancer Institute (NCI) will sponsor a multi-center phase 2 study of Syndax's lead product entinostat, a novel inhibitor of histone deacetylases (HDAC), and anastrozole, an aromatase inhibitor, in postmenopausal women with operable triple negative breast cancer to evaluate biomarkers and surrogates for response. The trial, to be conducted under a Cooperative Research and Development Agreement (CRADA) executed between the NCI and Syndax, will investigate whether patient tumors can be reprogrammed to express estrogen receptor and render them to be sensitive to hormonal agents. This trial is based on animal data being published in the March 1, 2011, issue of Cancer Research.

Laboratory studies by Dr. Angela Brodie, professor of pharmacology and experimental therapeutics, and Gauri J. Sabnis, Ph.D., assistant professor of pharmacology and experimental therapeutics at the University of Maryland School of Medicine, in collaboration with Saraswati Sukumar, M.S., Ph.D., professor of oncology and pathology at the Johns Hopkins University School of Medicine, provided the basis for the phase 2 clinical trial. Their work demonstrates that entinostat induces hormone sensitivity in an animal model of triple negative breast cancer and that the combination with aromatase inhibitors prevents tumor growth as well as tumor metastasis.

"In the pre-clinical study that is being published in Cancer Research we demonstrated that entinostat can induce re-expression of estrogen receptor and aromatase in triple negative breast cancer cell lines and render them sensitive to an aromatase inhibitor," said Saranya Chumsri, M.D., assistant professor of medicine at the University of Maryland School of Medicine and a medical oncologist at the University of Maryland Marlene and Stewart Greenebaum Cancer Center, principal investigator
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SOURCE Syndax Pharmaceuticals, Inc.
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